Registration Dossier
Registration Dossier
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EC number: 205-182-7 | CAS number: 135-19-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.08.1986 - 15.08.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12.05.1985
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-naphthol
- EC Number:
- 205-182-7
- EC Name:
- 2-naphthol
- Cas Number:
- 135-19-3
- Molecular formula:
- C10H8O
- IUPAC Name:
- 2-naphthol
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- animal weight: 2,6 - 3,2 kg
animal age: approx. 3 - 5 months
animal keeping: single cages in fully air-conditioned rooms
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 500 mg beta-Naphthol per animal
- Duration of treatment / exposure:
- exposure time: 4 h
- Observation period:
- The assessments were made after 30 min, 60 min., 24 h, 48 h, and 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- Patch test was carried out at the dorsal area of the torso after shaving.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: after 30min. and 60 min.
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: after 30 min. and 60 min.
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- no resulting erythema, no resulting edema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- During the whole test period no irritations for beta-naphthol on New Zealand rabbits were observed. Therefore, 2-Naphthol is classified as not irritating to the skin.
- Executive summary:
In a study according to OECD Test No. 404 Acute dermal Irritation/corrosion the skin irritation potential of 2-naphthol was evaluated in New Zealand White rabbits. Application of 500 mg was made onto the intact and shaved skin. There was no skin reaction observed within 72 hours. Therefore, the test item is classified as not irritating to the skin.
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