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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: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The acute dermal toxicity of the test item SR94653 was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (R)-2-chloromandelic acid
- Physical state: white powder
- Analytical purity: 99.7 %
- Lot/batch No.: 1500175 and CR-UY-002
- Stability under test conditions: guaranteed by the sponsor
- Storage condition of test material: at room temperature
- Other: The correspondence between both batch numbers (1500175 at receipt and CR-UY-002 on the analytical certificate) was confirmed by the Study Monitor in a statement dated 11 June 2001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: mean body weight ± standard deviation of 267 ± 14 g for the males and 228 ± 12 g for the females.
- Fasting period before study: none
- Housing: 1-7
- Diet: A04 C pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France) ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study

Each batch of food is analysed by die supplier for composition and contaminant levels. Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30-70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12

The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, die housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular intervals.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
A slight body weight loss was seen in 3/5 females between day 1 and day 8 and a reduced body weight gain was recorded in 3/5 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 exanimation of the main organs of the animals revealed no apparent abnormalities.

Any other information on results incl. tables

CONCLUSION

Under our experimental conditions, the dermal LD5o of the test item SR94653 is higher than 2000 mg/kg in rats.

Applicant's summary and conclusion