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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:
2004-03-09 to 2004-03-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented GLP study performed according the OECD guideline 404 and the EU test method B.4

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): T002251
- Physical state: brown powder
- Analytical purity: 96%
- Lot/batch No.: 00410155
- Expiration date of the lot/batch: 2004-05-05
- Storage condition of test material: at room temperature (range of 20 +/-3°C), light protected
- pH: before study initiation: A formulation of 1% in water was prepared. The pH was found to be 5.
- Stability of test item: stable under storage conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at treatment: 12-13 weeks (male), 13-14 weeks (females)
- Weight at day of treatment: 2.378 kg - 2.596 kg
- Fasting period before study: no data
- Housing: standard laboratory conditions, individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing
- Diet (e.g. ad libitum): ad libitum , pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): ad libitum , community tap water from Füllinsdorf
- Acclimation period: at least 5 days , under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music was played during the daytime light period

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, weighed as delivered by the Sponsor and then moistened with 0.1 mL purified water before application
Duration of treatment / exposure:
4 hours
Observation period:
The skin of each animal was examined approximately 1, 24, 48, 72 hours after removal of the dressing.
Viability/mortality and clinical signs were assessed daily.
Individual body weights were recorded at start of acclimatization, on the day of application and at termination of observation
Number of animals:
3 (1 male number 37, 2 females number 38, 39).
As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-hour exposure, the test was completed using the two remaining animals for an exposure period of four hours.
Details on study design:
TEST SITE
- Area of exposure: 16 cm² (4 cm x 4 cm patch)
- % coverage: no data
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the removal of the patch, the treated area was rinsed with lukewarm tap water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Comission directive 92/69/EEC, July 31, 1992, approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritant / corrosive response data:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed.
The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the substance T002251 is considered to be not irritating to rabbit skin and does not need to be classified.