Registration Dossier
Registration Dossier
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EC number: 200-712-3 | CAS number: 69-72-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 AVRIL 2008 to 28 MAY 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, without any deviation from the guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- 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:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 2-hydroxybenzoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan france SARL
- Age at study initiation: 12 weeks (male) / 12-13 weeks (females)
- Weight at study initiation: 2452 g (male), 2287 and 2295 g (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: 4 or 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23°C
- Humidity: 30-70% (above 70% during cleaning process)
- Air changes (per hr): 10-15
- Photoperiod: 12 hours light and 12 hours dark
IN-LIFE DATES: From: 07/04/2008 To: 22/04/2008
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: electric clipped
- Vehicle:
- other: moistened with purified water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test substance applied, with 0.5 mL purified water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- skin reaction assessed at 1, 24, 48 and 72 hours, and 7, 10, 14 days after exposure (after the removal of the patch)
- Number of animals:
- a single animal first (to assess the irritancy of the substance) and then 2 remaining animals
- Details on study design:
- TEST SITE
- Area of exposure: left flank of the animal
- % coverage: ca. 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch held in contact with the skin with an adhesive hypoallergenic aerated semi occlusive dressing and restrainer bandage wrapped around the abdomen
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: just after 4 hours exposure
SCORING SYSTEM: according to the Directive 2004/73/EC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- no skin reaction at any of the observation times, for the 3 animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, salicylic acid is not irritating according to the Directive 2004/73/EC and to the GHS, second Revised Edition, 2007.
- Executive summary:
In a primary dermal irritation study, young adult New Zealand White rabbits (1 male and 2 females) were dermally exposed to 0.5 g of salicylic acid moistened with 0.5 mL purified water. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 14 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.
The test item did not elicit any skin reactions at the application site at any of the observation times, all scores = 0. The individual mean score for erythema/ eschar and oedema for each of the 3 animals was 0.
Based upon the directive 2004/73/EC and the GHS classification, acid salicylic is considered as not irritating to the rabbit skin.
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