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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A Primary Irritation Index (P.I.I.) of 1.2 was obtained at both intact skin and abraded skin on the white rabbit by the test substance. The test substance is thus, classified as slightly irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP and guideline mentioned. Basic data are given in the study report summary.
Principles of method if other than guideline:
Method according: Draize J. h., Woodard G.C. and Calvery H. O., J. Pharmacol. Expt. Therapeut 82: 377 (1944)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Japanese white rabbit (male)
Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data
Observation period:
No data
Number of animals:
6
Details on study design:
SCORING SYSTEM: : Primary Irritation Index (P.I.I) of the chemical evaluated based on skin changes appearing at 24 hours and 72 hours after application.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours and 72 hours after application
Score:
1.2
Reversibility:
fully reversible within: 72 hours to 192 hours after application
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Interpretation of results:
study cannot be used for classification
Conclusions:
A Primary Irritation Index (P.I.I.) of 1.2 was obtained at both intact skin and abraded skin on the white rabbit by the test substance. The test substance is thus, classified as slightly irritating.
Executive summary:

A Primary Irritation Index (P.I.I.) of 1.2 was obtained at both intact skin and abraded skin on the white rabbit by the test substance. The test substance is thus, classified as slightly irritating. Every skin changes on the 6 rabbits return to normal during the 72 hours to 192 hours after application.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A Primary Irritation Index (P.I.I.) of 1.2 was obtained at both intact skin and abraded skin on the white rabbit by the test substance. However, every skin changes on the 6 rabbits return to normal only 72 hours to 192 hours after application. The available information is thus regarded as inconclusive for classification


 


Justification for selection of skin irritation / corrosion endpoint:


Available study report summary.


 


Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

The results of the skin irritation are regarded as inconclusive for classification