Registration Dossier
Registration Dossier
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EC number: 209-639-1 | CAS number: 589-18-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 - 29 August 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylbenzyl alcohol
- EC Number:
- 209-639-1
- EC Name:
- 4-methylbenzyl alcohol
- Cas Number:
- 589-18-4
- Molecular formula:
- C8H10O
- IUPAC Name:
- (4-methylphenyl)methanol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex
- Sex: female
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: antibiotic free rabbit diet (SQC standard rabbit pellets produces by Special Diets Services, Witham, Essex) ad libitum
- Water: drinking water via automatic nozzels ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 51 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g powder with 0.5 mL destilled water. 0.5 g of the test material was placed evenly over a 2.5 cm square of surgical lint. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days after removal of the patches
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: left flank, immediately caudal to the last rib
- % coverage: not specified
- Type of wrap if used: Elastoplast, elastic adhesive bandage 10 cm wide
REMOVAL OF TEST SUBSTANCE
- Washing: yes, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours and 7 days after removal of the patches
SCORING SYSTEM:
- Method of calculation: Irritation was assessed and allocated a numerical value based on erythema and eschar formation or oedema formation (Draize scoring system).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2 &4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.166
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Irritation of the skin (erythema score 0.5 of 4) was only apparent in animal 3 after 1 and 24 h, after 48 h no effect was recorded.
- Other effects:
- - Other adverse local effects: not specified
- Other adverse systemic effects: not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- No skin irritating effects of the test item were recorded after 48h.
- Executive summary:
The test was based on the descriptions for skin irritation, EEC Commission Directive of 25 April 1984 (84/449/EEC), page 106 to 108 of document L251. 0.5 mL aliquots were applied over an areea of 6 cm² on the dorsal skin, clipped free of fur, of four albino rabbits. The material was held in contact with the skin under a semi-occlusice dressing for a four hour period after which the patches were removed. Skin reaction to the materials was assessed after 1, 24, 48 and 72 h and 7 days. Irritation of the skin was only apparent after 1 and 24 h, after 48 h no effect was recorded.
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