Registration Dossier
Registration Dossier
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EC number: 201-186-8 | CAS number: 79-21-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Peracetic acid
- EC Number:
- 201-186-8
- EC Name:
- Peracetic acid
- Cas Number:
- 79-21-0
- Molecular formula:
- C2H4O3
- IUPAC Name:
- Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Strain: New Zealand White
- Sex: male
- Source: HSD/CPB, Zeist, The Netherlands
- Weight at study initiation: 2.5 - 3.0 kg
- Number of animals: 3 (1 per test compound)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped free of hair
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Area of exposure: test material was introduced under a 6 cm^2 gauze patch covered by aluminium foil secured by adhesive tape
- Concentration in vehicle: all products were used undiluted, therefore the peracetic acid concentrations were 40 % (Proxitane 4002), 15 % (Proxitane 1507) and 5 % (Proxitane 0512)
- Total volume applied: 0.5 mL
- Removal of test substance: yes, after four hours of exposure the patches were removed and the skin was wiped - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days postexposure
- Number of animals:
- 3
- Details on study design:
- Examinations: The resulting skin reactions were evaluated at 30-60 minutes and 24, 48 and 72 hours after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- No individual scores given, but general assessment of irritation available. Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
- Irritant / corrosive response data:
- Effects found were discolouration, edema, brown crust. The degree of damage between the 3 formulations was comparable.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- All three substances are considered to be corrosive to the rabbit skin.
Classification: corrosive (causes burns) - Executive summary:
In order to study the irritating/corrosive effects of three peracetic acid containing formulations (Proxitane 0512, Proxitane 1507 and Proxitane 4002) to the skin, 3 rabbits were dermally treated with the test materials. Because of the expected skin damaging properties only 1 animal per test material was used. Samples of 0.5 mL were applied on the shaven non-abraded skin of male rabbits and occluded under patches for 4 hours. 30 minutes after application the occlusion was temporarily removed treated and skin areas were examined. After removing the patches, scoring of the oedema and erythema was made at 30-60 minutes and 24, 48 and 72 hours after removal. The animals were observed until day 14 after application.
30 minutes after application (while the patches were still in place) the skin was oedematous and had turned white in each animal. Half an hour after removing the patches, there was a hard dry crusty white/yellow area observed at the areas treated with Proxitane 1507 and Proxitane 4002 which persisted until day 14 of the study, although it slowly turned brown. The animal that was treated with Proxitane 0512 showed a weak large white oedematous area at 30 minutes after removing the patch, which turned yellow with brown crusts after 24 hours. After 48 hours there were still some oedematous areas surrounded by a dry yellow crust. The oedema subsided after 72 hours; however, brownish-yellow crusts were still noted after 14 days.
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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