(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

52950-18--2

IUPAC Name:

52950-18--2

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 or test system 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.