Registration Dossier
Registration Dossier
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EC number: 227-217-5 | CAS number: 5718-26-3
Endpoint summary
Administrative data
Description of key information
In an in vivo dermal irritation study according to OECD TG 404 no erythema or edema were observed at any time point (1h to 14 days) after exposure to 500 mg to the skin.
In an in vivo eye irritation study according to OECD TG 405 no effects (cornea, iris, and conjunctivae) were observed at any time point (1h to 21 days) after exposure to 100 mg in the eyes of 3 rabbits.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Macrolex orange 51032 (Code Nr.: 826-152)
Solid powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 3 rabbits were used. Body weight approx. 2.9 kg, temperature 19-25 degree Celsius, 12/12 h dark/light rythm.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 female rabbits
- Irritation parameter:
- erythema score
- Basis:
- other: animal 1, 2 and 3
- Time point:
- other: 1, 24,48,72 h, 7 and 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within:
- Remarks on result:
- no indication of irritation
- Remarks:
- due to the color of the substance erythema scoring was not possible for the first 4 time points.
- Irritation parameter:
- edema score
- Basis:
- other: animal 1, 2 and 3
- Time point:
- other: 1, 24,48, 72 h, 7 and 14 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within:
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an in vivo dermal irritation study according to OECD TG 404 no erythema or edema were observed at any time point (1h to 14 days) after exposure to 500 mg to the skin.
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:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Macrolex Orange 51032 (Codenr.: 826-152)
solid powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 3 female; average weight: 3 kg; temperature 19-25 degree Celsius; air humidity 40-60%; 12h/12h light / dark per day.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 female rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 1, 2 and 3
- Time point:
- other: 1, 24, 48, 72 h, 7, 14 and 21 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an in vivo eye irritation study according to OECD TG 405 no effects (cornea, iris, and conjunctivae) were observed at any time point (1h to 21 days) after exposure to 100 mg in the eyes of 3 rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No irritationg effects were observed in guideline in vivo skin and eye irritation studies.
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