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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.