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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
16 Sept. 2003 to 03 feb 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method. Material is well characterised.

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
Guideline:
other: Method B4, Commission Directive 92/69/EEC
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Bristol-Myers Squibb Animal Test Method Number PGEHS-16-2 for Acute Dermal Irritation
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(6-chloro-2-methylpyrimidin-4-yl)amino]-N-(2-chloro-6-methylphenyl)-1,3-thiazole-5-carboxamide
EC Number:
695-686-7
Cas Number:
302964-08-5
Molecular formula:
C16 H13 C12 N5 O S
IUPAC Name:
2-[(6-chloro-2-methylpyrimidin-4-yl)amino]-N-(2-chloro-6-methylphenyl)-1,3-thiazole-5-carboxamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Elevage Scientifique des Dombes
F-01400 Chatillon sur Chalaronne I France
- Age at study initiation: 11 weeks (male); 11-12 weeks females
- weight at study initiation: 1949,1993 and 2031 grams
- Caging: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 43/03) provided by Provimi Kliba AG, CH-4303 Kaiseraugst
- Acclimation: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
- water: Community tap water from FOllinsdorf, ad libitum.

ENVIRONMENTAL CONDITIONS
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning.

These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC.

The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral zone of same animal
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4hrs
Observation period:
1hr, 24hr, 48hr and 72hr after dressing removed
Number of animals:
3 ( animlas of both sexes were used.
Details on study design:
No necropsy was performed on the animals sacrificed at termination of observation.
All rabbits were sacrificed by an intravenous injection of Vetanarcol into the ear vein at a dose of at least 1 mUkg body weight (equivalent to 162 mg sodium pentobarbitone/kg body weight) and discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. No staining produced by the test item of the treated skin was observed. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
BMS540268 is considered to be "not irritating" to rabbit skin.