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EC number: 201-186-8 | CAS number: 79-21-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 2000.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- source: Charles River Wiga GmbH, Sulzfeld, Germany
Age: about 20 days
Weight: 384 +/- 12.7 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: For intracutaneous application: dilution in aqua pro injection or dilution in aqua pro injection/Freund’s Complete Adjuvans For epicutaneous application: dilution in purified water.
- Concentration / amount:
- a) intracutaneous injection: 5 % (v/v)
b) 48 h occlusive bandage for topical induction: 10 % (v/v)
c) topical challenge: 2% (v/v)
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: For intracutaneous application: dilution in aqua pro injection or dilution in aqua pro injection/Freund’s Complete Adjuvans For epicutaneous application: dilution in purified water.
- Concentration / amount:
- a) intracutaneous injection: 5 % (v/v)
b) 48 h occlusive bandage for topical induction: 10 % (v/v)
c) topical challenge: 2% (v/v)
- No. of animals per dose:
- 5 in control group
10 in treatment group - Details on study design:
- In a skin sensitisation test according to Magnusson-Kligman, 10 guinea-pigs were treated with PAA solutions intracutaneously (day 0) and epicutaneously (day 7) for induction and epicutaneously (day 21) for challenge.
- Challenge controls:
- Day 21: epicutaneous application
- Positive control substance(s):
- yes
- Remarks:
- Positive response regularly checked with benzocain.
Results and discussion
- Positive control results:
- Results of the pre-test are summarised in table 6.1.5/01-1 (below).
After 48h no skin reactions were observed. Skin fold thickness was not different from control group.
After 72h no skin reactions were observed. Skin fold thickness was not different from control group.
Body weight was not influenced by the treatment.
Results of test (except LLNA)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not specified
- Total no. in group:
- 0
- Clinical observations:
- Not specified
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive response regularly checked with benzocain.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Not specified
- Total no. in group:
- 0
- Clinical observations:
- Not specified
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive response regularly checked with benzocain.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Negative control results not specified
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- Total no. in group:
- 5
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Negative control results not specified
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test vehicle
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 9 animals with grade 1, 1 animals with grade 2
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% test vehicle
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 3 animals with grade 1, 1 animals with grade 2
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Results of the Pre-Test | |||||||||||||
Application method | Concentration | Skin reaction after intracutaneous or epicutaneous application | |||||||||||
Animal no. 1 | Animal no. 2 | ||||||||||||
24h | 48h | 72h | 24h | 48h | 72h | ||||||||
left | right | left | right | left | right | left | right | left | right | left | right | ||
intracutaneous | 5 | E2 S | E2 S | E1 S | E1 S | E1 S | E1 S | E3 S | E3 S | E1 S | E1 S | E1 S | E1 S |
2 | E1 S | E2 S | S | E1 S | 0 | E1 S | E1 S | E2 S | E1 S | E1 S | E1 | E1 S | |
1 | E1 S | E1 S | E1 S | S | E1 | S | E1 S | E1 S | E1 S | S | E1 | 0 | |
0.5 | S | S | S | 0 | 0 | 0 | E1 | E1 | 0 | 0 | 0 | 0 | |
epicutaneous |
| Animal no. 3 | Animal no. 4 | ||||||||||
10 | E2 | E1 | 0 | E2 | E1 | 0 | |||||||
5 | E2 | E1 | 0 | E2 | 0 | 0 | |||||||
2 | E1 | 0 | 0 | E1 | 0 | 0 | |||||||
1 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
E = erythema grade (1 = discrete or patchy, 2 = moderate and confluent, 3 = intense) S = swelling 0 = no skin reaction | |||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions described in the study PAA has no skin sensitising effect.
- Executive summary:
In a skin sensitisation test according to Magnusson-Kligman, 10 guinea-pigs were treated with PAA solutions intracutaneously (day 0) and epicutaneously (day 7) for induction and epicutaneously (day 21) for challenge.
None of the animals showed any treatment related skin reaction (erythema, swelling, increased skin fold thickness). Body weights were within the normal range and did not differ from the control group.
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