Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 24 APR 2007 to 05 MAY 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404; EU method B4), in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

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: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.27 kg, 2,7 kg, 2,64 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet, ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 (air condition)
- Humidity (%): 32-64
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): a not further quantified amount of destilled water was used to moisten the test item
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (female)
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: as in OECD TG 404 described, reading at 1, 24, 48 and 72 h after removal of test item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h after removal of patches
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h after removal of patches
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritant / corrosive response data:
- No erythema or oedema were observed at any time point.
Other effects:
- Changes in body weight during the course of the study were not remarkable.
- No signs of systemic toxicity were observed.
- A red coloration was noted on the treated areas. Despite this coloration the macroscopical examinations of the cutaneous reaction were possible.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin when tested under the conditions of the OECD guideline 404.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.

The test item (0.5 g) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.