Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD guidelines for testing of chemicals No.404 and EU method B.4 No.L251.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99.2%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Females, approx. 14 weeks old and weighing 2416-2876g at the start of treatment, sourced from Broekman Institute, Someren, The Netherlands.

Conditions: Standard Laboratory Conditions. Air-conditioned with 7.5-15 air changes per hour and hourly monitored environment with temperature 20 ± 3°C, relative humidity 30-70 %, 12 hours artificial fluorescent light / 12 hours dark.

Accommodation: Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands).

Diet: Pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands) approx. 100 g per day.

Water: Free access to tap-water diluted with decalcified water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5mL
Duration of treatment / exposure:
4h
Observation period:
14days
Number of animals:
3
Details on study design:
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper , exposing an area of approximately 100 square centimeters (10 cm x 10 cm).

Prior to test article administration, the animals were physically examined and the skin found to be intact and normal.

On test day 1, 0.5 ml of the test article was applied to the intact skin of the shaved area, using a surgical gauze patch 2x3 cm mounted on Micropore tape (3M, St. Paul, U.S.A.). The dressing was wrapped around the abdomen and anchored with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).

Duration of exposure was 4 hours.

Four hours after the application, the dressing was removed and the remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tapwater.

The skin reactions were assessed at approximately 55 minutes, 24, 48 and 72 hours and at 7 and 14 days after the removal o f the dressings and test article. In order to facilitate the scoring, the skin area concerned of all animals was shaved again a t least 3 hours before the observation on days 2, 8 and 15.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1.7
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
1.7
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7d
Score:
1
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14d
Score:
0
Max. score:
0
Remarks on result:
other: new skin formation in 2/3 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
2
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
2
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7d
Score:
1.7
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14d
Score:
0
Max. score:
0
Remarks on result:
other: new skin formation in 2/3 animals
Irritant / corrosive response data:
The observed skin irritation consisted of very slight to well-defined erythema and slight oedema. The irritation was reversible within 14 days after exposure.

No corrosive effect was evident on the skin.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation index of 3.5 which is moderately irritant when applied to the intact rabbit skin. The observed skin irritation consisted of very slight to well defined erythema and slight oedema. The irritation was reversible within 14 days after exposure. No corrosion effect was evident on the skin.