Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Due to the availability of in vivo skin irritation data no new in vitro skin irritation tests were performed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.2.1983 to 26.02.1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
none
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: the test item was applied on a 2.5. cm square surgical lint patch to the intact skin of the rabbits
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
0ne, 24, 48, 72 and 168 hours
Number of animals:
3
Details on study design:
The study followed the UK Health and Safety
Commission's Approved Code of Practice, 'Methods
for Determination of Toxicity', Notification of
New Substances Regulations, 1982.

Accordingly, 0.5 g aliquots of
test material were moistened with distilled water
and applied on a 2.5 cm square surgical lint
patch to the intact skin of three albino
rabbits. These were held in place by a woven
material dressing and were thus semi-occlusive.
After 4 or 7 hours (equivalent to a half or one
day working period), the patches were removed and
irritancy assessed after one, 24, 48, 72 and 168
hours according to the Draize system of
classification.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Draize classification
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Skin irritancy after 4 hours exposition: none, according to Draize classification.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Skin irritancy after 4 hours exposition: none, according to Draize classification.
Executive summary:

The study followed the UK Health and Safety Commission's Approved Code of Practice, 'Methods for Determination of Toxicity', Notification of New Substances Regulations, 1982.

Accordingly, 0.5 g aliquots of test material were moistened with distilled water and applied on a 2.5 cm square surgical lint patch to the intact skin of three albino rabbits. These were held in place by a woven material dressing and were thus semi-occlusive. After 4 or 7 hours (equivalent to a half or one day working period), the patches were removed and irritancy assessed after one, 24, 48, 72 and 168 hours according to the Draize system of classification.

Skin irritancy after 4 hours exposition: none, according to Draize classification.