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: guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Kn 172
SAT 030768
Batch No.: Kn-Gi 8634/1

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, 72 hours
Number of animals:
3

Results and discussion

Any other information on results incl. tables

No irritation was observed at treated site following a 4 hour exposure  period.
These results indicate that the test item, KN 172, has no irritant effect  on the skin of the rabbit following a 4 hour dermal exposure period.
European Directives concerning the classification, packaging and labelling  of dangerous substances and preparations (671548-EEC and subsequent  revisions) would indicate the following: Classification : Not required

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Executive summary:

The acute dermal imtation of KN 172 was investigated in the rabbit.

A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a

period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours

after the end of the exposure period.

No imtation was observed at treated site following a 4 hour exposure period.

These results indicate that the test item, KN 172, has no irritant effect on the skin of the

rabbit following a 4 hour dermal exposure period.

European Directives conceming the classification, packaging and labelling of dangerous

substances and preparations (671548fEEC and subsequent revisions) would indicate the following:

Classification: Not required

Symbol: None indicated

R-phrase: None indicated