Registration Dossier
Registration Dossier
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EC number: 604-269-0 | CAS number: 14205-46-0
Endpoint summary
Administrative data
Description of key information
Skin irritation in vivo (rabbit, GLP, OECD TG 404): slightly irritating to the skin
Eye irritation in vivo (Rabbit, GLP, OECD TG 405): irritating to the eye
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: non-treated conlateral skin areas served as control
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours up to 7 days
- Number of animals:
- 3 females
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days after treatment
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after treatment
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h after treatment
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after treatment
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Executive summary:
In a skin irritation study performed according to OECD TG 404 the test substance showed to be slightly irritating to the skin of rabbits. Erythema grade 1 was seen in animal 1 (24h to 72h), animal 2 (24h), and animal 3 (24h to 48h). Slight oedema (grade 1) occured only in animal 1 24h after treatment.
Reference
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- single insillation
- Observation period (in vivo):
- 1, 24, 48, 72 h up to 7 days
- Number of animals or in vitro replicates:
- 3 females
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: fluorescein staining grade 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: fluorescein staining: grade 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: fluorescein staining: grade 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- other: 24, 48, 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #3
- Time point:
- other: 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- lacrimation became obvious
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Executive summary:
In an eye irritation study performed according to OECD TG 405 the test substance showed to be irritating to the eyes of rabbits. Effects on cornea (grade 1 and 2), and conjunctivae (grade 1 and 2) as well as increased lacrimation became obvious. The effects were shown to be reversible within the 7 day observation period.
Reference
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a skin irritation study performed according to OECD TG 404 the test substance showed to be slightly irritating to the skin of rabbits. Erythema grade 1 was seen in animal 1 (24h to 72h), animal 2 (24h), and animal 3 (24h to 48h). Slight oedema (grade 1) occured only in animal 1 24h after treatment.
In an eye irritation study performed according to OECD TG 405 the test substance showed to be irritating to the eyes of rabbits. Effects on cornea (grade 1 and 2), and conjunctivae (grade 1 and 2) as well as increased lacrimation became obvious. The effects were shown to be reversible within the 7 day observation period.
Justification for selection of skin irritation / corrosion endpoint:
only one study available
Justification for selection of eye irritation endpoint:
only one study available
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Based on the study results a classification with R 36 (irritating to eyes) according to Directive 67/548/EEC and with Eye Irritant Class 2 (causes serious eye irritation) according to Regulation (EC) No. 1272/2008 (CLP) is warranted.
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