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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No details about the test substance
GLP compliance:
yes (incl. certificate)

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: Harald Schriever, D 2740 Bremervörde
- Housing: individual
- Diet (e.g. ad libitum): Certified diet (periodically analysed for contaminations)
- Water (e.g. ad libitum): tap water (periodically analysed for contaminations)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin area of the same animal served as control
Amount / concentration applied:
0.5 ml of the test substance applied to ca. 6 cm² test site
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
Examination time points: 0-60min, 24 h, 48 h, 72 h after patch removal and thereafter once daily up to day 15. Scoring system as described in OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: the end of observation period (day 15).: score 1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: At the end of observation period (day 15): score 1 for 2 out of 3 rabbits

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substacne is a skin irritant. But effects are not completely reversible within 15 days.

In conclusion, classification as irritating is indicated according to Regulation (EC) No 1272/2008: H315 - Causes skin irritation.
Executive summary:

The test was performed according to OECD guideline 404. Three New Zealand rabbits were used; 0.5 ml of the undiluted test substance were applied to the skin; semiocclusive, 4 h exposure; post exposure observation period 15 days. The average score (24-72h) for erythema and edema was 1.2 and 1.3 respectively. The effects for edema was not fully reversible after 15 d.