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EC number: 239-263-3 | CAS number: 15206-55-0
- 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
Guideline studies conducted prior to GLP requirements.
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:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, §1500.41, S. 27029
- Version / remarks:
- 1973
- Deviations:
- yes
- Remarks:
- Exposure period extended to 24 hours, no scoring at 48 hour observation, and observation period shortened to 8 days.
- Principles of method if other than guideline:
- 2 animals were tested applying the test substance for 5 min and 2 hours under occlusive conditions, respectively. The test substance was rinsed with Lutrol and observed after 24, 48 hours and 8 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: female: 3.44 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 5min, 2h or 24 hours
- Observation period:
- 24, 72 hours and 8 days
- Number of animals:
- 3 (24h exposures)
2 (5min and 2h exposure) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- other: 24, 72 hours
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- other: 24, 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- other: 24, 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- other: 24, 72 hours
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- other: 24h, 72 hours
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- other: 24, 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin (2h exposure), 48h reading was not taken due to study design and age of the study.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 4
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 4
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 5
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 5
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.
- Other effects:
- Scaling was found in all animals on day 8 of observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material achieved mean erythema scores in 2 of 3 test animals of 2.5 each after a 24 hour occlusive exposure. After a 2 hour expsoure the test material achieved a mean erythema score of 0.5 in both animals tested, fully reversible within 8 days. Due to the non-standard exposure period, the test material is considered not to fulfill the criteria for skin irritation under EU regulation 12772/2008.
- Executive summary:
In this guideline study (Federal Register 38, No. 187, §1500.41, S. 27029; 1973) the test material was tested twice with exposure times of 24 hours and 2 hours. After the 24 hour exposure period, the test material achieved mean erythema scores in 2 of 3 animals of 2.5 each. After the 2 hour exposure, the test material achieved a mean erythema scores in both test animals of 0.5, reversible in 8 days. As the standard exposure period is 4 hours, the test material is considered not to meet the criteria cor skin irritation classificaiton according to EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
Reference
Results for 24h exposure:
|
reading time |
animal 1 |
animal 2 |
animal 3 |
erythema |
|
|
|
|
intact skin |
24h |
2 |
2 |
2 |
|
72h |
3 |
2 |
3 |
|
8d |
2 S |
0 S |
2 S o |
|
mean 24,72h |
2.5 |
2 |
2.5 |
abraded skin |
24 h |
3 |
3 |
2 |
|
72h |
3 |
3 |
3 o |
|
8d |
2 S |
1 S |
2 sS o |
|
mean 24,72h |
3 |
3 |
2.5 |
edema |
|
|
|
|
intact skin |
24 h |
2 |
0 |
2 |
|
72h |
2 |
1 |
2 |
|
8d |
0 |
0 |
0 |
|
mean 24,72h |
2 |
0.5 |
2 |
abraded skin |
24 h |
2 |
2 |
2 |
|
72h |
3 |
3 |
3 o |
|
8d |
0 |
0 |
0 |
|
mean 24,72h |
2.5 |
2.5 |
2.5 |
S: scaling; sS: strong scaling; overall
Results for internal method: After 2 hour exposure with the test substance to the skin of two rabbits erythema of score 1 was observed 24 hours later. This effect was fully reversible within 48 hours (score 0). 8 days after application scaling was still observed. No edema was observed at any reading time point.
Exposure Time | Animal No. | 1. Redness - Corossion | 2. Oedema | ||||
24 hrs | 48 hrs | 8 Days | 24 hrs | 48 hrs | 8 Days | ||
2 hrs | 1 | 1 | 0 | 0 S | 0 | 0 | 0 |
2 | 1 | 0 | 0 S | 0 | 0 | 0 |
S = scaling
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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, §1500.41, S. 27019 vom 27.09.73
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 72h observation period only (acceptable, as very mild findings only)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 3.0 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours not washed out
- Observation period (in vivo):
- 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not provoke an irritating response in the test model. The test material does not fulfill the criteria for classification and labelling according to EU regulation 1272/2008.
- Executive summary:
In this guideline (Federal Register 38, No. 187, §1500.41, S. 27019) study conducted prior to GLP adoption, the test material (EC 239-263-3), was found to be non-irritating to the rabbit eye. The test was conducted in three female rabbits. The test material did not fulfill the criteria for classification as an eye irritant according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
Reference
Results:
|
|
|
|
Conjunctivae |
|
animal |
time after application |
cornea |
iris |
Redness |
Chemosis |
1 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
|
2 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
3 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
|
1 |
mean 24-72 h |
0.0 |
0.0 |
1.0 |
0.0 |
2 |
0.0 |
0.0 |
0.7 |
0.0 |
|
3 |
0.0 |
0.0 |
1.0 |
0.0 |
|
mean 24-72h |
0.0 |
0.0 |
0.9 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Assessment of skin irritating properties is derived from effects observed at 2h or 24 h exposure. Whereas the EU classification system is based on effects observed after 4h semi-occlusive exposure, data is only available for 2h or 24h exposure for occlusive conditions.
Effects observed at 2h a clearly below the threshold for classification, whereas the erythema finding for the 24h exposure are above the classification threshold in the 24 -72h mean. It is considered that the values obtained for 4h semi-occlusive exposure would be in the non-irritating range. This is supported by secondary information on data from Bayer AG is summarized in the ECB IUCLID document (23-OCT-95)
Eye irritation:
Installation of the test item into eyes caused mild conjunctival irritation which did not resolved within 72h. All effects observed are below the threshold of regulation and the substance is therefore not considered to be irritating to eyes. This is supported by secondary information on data from Bayer AG is summarized in the ECB IUCLID document (23-OCT-95)
Justification for classification or non-classification
Skin irritation:
Given the non-standard exposure durations used in the key study (2 hours and 24 hours), a review of both test results was undertaken to assess the substance for skin irritation under the criteria of the EU Classificaiton, Labelling, and Packaging (CLP) regulation (1272/2008).
Average Erythema and Oedema scores over 72 hour exposure period for each test animal:
Test animal | 2 hour exposure test | 24 hour exposure test | ||
Erythema | Oedema | Erythema | Oedema | |
1 | 0.5 | 0 | 2.5 | 2 |
2 | 0.5 | 0 | 2 | 0.5 |
3 | - | - | 2.5 | 2 |
Although the results from the 24 hour classification meet the criteria for classification as a skin irritant, because the exposure period is 6 times longer than that indicated in the CLP regulation use of the result for classificaiton and labelling was considered to be overly conservative. As the 2 hour exposure test is only half the recommended exposure time, it is the registrants decision to use a range between the two tests. A average score range of 1 -2 across all three animals was considered by the registrant to be suitable for classificaiton and labelling. Based upon this range the substance does not meet the criteria of the EU CLP regulation for classification as a skin irritant.
Eye irritation:
Based upon the result of the key study, the substance does not meet the criteria of the EU CLP regulation for classification as an eye irritant.
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