Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-Mar-2012 - 28-Aug-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: white powder
- Analytical purity: 99.8%
- Lot/batch No.: 3334
- Storage condition of test material: at room temperature, protected from humidity and under nitrogen gas.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 290 ± 7 g for the males and 228 ± 6 g for the females
- Water and food: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG400
Details on dermal exposure:
TEST SITE
- Area of exposure: a dorsal area of the skin (approximately 5 cm x 6 cm for the females and 5 cm x 7 cm for the males)
- % coverage: approximately 10%
- Type of wrap if used: hydrophilic gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.64 mL/kg
- Constant volume or concentration used: no
Duration of exposure:
24 h
Doses:
A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of PEG 400) and then applied to the clipped area of the skin.
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 389 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
A reduced body weight gain or a slight body weight loss was seen in 2/5 females between day 8 and day 15. The overall body weight gain of the other animals was similar to that of CIT historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Because the test item in contact with purified water had a pH of 12. Criteria used for interpretation of results: expert judgment
Conclusions:
Under the experimental conditions, the dermal LD50 of CaTG is higher than 2000 mg/kg in rats.
Executive summary:

The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).

The application was performed with the test item in its original form at the dose-level of 2000 mg/kg. PEG 400 was used to moisten the gauze pad and ensure a good contact with the skin.

The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item.

All animals were subjected to necropsy.

No clinical signs and no deaths were observed during the study.

A reduced body weight gain or a slight body weight loss was seen in 2/5 females between day 8 and day 15. The overall body weight gain of the other animals was similar to that of CIT historical control animals.

Skin reactions were noted in almost all animals between day 3 and day 14 at the latest.

No apparent abnormalities were observed at necropsy in any animal.