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EC number: 202-414-9 | CAS number: 95-38-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Not skin-sensitising to guinea pigs
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 09 Feb 1981 to 02 Mar 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- difference in exposure details
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Maurer optimisation test has been carried out as an animal test to predict human sensitization. This test is similar to the OECD recommended Guinea Pig Maximization Test (GPMT).
- Specific details on test material used for the study:
- The substance contains 2% active ingredient
- Name of test material (as cited in study report): 81'004/B
- Lot/batch No.: Hu 139/1
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 10 weeks
- Weight at study initiation: 260 - 410 g
- Housing: individually in Macrolon cages type 3
- Diet: Standard guinea pig pellets - NAFAG No. 830, Gossau SG, ad libitum
- Water: Ad libitum
- Acclimation period:10 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1° C
- Humidity: 50 +/- 10%
- Photoperiod: 14 hours light cycle - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline PhH VI
- Concentration / amount:
- 30% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Day(s)/duration:
- 48 h
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline PhH VI
- Concentration / amount:
- 30% test substance solution dissolved in vehicle (test substance solution contains 2% active ingredient)
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: three weeks
- Test groups: During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1% solution of the test article (containing 2% of the active ingredient) in physiological saline. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1).
- Control group: One control group was treated with the vehicle alone.
- Site: On the first day, injections of 0.1 mL were administered into the shaved skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
- Concentrations: 0.1% of a 2% solution, i.e. 0.002%
B. CHALLENGE EXPOSURE
- No. of exposures: two (injection and epicutaneous application)
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1% solution of the test article (containing 2% of the active ingredient) in physiological saline was administered into the skin of the left flank. 24 hours after the challenge injection the reactions were recorded. Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (30% test material, containing 2% active ingredient, in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 hours after removing of the bandages according the Draize scoring scale. - Positive control substance(s):
- not specified
- Positive control results:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.002%, intradermal (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 0.1% test article, containing 2% active ingredient, equals 0.002% active ingredient
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.002%, intradermal (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 0.1% test article, containing 2% active ingredient, equals 0.002% active ingredient
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.6%, epicutaneous (active ingredient)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: 30% test article, containing 2% active ingredient, equals 0.6% active ingredient
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.6%, epicutaneous (active ingredient)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 30% test article, containing 2% active ingredient, equals 0.6% active ingredient
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Because the substance is considered to be corrosive to the skin, no standard skin sensitisation study needs to be performed. However, the substance has been tested at concentrations in which the substance is not considered corrosive and in that study no skin sensitisation was observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be not classified for sensitisation in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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