Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99,8%.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3 , female
Details on study design:
experimental animals served also as control animals: the contralateral skin area not treated with test substance served as control.

Results and discussion

In vivo

Results
Irritation parameter:
other: Draize Scores
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Remarks on result:
other: No irritation/ corrosion observed
Other effects:
no data

Any other information on results incl. tables

No irritation/ corrosion observed.

Applicant's summary and conclusion

Executive summary:

The irritant/ corrosive effects of the test substance TEP were tested on the skin of female rabbits in accordance with the OECD Guideline No. 404 for testing Chemicals.

The substance was not irritating to the skin (exposure period: 4 hrs).