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Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub- : Disinfectants
stance/Mixture
Recommended restrictions : Restricted to professional users.
on use
1.3 Details of the supplier of the safety data sheet
Producer/Supplier : Schülke & Mayr GmbH
Robert-Koch-Str. 2
22851 Norderstedt
Germany
Telephone: +4940521000
Telefax: +494052100318
mail@schuelke.com
www.schuelke.com
2. Hazards identification
Corrosive Dangerous
for the envi-
ronment
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
In the EU, this product falls under the Directive medical devices 93/42/EEC.The product is classi-
fied and labelled in accordance with EC directives or respective national laws.
3. Composition/information on ingredients
3.2 Mixtures
Chemical nature : Solution of the following substances with harmless additives.
Hazardous components
Chemical Name Index-Number Classification Classification Concentration
CAS-No. (67/548/EEC) (REGULATION [%]
EC-No. (EC) No
Registration 1272/2008)
number
Cocosalkylpropylen- 85681-60-3 Xn; R22 Acute Tox. 4; H312 14 %
diaminbiguanidinium- 288-198-7 C; R34 Skin Corr. 1B;
diacetat N; R50 H314
Aquatic Acute H400
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
M-Factor 10
Ethanol 603-002-00-5 F; R11 Flam. Liq. 2; H225 5 - 15 %
64-17-5
200-578-6
01-
2119457610-
43-XXXX
For the full text of the R-phrases mentioned in this Section, see Section 16.
For the full text of the H-Statements mentioned in this Section, see Section 16.
In case of skin contact : Wash off immediately with plenty of water for at least 15
minutes.
If symptoms persist, call a physician.
In case of eye contact : In case of eye contact, remove contact lens and rinse imme-
diately with plenty of water, also under the eyelids, for at least
15 minutes.
Obtain medical attention.
4.2 Most important symptoms and effects, both acute and delayed
Symptoms : Treat symptomatically.
4.3 Indication of any immediate medical attention and special treatment needed
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
5. Firefighting measures
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
DNEL
Propan-2-ol : End Use: Workers
Exposure routes: Skin contact
Potential health effects: Chronic effects
Value: 888 mg/m3
PNEC
Propan-2-ol : Fresh water
Value: 140,9 mg/l
Marine water
Z11074 EN Page 5/15 0081787346
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Marine sediment
Value: 552 mg/kg
Soil
Value: 28 mg/kg
Engineering measures
Ensure that eyewash stations and safety showers are close to the workstation location.
Personal protective equipment
Respiratory protection : No personal respiratory protective equipment normally re-
quired.
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Propan-2-ol: 12 %(V)
Flammability : Does not sustain combustion.
Explosive properties : Not explosive
Oxidizing properties : not applicable
Auto-ignition temperature : not applicable
pH : ca. 9, 20 °C, concentrate
Melting point/freezing point : < -5 °C
Decomposition temperature no data available
Boiling point/boiling range : ca. 90 °C
Vapour pressure : 59 hPa, 20 °C
43 hPa, 20 °C
Density : ca. 0,99 g/cm3, 20 °C
Water solubility : 20 °C, in all proportions
Partition coefficient: n- : not applicable
octanol/water
Viscosity, dynamic : ca. 30 mPa*s, 20 °C, DIN 54453
Relative vapor density : no data available
Evaporation rate : no data available
9.2 Other information
None known.
10.1 Reactivity
No dangerous reaction known under conditions of normal use.
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Skin irritation
Cocosalkylpropylen- : rabbit, Result: Corrosive, OECD Test Guideline 404, 4 h
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Result: Corrosive
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : rabbit, Result: No skin irritation
Tridecylpolyethylenglycoleth- : rabbit, Result: No skin irritation
er
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Eye irritation
Cocosalkylpropylen- : rabbit, Result: Corrosive, OECD Test Guideline 405
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Result: Corrosive
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : rabbit, Result: Mild eye irritation
Tridecylpolyethylenglycoleth- : rabbit, Result: Risk of serious damage to eyes.
er
Propan-2-ol : Result: Irritating to eyes.
N-dodecylpropane-1,3- : Causes eye burns.
diamine
Sensitisation
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : guinea pig, Result: Did not cause sensitization on laboratory
pounds, benzyl-C12-16- animals.
alkyldimethyl, chlorides
Ethanol : Maximisation Test, guinea pig, Result: Did not cause sensiti-
zation on laboratory animals.
Tridecylpolyethylenglycoleth- : Maximisation Test, guinea pig, Result: Did not cause sensiti-
er zation on laboratory animals.
Propan-2-ol : Buehler Test, guinea pig, Result: Did not cause sensitization
on laboratory animals.
N-dodecylpropane-1,3- : no data available
diamine
Genotoxicity in vivo
Ethanol : Result: not mutagenic
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Mutagenicity
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Tests on bacterial or mammalian cell cultures did not show
pounds, benzyl-C12-16- mutagenic effects.
alkyldimethyl, chlorides
Ethanol : Tests on bacterial or mammalian cell cultures did not show
mutagenic effects.
Tridecylpolyethylenglycoleth- : Not mutagenic in Ames Test.
er
Propan-2-ol : Animal testing did not show any mutagenic effects.
N-dodecylpropane-1,3- : Not mutagenic in Ames Test.
diamine
Carcinogenicity
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Animal testing did not show any carcinogenic effects.
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : Did not show carcinogenic effects in animal experiments.
Tridecylpolyethylenglycoleth- : Did not show carcinogenic effects in animal experiments.
er
Propan-2-ol : Animal testing did not show any carcinogenic effects.
N-dodecylpropane-1,3- : no data available
diamine
Reproductive toxicity
Tridecylpolyethylenglycoleth- : rat, NOAEL: > 250 mg/kg, F1: > 250 mg/kg, F2: > 250 mg/kg
er
Reproductive toxicity
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Animal testing did not show any effects on fertility.
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : In animal testing, risk of impaired fertility was shown only after
administration of very high doses of this substance.
Tridecylpolyethylenglycoleth- : Based on available data, the classification criteria are not met.
er
Propan-2-ol : Animal testing did not show any effects on fertility.
N-dodecylpropane-1,3- : no data available
diamine
Teratogenicity
Ethanol : rat, Oral, NOAEL: 2.000 mg/kg
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Teratogenicity
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Did not show teratogenic effects in animal experiments.
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : Animal experiments showed mutagenic and teratogenic ef-
fects.
Tridecylpolyethylenglycoleth- : Based on available data, the classification criteria are not met.
er
Propan-2-ol : Ingestion of excessive amounts by pregnant animals resulted
in maternal and foetal toxicity.
N-dodecylpropane-1,3- : no data available
diamine
12.1 Toxicity
Toxicity to fish
Cocosalkylpropylen- : LC50: 0,1 - 1 mg/l, 96 h, Danio rerio (zebra fish)
diaminbiguanidinium-diacetat
Quaternary ammonium com- : LC50: 0,85 mg/l, 96 h
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : LC50: 8.140 mg/l, 48 h, Leuciscus idus (Golden orfe)
Tridecylpolyethylenglycoleth- : LC50: > 1 - 10 mg/l, 96 h, Cyprinus carpio (Carp), OECD Test
er Guideline 203
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Propan-2-ol : LC50: > 100 mg/l, 48 h, Leuciscus idus, static test, Raw mate-
rial
N-dodecylpropane-1,3- : LC50: > 0,1 - 0,35 mg/l, 96 h, Danio rerio (zebra fish), OECD
diamine Test Guideline 203
Toxicity to daphnia and other : EC50: 0,28 mg/l, 48 h, Daphnia magna (Water flea), Analytical
aquatic invertebrates monitoring: yes, OECD Test Guideline 202, GLP: yes
Toxicity to algae
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : IC50: 0,03 mg/l, 72 h
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : IC50: > 100 mg/l, 72 h, Scenedesmus quadricauda (Green
algae)
Tridecylpolyethylenglycoleth- : EC50: 72 h, Desmodesmus subspicatus (green algae), OECD
er Test Guideline 201
Propan-2-ol : EC50: > 100 mg/l, 72 h, Desmodesmus subspicatus (green
algae), static test, Raw material
N-dodecylpropane-1,3- : not determined
diamine
Bioaccumulation
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : Does not bioaccumulate.
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : Bioaccumulation is unlikely.
Tridecylpolyethylenglycoleth- : Bioaccumulation is unlikely.
er
Propan-2-ol : No bioaccumulation is to be expected (log Pow <= 4).
N-dodecylpropane-1,3- : not determined
diamine
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Mobility
Cocosalkylpropylen- : no data available
diaminbiguanidinium-diacetat
Quaternary ammonium com- : no data available
pounds, benzyl-C12-16-
alkyldimethyl, chlorides
Ethanol : no data available
Tridecylpolyethylenglycoleth- : no data available
er
Propan-2-ol : Mobile in soils
N-dodecylpropane-1,3- : not determined
diamine
Waste key for the unused : European waste catalog (EWC) 070601
product
Waste key for the unused : Waste material of HZVA from fats, lubricants, soaps, deter-
product(Group) gents, disinfectants and personal protection products.
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
ADR/RID-Labels 8+N
ICAO-Labels 80
IMDG : UN number 1903
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Exempt
15.1 Safety, health and environmental regulations/legislation specific for the substance or mix-
ture
Legislation on the control of : Directive 96/82/EC does not apply
major-accident hazards in-
volving dangerous substanc-
es
Other regulations : The surfactant(s) contained in this mixture complies(comply)
with the biodegradability criteria as laid down in Regulation
(EC) No.648/2004 on detergents. Data to support this asser-
tion are held at the disposal of the competent authorities of the
Member States and will be made available to them, at their
direct request or at the request of a detergent manufacturer.
Gigasept Instru AF
Version 03.01 Revision Date 01.02.2013 Print Date 12.03.2013
Further information
The information provided in this Safety Data Sheet is correct to the best of our knowledge, in-
formation and belief at the date of its publication. The information given is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release and
is not to be considered a warranty or quality specification. The information relates only to the
specific material designated and may not be valid for such material used in combination with
any other materials or in any process, unless specified in the text.