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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20/1/1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch Number C2413/173/3

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72hours after removal of patch
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
GR101030X produced a Primary Dermal Irritation Index of 0.0 when applied for 4hrs, semi-occlusively to the skin of 3 New Zealand White rabbits. It is considered to be Non-irritating under the conditions of the test.
Executive summary:

A study was performed to assess the irritatncy potential of GR101030X to the skin of the New Zealand White rabbit. The method used followed that described in OECD No. 404 "Acute Dermal Irritation/Corrosion". A single 4 -hour, semi-occluded applicationto the intact skin of 3 rabbits produced no skin reactions. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.