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: According to the OECD Guidline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No. GST 4-20079

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72 h
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 24h
Score:
> 0 - < 1
Reversibility:
fully reversible within: 24h

Any other information on results incl. tables

There were no generel toxic signs.

All aereas treated with the test substance were normal before application. The control aereas were normal at each observation time.

Examination one hour after patch removeal:

Erythema/eschar., very slight erythema (score 1,in ech animal) was observed in all animals.

Oedema: Only scores of "0", normal, were noted in all animals

The results at the reading time (24, 48 and 72 hours after ptaxh removal) are as follows.

Erytema/eschar : in animal No 2 and 3 very slight erytema (score 1, each) was seen 24 h after patsch removal, scores of "o", normal, were noted at the other reading times.

In animal No 1 very slight erythema was observed 24h and 48 after patsch removal, a soce of "o" was noted 72 h after the end of exposure.

Odema: In all animals very slight oedema (score 1, each) was found 24 h after patsch removal, scores of "0" normal, were noted at the reading time 48 and 72 hours after removal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
classification: not irritating
The Test substance DA 010894 Pyrazole DHE indicate no adverse skin reaction in this study
Executive summary:

The aim of the study wa to investigate possible reversible or irreversible irritancy and 7or corrosion by the tst substance following a single application to the intakt skin of rabbits.

Method and investigations were perfomed in conformance with the OECD Guideline 404.

Results:

There were no generel toxic signs.

All aereas treated with the test substance were normal before application. The control aereas were normal at each observation time.

Examination one hour after patch removeal:

Erythema/eschar., very slight erythema (score 1,in ech animal) was observed in all animals.

Oedema: Only scores of "0", normal, were noted in all animals

The results at the reading time (24, 48 and 72 hours after ptaxh removal) are as follows.

Erytema/eschar : in animal No 2 and 3 very slight erytema (score 1, each) was seen 24 h after patsch removal, scores of "o", normal, were noted at the other reading times.

In animal No 1 very slight erythema was observed 24h and 48 after patsch removal, a soce of "o" was noted 72 h after the end of exposure.

Odema: In all animals very slight oedema (score 1, each) was found 24 h after patsch removal, scores of "0" normal, were noted at the reading time 48 and 72 hours after removal.