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EC number: 202-908-4 | CAS number: 101-02-0
- 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
Skin sensitization: Sensitizing in GPMT (m/f); guinea pig, according to OECD TG 406, GLP, K1
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:
- key study
- Study period:
- January 23, 1995 - February 16, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not established yet by the time the study was conducted.
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:CIBA-GEIGY Limited, Animal Production
- Weight at study initiation: between 329 to 425 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: d libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Oleum arachidis (intradermal), vaseline (epidermal)
- Concentration / amount:
- intradermal: 5%
epidermal: 20% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis (intradermal), vaseline (epidermal)
- Concentration / amount:
- 10%
- No. of animals per dose:
- 10 (test group)
5 (control group) - Details on study design:
- RANGE FINDING TESTS:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. Since 5% in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction. The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations have been examined on separate animals for the determination of the maximum subirritant concentration: 10 and 20% in vaseline. 20% was the highest possible concentration of the test article in vaseline. Reactions were observed with 20% in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
Three pairs of intradermal 0.1 ml injections (adjuvant/saline mixture 1:1 (v/v); 5% test article in Oleum arachidis (w/v); 5% test article in the adjuvant/saline mixture (w/v)) were made simultaneously into the left and right side of the shaved neck of the test and control group animals. The control group received the same injections without the test article. Eight days after the intradermal induction, the test article was incorporated in vaseline (w/w; 20%) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only.
B. CHALLENGE EXPOSURE
Two weeks later, the test and control group animals were tested on one flank with the test article in vaseline (w/w; 10%) and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours). Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser. The results of the last control with 2-Mercaptobenzothiazole is included in the report.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the experimental conditions employed, 90% and 95% of the animals of the test group were sensitised 24 and 48 hours after removing the dressings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitisation (GPMT)
For the assessment of possible skin sensitizing properties of the test substance, a GPMT was conducted (K1, GLP, OECD 406; BASF, 1995) in Pirbright White guinea pigs by intradermal (5% test substance) and epicutaneous (20% test substance) induction, with subsequent epicutaneous challenge with 10% test substance. Ten animals/sex were used in the test group and 5 in the control group.
Under the experimental conditions employed, 90% and 95% of the animals of the test group were sensitised 24 and 48 hours after removing the dressings. No sensitizing effects were observed in the control group.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Positive responses (90 – 95 %) were observed in a guinea pig maximization test (OECD 406) after an intradermal induction with 5 % test substance. Since the induction concentration was greater than 1 %, the substance is considered to be classified as a skin sensitizer of moderate potency (Cat. 1B) under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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