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EC number: 300-340-2 | CAS number: 93925-38-3
- 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 irritation: Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.
Eye irritation: No effects were observed in any animal at any observation period.
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:
- 7/12/82 to 7/23/82
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP conducted according to guideline 16 CFR Section 1500.41 of the Federal Hazardous Substances Act Regulations
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR Section 1500.41
- Principles of method if other than guideline:
- The method employed in the testing, evaluations and the soring was similar to that described in Section 1500.41-Federal Hazardous Substances Act Regulations -16 CFR.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3Temperatuire - 70°F (+- 2°F)Relative Humidity 45% (+-5%)Light: 12 hour light/dark cycleDiet - Wayne 15 % Rabbit Ration and tap water were provided ad libitum.Caging: Stainless steel with elevated wire mesh flooring. 1 rabbit/cageBedding: Deotized Animal Cage Board (DACB). Sheperd Products Company. Kalamazoo, Michigan 49005
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One site of the animal's treated on abraded zone, and the other side remained intact
- Amount / concentration applied:
- A 0.5 ml portion of material was applied to an abraded and an intact site on the same rabbit.
- Duration of treatment / exposure:
- The wrapping was removed at the end of the 24 hour period.
- Observation period:
- Treated areas were examined directly after the removal and readings were also made 72 hours after.
- Number of animals:
- A group of 6 rabbits were clipped
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.083
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See Table
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin irritant in rabbits.In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance is not required for dermal irritation.
- Executive summary:
Test Guidance
Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.Method and Material
Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Results
Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
Reference
Erythema and eschar formation
|
Edema Formation
|
Primary irritation Score: 0.34/4=0.09
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:
- 7/12/82 to 9/16/82
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP conducted according to guideline 16 CFR Section 1500.42 of the Federal Hazardous Substances Act Regulations
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR- Federal Hazardous Substances Act Regulations- Section 1500.42
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3Temperatuire - 70°F (± 2°F)Relative Humidity 45% (± 5%)Light: 12 hour light/dark cycleDiet - Wayne 15 % Rabbit Ration and tap water were provided ad libitum.Caging: Stainless steel with elevated wire mesh flooring. 1 rabbit/cageBedding: Deotized Animal Cage Board (DACB). Sheperd Products Company. Kalamazoo, Michigan 49005
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Test material instilled in the right eye while the left eye served as control
- Amount / concentration applied:
- 0.1 ml of the experimental material
- Duration of treatment / exposure:
- Material was not washed from the eyes
- Observation period (in vivo):
- The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes
- Number of animals or in vitro replicates:
- Six healthy young adult new zealand White rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): NoSCORING SYSTEM: Draize method
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritant effects were noted at any timepoint in the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no irritant effects in the eye of rabbits.In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation..
- Executive summary:
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No effects were observed in any animal at any observation period.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
Reference
All the individual daily scores for all the rabbits are 0. That means:
No Opacity of Cornea for all the animals, for all records.
Normal irises for all the animals, for all records.
Neither chemosis nor redness of the conjuntivaes for all the animals, for all records.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Dermal
Test Guidance
Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.
Method and Material
Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Results
Only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
Eye
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.
Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No effects were observed in any animal at any observation period.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
Justification for classification or non-classification
In accordance with the CLP Regulation, No 1272/2008, a substance should be classified as a skin irritant if:
- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
- Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
- In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
In the skin irritation study, only one rabbit exhibited very slight erythema at the 24 hour observation. There was no other irritation effect noted in any other rabbits at the 24 hour observation and all rabbits appeared normal at the 72 hour observation. All observed effects were reversed by the 72 -hour observation. As such, the test item does not meet the classification criteria.
In accordance with the CLP Regulation, No 1272/2008, a substance should be classified as a eye irritant if, for reversible effects:
if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
In the eye irritation study, no effects were observed in any animal at any observation period. Therefore, the test item does not meet the classification criteria.
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