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:
2000/4/12-2000/6/22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD test guideline 404. GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute 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 UK Ltd
Number of Animals: Three
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.7-3.2 kg
Housing: Individually
Diet (e.g. ad libitum): Special Diet Service STANRAB SQC (pellets); ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°C): 18-21
Humidity (%): 53-65%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
Observation period:
24, 48, and 72h post application and once per day until Day 14
Number of animals:
Three females
Details on study design:
SCORING SYSTEM: Draize scale for dermal irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 1.7
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 Hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 13 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.1
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight edema followed exposure and was resolved by day 13.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Executive summary:

In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Petrepar 134 (50/50) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight oedema followed exposure and was resolved by day 13. The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).