Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 2-[3-formyl-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylate
EC Number:
700-743-7
Cas Number:
161798-03-4
Molecular formula:
C18H21NO4S
IUPAC Name:
ethyl 2-[3-formyl-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylate

Test animals

Species:
rabbit
Strain:
other: Japanese white strain
Details on test animals or test system and environmental conditions:
Following 1 week quarantine and acclimation, the animal were further maintained for 4 days until use.
Were placed in an environmentally conditioned room with temperature within 21-25ºC, a relative humidity within 45-65%, room air ventilation of approximately 15 times/hour, and lighting for 12 hours (from 7:00 to 19:00).

Test system

Vehicle:
other: A single closed-patch
Amount / concentration applied:
The test article was weighed and divided into 0.5g portions and each was wrapped in a piece of paper.
Duration of treatment / exposure:
A single closed-patch application for 4 hours
Observation period:
Macroscopic examination of the applied areas was carried out at 1, 24, 28 and 72 hours after the 4 hours application period.
Number of animals:
5 male rabbits of Japanesewhite strain (Kbs: JW, clean), 16-17 weeks old weighting 2.81 - 3.29 kg.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all three animals
Score:
ca. 0
Remarks on result:
other: at 1, 24, 48 and 72 hours
Irritation parameter:
edema score
Basis:
other: all three animals
Score:
ca. 0
Remarks on result:
other: after 1, 24, 48 and 72 hours
Irritation parameter:
primary dermal irritation index (PDII)
Score:
ca. 0
Remarks on result:
other: Was obtained by dividing the sum of individual irritation index by number of animal

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
These results demostrate that 4453 is evaluated to have no irritation effects on the skin of rabbits under the present test conditions.

Categories Display