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EC number: 251-118-6 | CAS number: 32588-76-4
- 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
In skin and eye irritation studies in rabbits no indication of irritation was observed.
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
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- Each of six adult (3 each M/F) New Zealand White rabbits were administered the test article and four skin sites – two abraded and two intact. Application sites were shaved. The skin was abraded using a 21-gauage burred needle; the abrasion penetrated the stratum corneum but not the dermis. Following the application of test material, one-inch square gauze patches were applied to each of the four sites. The animal’s trunk was then wrapped with a rubber dam and an Ace bandage to retard evaporation. The test substance was kept in contact with the skin site for 24 hrs. At the end of exposure, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and scored according to the Draize scale at 24 and 72 hrs after the test article was applied.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Saytex 42-77, Lot BR-3
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Individually caged. Light cycle: 12 hrs light, 12 hrs dark. Room temperature was 20 +/- 3 degrees C. Humidity was 30-70%.Annual testing of drinking water by Pennsylvania Gas and Water Company. Rabbits were fed Wayn Rabbit Ration ad libitum.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped & one side abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- o.5 mL/site
- Duration of treatment / exposure:
- 24 hr
- Observation period:
- 24 and 72 hr post-treatment
- Number of animals:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: All
- Score:
- 0.71
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- EBTBP was mildly irritating to the skin of rabbits.
- Executive summary:
EBTBP (500 mg) was applied to the clipped abraded and intact skin of 6 albino rabbits. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr and the test site scored by the Draize method. The test site was also scored at 72 post-treatment. The test substance was considered to be a mild skin irritant.
Reference
Rabbit Number |
Sex |
Weight (kg) |
Observed Effects |
||||||||
24 Hours |
72 Hours |
||||||||||
Erythema |
Edema |
Erythema |
Edema |
||||||||
Initial |
Final |
Intact |
Abraded |
Intact |
Abraded |
Intact |
Abraded |
Intact |
Abraded |
||
2744 2745 2746 2747 2748 2749 |
M |
2.796 2.744 2.749 2.184 2.276 2.221 |
2.889 2.467 2.836 2.288 2.427 2.409 |
1-1 1-2 0-0 0-0 0-0 0-0 |
2-2 1-2 0-0 0-0 0-1 0-0 |
1-1 1-1 1-1 1-1 0-0 1-1 |
1-1 1-1 1-1 1-1 0-0 1-1 |
0-0 - 0-0 0-0 0-0 0-0 |
0-0 - 0-0 0-0 0-0 0-0 |
0-0 - 0-0 0-0 0-0 0-0 |
0-0 - 0-0 0-0 0-0 0-0 |
Totals |
2-4 |
3-5 |
5-5 |
5-5 |
0-0 |
0-0 |
0-0 |
0-0 |
|||
Mean Values Erythema/Edema |
1.0 |
1.3 |
1.7 |
1.7 |
0.0 |
0.0 |
0.0 |
0.0 |
|||
Total Erythema/Edema |
2.3 |
3.4 |
0.0 |
0.0 |
|||||||
Primary Irritation Index (Total/8) |
0.71 |
0.0 |
One rabbit died on study (non-compound related).
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
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, U.S. Federal Register, 38(187)P 27019, 27 Sept 1973
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Principles of method if other than guideline:
- 0.1 g instilled in one eye of each of 6 rabbits. test material not washed from eye. observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as own control
- Amount / concentration applied:
- 0.1 gm in one eye of each rabbit
- Duration of treatment / exposure:
- test material not washed from eye
- Observation period (in vivo):
- observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: all scores at all time points were 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- EBTBP is not an eye irritatnt.
- Executive summary:
EBTBP (100 mg) was instilled in the right eye of six albino rabbits. The treated eyes were observed at 1, 24, 48 and 72 hours and 5 and 7 days post treatment. No effects were observed at any time point in any animal with respect to the cornea, iris, or conjunctiva. The test article was not an eye irritant.
Reference
Eyes observed for corneal opacity, iris, conjunctival redness and chemosis, and discharge.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The substance did not induce skin or eye irritation in standard studies in rabbits. It is unlikely from these results that the substance is an respiratory irritant. The acute inhalation study did not show any signs of irritation to the respiratory tract.
Justification for selection of skin irritation / corrosion endpoint:
The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Justification for selection of eye irritation endpoint:
The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Justification for classification or non-classification
Due to the absence of skin and eye irritation in standard studies in rabbits, the substance is not classified for these endpoints.
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