Registration Dossier
Registration Dossier
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EC number: 201-487-4 | CAS number: 83-56-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only as secondary citation available: guideline study and GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
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:
- Naphthalene-1,5-diol
- EC Number:
- 201-487-4
- EC Name:
- Naphthalene-1,5-diol
- Cas Number:
- 83-56-7
- Molecular formula:
- C10H8O2
- IUPAC Name:
- naphthalene-1,5-diol
- Test material form:
- other: solid
- Details on test material:
- content: 99.9 %
batch no. 820211/01
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- males (no further data)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: adjacent areas of untreated skin served as control in each animal
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days after removing the test substance
- Number of animals:
- 3 males
- Details on study design:
- an aliquot of 0.5 g of the moistened test substance was applied to the clipped back skin of each animal. The patch was removed 4 hours after semi-occlusive contact and the skin was cleaned using water and ethanol. The skin reactions were assessed at approximately 1, 24,48 and 72 hours(all animals) and 7 days (2/3 animals) after removal of the dressings and test substance. Adjacent areas of untreated skin served as control in each animal.
Results and discussion
In vivo
- Irritant / corrosive response data:
- In 1 animal, slight (24 hours) to well-defined (48, 72 hours) erythema, slight (1, 24 hours) to very slight (48 hours) oedema and scaling (7 days) was observed after dressing removal
No erythema, oedema or scaling were recorded in 2/3 animals. - Other effects:
- Yellow staining of the treated skin area was noted 1-72 hours after removal of the test substance
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Executive summary:
1,5 -Dihydroxynaphthalene was tested for skin irritation according to OECD TG 404 using male New Zealand White rabbits. Under the conditions of the study, the test substance caused some irritation to rabbit skin, but - according to the authors - did not fulfil the EU criteria for classification.
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