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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:
during December 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with international guidelines.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: yellowish-white liquid
Details on test material:
Label: P5306
Storage: In a cool place at less than 30°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three young adult female New Zealand White rabbits obtained from Ranch Rabbits, Crawley, were used for the study.
At the start of the study the rabbits weighed between 3.82 and 4.65 kg and were at least 12 weeks old. They were acclimatised to the
laboratory environment for at least 3 days and were examined for signs of ill health or injury shortly before the study commenced.
All animals appeared healthy and no animals were rejected.
The animals were individually housed in grid floor cages in a single air conditioned room at a temperature between 19 and 25°C and a
relative humidity between 40 and 70%. The animals were exposed to a constant daily photoperiod of 12 hours artificial light and 12 hours
darkness. Temperature and humidity were recorded twice daily on weekdays and once daily at week-ends.
The animals were allowed free access to mains water and food (Standard Rabbit Diet, Special Diets Services Ltd., Stepfield,) throughout the study.
The animals were individually identified by means of a number on a metal ear tag. Each cage was identified by a coloured card giving details of
HLE project number, test article, dosage, sex, animal number, date of treatment, route of administration and the name of the
Home Office licensee responsible for the study.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL were applied to each treatment site.
Duration of treatment / exposure:
contact period 4 hours
Observation period:
One hour after removal, the evaluation was repeated 24, 48 and 72 hours after removal of the patches.
Number of animals:
3
Details on study design:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers.
A portion of test article (0.5 ml) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch.
The patch was occluded and secured using a strip of impermeable adhesive tape. A plastic collar was placed around the neck of each
animal to prevent premature removal of the wrappings and ingestion of the test article.
Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with water to remove
any test article still remaining.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No adverse skin reactions were noted during the study period. No corrosive effects were noted.
Other effects:
Not other effects observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No adverse skin reactions were noted during the study period. A primary irritation index of 0 was obtained. P5306 was regarded as
non-irritating to rabbit skin. No corrosive effects were noted.
Executive summary:

The skin irritation and corrosivity study in the rabbit was performed during December 1984 according to OECD Guideline 404 and GLP. No adverse skin reactions were noted during the study period and no corrosive effects were noted.

A primary irritation index of 0 was obtained. P5306 was regarded as non-irritating to rabbit skin.