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EC number: 202-409-1 | CAS number: 95-31-8
- 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
The test substance TBBS showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1982). The even very low skin irritation potential is confirmed by two additional skin irritation studies (Monsanto Co. 1973, 1982b). A rather slight and transient eye irritation potential is noted in an eye irritation study (Monsanto Co. 1973).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and comparable to guideline study with acceptable restrictions (e.g. no observation time point at 48 h post-treatment)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no 48 h observation time point, 24 h exposure time, intact and abraded skin tested
- Principles of method if other than guideline:
- The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits. The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6 (3 males, 3 females)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not determined
- Remarks on result:
- other:
- Remarks:
- score not determined at 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin sites
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin sites
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not determined
- Remarks on result:
- other:
- Remarks:
- score not determined at 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: intact skin sites
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment.
- Executive summary:
The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits (Monsanto Co. 1982). The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.
Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.
Reference
Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.
Total Draize score: 0.1
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited but acceptable documented study report which meets basic scientific principles
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6 animals
- Irritation parameter:
- other: Draize score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (conjunctiva + chemosis + discharge) x 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: (conjunctiva + chemosis + discharge) x 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- GHS criteria not met
- Executive summary:
100 mg of finely ground Santocure NS vulcanization accelerator was placed into the conjunctivial sac of 6 New Zealand albino male and female rabbits. A 7-d observation period followed application. Eye responses were scored in accordance with the Federal Hazardous Substances Act, 21 CFR, § 191.12 (1964).
The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.
Reference
The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.
EU mean chemosis score: 0
EU mean corneal score: 0
EU mean iritis score: 0
Draize score: 2.5/110
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits (Monsanto Co. 1982). The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. The test substance TBBS was practically non-irritating to rabbit skin (mean erythema and edema score intact skin: 0).
This finding is confirmed by two other skin irritation studies, which also indicated a very low skin irritation potential of the test substance (Monsanto Co. 1973, 1982b).
Eye
The eye irritating potential of the test substance TBBS was evaluated in an eye irritation study with New Zealand albino male and female rabbits (Monsanto Co 1973). 100 mg of the finely ground test substance was placed into the conjunctival sac of six male and female rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).
The test substance was slightly irritating to the rabbit eye (irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.
Justification for selection of skin irritation / corrosion
endpoint:
GLP and comparable to guideline study with acceptable restrictions
(e.g. no observation time point at 48 h post-treatment).
Justification for selection of eye irritation endpoint:
Limited but acceptable documented study report which meets basic
scientific principles.
Justification for classification or non-classification
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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