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EC number: 293-165-5 | CAS number: 91052-08-3
- 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
Skin irritation / corrosion
Administrative data
- 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (Limited details on materials and methods, and results, no test substance volume.)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited information on materials and methods, males only were dosed, no individual animal data, no necropsy, limited observation period.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted Feb 1987
- Deviations:
- yes
- Remarks:
- Limited information on materials and methods, mouse species, limited observation period, males only were dosed, no individual animal data, no necropsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- other: SPF NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 19 - 20 g - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6 days
- Frequency of observations and weighing: the animals were observed for mortality and morbidity, and the body weight was recorded; the frequency was not reported
- Necropsy of survivors performed: no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study period.
- Clinical signs:
- No adverse clinical signs were reported.
- Body weight:
- The body weight growth was reported to be "normal".
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The observation period was only 6 days. However, as no clinical signs were observed and the body weight development was described to be normal, it is unlikely that mortality would have occurred in the time period Day 7-14. The study is therefore considered to be sufficient to meet the data requirement and the LD50 is considered to be > 2000 mg/kg bw.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (Limited details on materials and methods, no anaesthetics were used, unknown test substance volume.)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adpoted Oct 2012
- Deviations:
- yes
- Remarks:
- Limited details on materials and methods, test substance volume, no anaesthetics were used.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 (sex not specified)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- At the 1-h reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point (the score was reduced in 2/3 animals at this time point). The conjunctivae persisted in 1/3 animals until 48 h after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 h after treatment. 2/3 animals showed chemosis at the 1-h reading time point; the chemosis had cleared completely within 24 h after treatment. No effects were repoted on the cornea or iris in any animal at any reading time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 405, which specifies that a volume of 0.1 mL should be used. The result of the study is therefore considered to be acceptable.
Table 1. Individual eye irritation scores
Rabbit #
|
Time
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 h |
2 |
0 |
0 |
0 |
24 h |
2 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
1.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 h |
2 |
1 |
1 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.33 |
0.0 |
0.0 |
0.0 |
|
3
|
1 h |
3 |
1 |
0 |
0 |
24 h |
2 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.67 |
0.0 |
0.0 |
0.0 |
*(24h+48h+72h)/3
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- yes
- Remarks:
- Limited details on materials and methods, and results; no test substance volume.
- GLP compliance:
- no
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Observation period:
- 72 h
- Number of animals:
- 3 (sex not specified)
- Details on study design:
- OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 3/3 animals showed mild erythema (score 1) at the 1-h reading time point, which persisted in 1/3 animals until the 24-h reading time point. All effects had cleared within 48 h after patch removal. No oedema was observed in any animal at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 404, which specifies that a volume of 0.5 mL should be used. The result of the study is therefore considered to be acceptable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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