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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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.: 36429032.
Molecular formula: C14 H10 N4 O3 S3.
CAS No.: 104797-47-9
Appearance: Yellow powder.
Purity: 92.9 % (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: 8 April 2005 according to the Certificate of Analysis, but extended to October 2005 based on investigations by the sponsor.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland.
- Age at study initiation: Ca. 8 w (males), 12 weeks (females).
- Weight at study initiation: mean of 263 g for males; mean of 229 g for females.
- Housing: Single caging
- Diet: Altromin 1324 forte ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22.5
- Humidity (%): ca. 65
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
Hair of the dorsal trunk was clipped with an electrical hair clipper one day before the application of the test substance. The test site was located on thedorsal thoracal region. A dermal administration was performed once by spreading the test substance on an area of about 10 % of the estimated body surface. An area of 6.5 x 8 cm was labelled in a relaxed animal, corresponding to 52 cm2.
The individual doses were calculated using the body weights determined at the day of the administration. A cellulose patch with the calculated amount of the test substance and soaked with deionised water to given optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape. Patch and tape were covered semi-occlusively by a dressing.
The duration of exposure was 24 hours.
At the end of the exposure period the dressing, the tape and the patch were removed. Residual test substance was wiped off using wet cellulose tissue.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5 males + 5 females.
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 5 times on the first day, then at least once each day.
- Frequency of weighing: before administration, 7 and 14 d p.a.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
1/5 females was affected 1 d after the administration. The findings was chromodacryorrhoea.
Chromodacryorrhoea is attributed to the discomfort caused by the dressing and is not considered to be a toxic affect.
Observations of skin condition: A yellow staining of the skin was observed in all animals from 1 d until a maximum of 4 d p.a. This stain is attributed to a staining property of the test substance and not considered to be a toxic effect. No other alteration of the skin was found.
Body weight:
Males: Body weights and body weight gain were unremarkable during the entire study in all males.
Females: Body weight loss was noted in 2/5 females in the first week. This might be due to the discomfort, caused by the dressing and was not considered to be toxicologically significant.
Gross pathology:
Effects on organs: No relevant changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No relevant toxic effects of the test substance were noted at the dose of 2000 mg/kg body weight.
Executive summary:

The standard acute dermal toxicity method according to the EU- and OECD-guidelines was applied. The substance was administered in a limit dose of 2000 mg/kg body weight to 5 male and 5 female rats.

No mortality occurred. No relevant toxic effects of the test substance were noted by signs in life and post mortem. The dermal LD50 was determined to >2000 mg/kg body weight.