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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
The study was performed to assess the acute toxicity following oral administration of (R)-2-Chlormandelsäure in Wistar rats.
The study procedure was based on the OECD, EU and US EPA OPPTS guidelines.
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid
EC Number:
EC Name:
(2R)-2-(2-chlorophenyl)-2-hydroxyethanoic acid
Cas Number:
Molecular formula:
Hill formula: C8H7ClO3 CAS formula: C8H7CLO3
(2R)-2-(2-chlorophenyl)-2-hydroxyacetic acid
Details on test material:
- Name of test material (as cited in study report): (R)-2-chloromandelic acid; Substance No.: 01/0490-1
- Physical state: Solid (crystalline) / white to slight yellowish
- Analytical purity: 99.7 area-%
- Impurities (identity and concentrations):
- Date of Production: February 07, 2002
- Lot/batch No.: T138-02-01
- Storage condition of test material: Room temperature
- Homogeneity: Homogeneous by visual inspection
- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor.

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14-18 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: Kliba-Labordiät, Provimi Kuba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: for at least 1 week

- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
other: test substance in 0.5% carboymethylcellulose solution in doubly distilled water
Details on oral exposure:
- Concentration in vehicle: 20 g/100 ml


The test substance preparation was produced for each administration group shortly before administration in 0.5% CMC-solution (cleaned sodium carboxymethylcellulose, Hoechst AG) in doubly distilled water by stirring with high speed homogenizer (Ultra-Turrax).

2000 mg/kg
No. of animals per sex per dose:
3 male and 3 female animals
Control animals:
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

Body weight determination:
Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study. Additionally, at day of death in animals that died starting with study day 1.

Signs and symptoms:
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals; these records are maintained with the raw data.

A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.

Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2. Necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
One female animal was found dead on study day 1. No mortality occurred in the male animals.
Clinical signs:
Male animal symptoms
Clinical observation revealed impaired general state, dyspnoea, smeared fur and were observed from hour 2 until including study day 2 after administration.
Female animal symptoms
Clinical observation revealed impaired and poor general state, dyspnoea, staggering, piloerection, smeared fur, red clammy snout and were observed from hour 0 until including study day 1 after administration.
Body weight:
The mean body weights of the male animals increased throughout the study period. The mean body weights of the female animals increased during the first post exposure observation week but decreased during the second week.
Gross pathology:
The following macroscopic pathologic abnormality was observed in the animal that was found dead (1 female): lesion on the mucosal membrane of the glandular stomach with necrotizing surface. No macroscopic pathologic abnormalities were noted in the animals (3 males and 2 females) examined at termination of the study.

Any other information on results incl. tables


Analysis of test substance:

The stability of the test substance in the vehicle for the preparations: maximum application period was confirmed indirectly by analysis of homogeneity analysis of the concentration. The correctness of the homogeneity of the test substance preparation for the first administration was confirmed by analysis.


Conduct of analyses:

The analyses were carried out at the Analytical Chemistry Laboratory of the Experimental Toxicology and Ecology of BASF AG.


Analysis of feed:

In view of the aim and duration of the study the contaminants occurring in commercial feed should not influence the results.


Analysis of drinking water:

In view of the aim and duration of the study there are no special requirements exceeding the specification of drinking water.



Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2,000 mg/kg body weight for male and female rats.

Applicant's summary and conclusion