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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2008/04/28 to 2008/05/288
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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan france SARL
- Age at study initiation: 12 weeks (male)
12-13 weeks (females)
- Weight at study initiation: 2452g (male), 2287 and 2295 (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 (°C): 17-23°C
- Humidity (%): 30-70% (above 70% during cleaning process)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.