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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.2.2001 - 23.2.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
10-methoxy-5H-dibenz[b,f]azepine
EC Number:
225-172-6
EC Name:
10-methoxy-5H-dibenz[b,f]azepine
Cas Number:
4698-11-7
Molecular formula:
C15H13NO
IUPAC Name:
10-methoxy-5H-dibenzo[b,f]azepine

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: Not required, the untreated skin sites of each animal served as control.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable

Any other information on results incl. tables

Irritation

No erythema or edema was detected in any animal after any reading time point.

Colouration

Yellow staining of the treated skin by the test substance was observed in all animals on day 1, which did not hamper the scoring of the skin reactions.

Toxicity / Mortality

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
EU: not classified