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EC number: 275-174-6 | CAS number: 71077-31-1
- 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
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:
- 1 November 1982 - 5 December 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability 2 is assigned because the study conducted similar to OECD TG 406 (GPMT), without GLP and with minor deviations that do not influence the quality of the results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire
- Age at acclimatization start: 4-6 weeks
- Weight at acclimatization start: 310-417 g
- Housing: suspended cages with wire mesh floors
- Diet: free access to Vitamin C-enriched guinea pig diet (Special Diets Services Limited)
- Water: free access to tap water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS (check details)
- Temperature (°C): +/- 21
- Humidity (%): 30-70
- Air changes (per hr): +/- 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- - 5% (v/v) for the intradermal induction
- Undiluted (100%) for the epidermal induction
- 1%, 5%, 10% and 20% (v/v) for the challenge - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- - 5% (v/v) for the intradermal induction
- Undiluted (100%) for the epidermal induction
- 1%, 5%, 10% and 20% (v/v) for the challenge - No. of animals per dose:
- Test animals: 15
Control animals: 15 - Details on study design:
- RANGE FINDING TESTS
Intradermal and topical irritancy of a range of dilutions of the test substance in liquid paraffin was investigated to identify irritant test substance concentrations suitable for the induction phase of the main study. A range of non-irritant concentrations was selected for the challenge phase following consultation with the Sponsor.
MAIN STUDY
A. INDUCTION EXPOSURE
1) Intradermal injections
- Concentration: 5%
- Site: the dorsal scapular region (clipped free of hair)
Test group (three pairs of 0.1 mL intradermal injections):
1) Freund's complete adjuvant (FCA) 50:50 with water
2) Test substance at 5% (v/v) in vehicle
3) Test substance at 5% (v/v) in a 50:50 mixture of FCA with vehicle
Control group (three pairs of 0.1 mL intradermal injections):
1) Freund's complete adjuvant (FCA) 50:50 with water
2) Vehicle
3) 50:50 mixture of FCA with vehicle
2) Topical applications one week after the injections:
- Site: the dorsal scapular region (clipped and shaved free of hair)
- Concentration: test animals undiluted test article (100%), control animals no data (page missing in report)
- Amount: saturated patch
- Area: 8 cm2
- Exposure period: 48 hours (occlusive)
B. CHALLENGE EXPOSURE (control and test group)
- Concentrations: 1%, 5%, 10% and 20%
- Evaluation: 24, 48 and 72 hours after start of challenge
- Other information on challenge exposure: no data (page missing in report) - Positive control substance(s):
- no
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: test group. Dose level: 5%. No with. + reactions: 8.0. Total no. in groups: 15.0.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- Result in one animal was inconclusive
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: test group. Dose level: 10%. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: Result in one animal was inconclusive.
- Reading:
- other: 24, 48 and 72 hours after challenge
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 12
- Total no. in group:
- 14
- Clinical observations:
- Result in one animal was inconclusive, one animal was excluded
- Remarks on result:
- other: Reading: other: 24, 48 and 72 hours after challenge. Group: test group. Dose level: 20%. No with. + reactions: 12.0. Total no. in groups: 14.0. Clinical observations: Result in one animal was inconclusive, one animal was excluded.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, performed in accordance with a method similar to OECD 406, it was observed that skin sensitisation occurred in >30% of the test animals at tested concentrations at and above 5%, but not at 1%. Based on these results, the test substance can be considered a skin sensitiser.
- Executive summary:
The skin sensitisation potential of the substance was investigated by performing a guinea pig maximisation test performed in accordance with a method similar to OECD 406 (GPMT), but there is no indication of GLP compliance. A concentration of 5% was used for the intradermal induction, 100% (undiluted test article) for the epidermal induction and 1%, 5%, 10% and 20% for the challenge. In the 1% test group none of the fifteen animals showed a sensitisation response. In the groups exposed to 5%, 10% and 20% of the test sample, 8/15 animals (53%), 7/15 animals (47%) and 8/14 animals (86%) showed a positive response, respectively. Based on these results the substance is considered to be a skin sensitiser as >30% of the animals showed sensitisation at these concentrations.
Reference
Results of the three readings (24, 48 and 72 hours after start of challenge) are summarized per challenge concentration. From one guinea-pig the patch was lost during the 4th challenge (20% test substance) application. No scores were therefore recorded for this animal on this occasion.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
The skin sensitisation potential of the substance was investigated by performing a guinea pig maximisation test performed in accordance with a method similar to OECD 406, but there is no indication of GLP compliance. A concentration of 5% was used for the intradermal induction, 100% (undiluted test article) for the epidermal induction and 1%, 5%, 10% and 20% for the challenge. In the 1% test group none of the fifteen animals showed a sensitisation response. In the groups exposed to 5%, 10% and 20% of the test sample, 8/15 animals (53%), 7/15 animals (47%) and 8/14 animals (86%) showed a positive response, respectively. Based on these results the substance is considered to be a skin sensitiser as >30% of the animals showed sensitisation at these concentrations.
Justification for selection of skin sensitisation endpoint:
The result of this study is sufficiently reliable and sufficiently adequate for covering this endpoint.
Justification for classification or non-classification
According to the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP), the substance needs to be classified as a skin sensitizer (Skin Sens. 1B, H317) as at an intradermal induction concentration of 5% (the highest concentration tested) more than 30% response were seen at the challenge phase.
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