Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-660-1
EC Name:
-
Cas Number:
104797-47-9
Molecular formula:
C14H10N4O3S3 (Hill formula) C14H10N4O3S3 (CAS Formula)
IUPAC Name:
(Z)-[1-(2-amino-1,3-thiazol-4-yl)-2-(1,3-benzothiazol-2-ylsulfanyl)-2-oxoethylidene]amino acetate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: T15-AE
Chemical name: syn-2-(2-Aminothiazol-4-yl)-2-(methylcarbonyloximino) aceticacid-mercaptobenzthiazolylester.
Supplier: Sponsor.
Batch No.: PBi 5/184.
Molecular formula: C14 H10 N4 O3 S3.
Appearance: Yellow powder.
Purity: 96.8 % (HPLC)
Conditions of storage: In the deep freezer, in the dark; may be used under light.
Stability at conditions of storage: 12 months.
Stability at room temperature: Ca. 2 weeks.
Expiry date: October 2003
pH: 8.1 of a 1 % suspension in water.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Weight at study initiation: 2.0, 1.9 and 2.0 kg
- Housing: Individual metal wire caging
- Diet: Altromin 2023, ad libitum
- Water): tap water via automatic watering system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean 18.6 °C
- Humidity (%): average of 55 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
Amount applied: 0.5 g test substance moistened with 1 mL deionised water, applied to an area of 25 x 25 mm.
Duration of treatment / exposure:
4 hours.
Observation period:
Skin was observed at 1, 24, 48 and 72 hours after dressing removal.
Number of animals:
3 females.
Details on study design:
Skin examinations:
The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.

General examinations:
The animals were examined once daily for other than local changes of the skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All areas treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
General signs of toxicity: No signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All areas treated with the test substance and all control areas were normal before the application and at each observation time.
Executive summary:

A skin irritation test was performed according to OECD and EU test methods. Three female rabbits were exposed to the test substance for 4 hours.

All areas treated with the test substance and all control areas were normal before the application and at each observation time. The test substance is not a skin irritant.