Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2000-09-14 to 2000-10-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 402 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Directive 88/320/CEE (Inspected on 1999-09-22)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Test material form:
liquid
Details on test material:
- Physical state: clear, colorless liquid
- Storage condition of test material: at room temperature, protected from light and under nitrogen gas

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS: Sprague-Dawley ICO: OFA-SD (lOPS Caw)
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: of 265 ± 11 g for the Males and 218 ± 8 g for the Females
- Fasting period before study: no
- Housing: housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
- Diet (e.g. ad libitum): free access to A04 C pelleted diet (DAR, 91360 Villemoisson-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Humidity (%):30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: until 2000-09-28

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% (5 cm x 6 cm for the females and 5 cm x 7 cm for the males) of the body surface of the animals
- Type of wrap if used: hydrophilic gauze pad held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done, no residual test substance was observed at removal of the dressing.
- Time after start of exposure: not applicable

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): taking into consideration the specific gravity of 1.0091 g/mL
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: frequently during the hours following administration of the test substance. Thereafter, at least once a day until day 15.
Weighing: prior to administration of the test substance on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight
- Necropsy of survivors performed: yes. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.
Statistics:
None

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
A reduced body weight gain was seen in 4/5 females between day 1 and day 8. 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.
Other findings:
None

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Dermal LD50Combined > 2000 mg/kg bw
Executive summary:

In a limit acute dermal toxicity study performed according to the OECD test guideline No. 402 and in compliance with GLP, groups of 8-week old Sprague-Dawley rats (5/sex)were exposed to undiluted ST 32 C 99 at dose of 2000 mg/kg bw. 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 ST 32 C 99. All animals were subjected to necropsy.

 

No clinical signs and no deaths were observed during the study. A reduced body weight gain was seen in 4/5 females between day 1 and day 8. The overall body weight gain of the other animals was similar to that of CIT historical control animals. No cutaneous reactions were observed. No apparent abnormalities were observed at necropsy in any animal.

Dermal LD50Combined > 2000 mg/kg bw

Under the test conditions, ST 32 C 99 is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.