Benzeneacetic acid, .alpha.-hydroxy-, ammonium salt (1:1), (.alpha.R)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptabel for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

L-2-hydroxy-2-phenylacetic acid

EC Number:

210-276-6

EC Name:

L-2-hydroxy-2-phenylacetic acid

Cas Number:

611-71-2

IUPAC Name:

hydroxy(phenyl)acetic acid

Constituent 2

Reference substance name:

Mandelic acid

EC Number:

202-007-6

EC Name:

Mandelic acid

Cas Number:

90-64-2

IUPAC Name:

hydroxy(phenyl)acetic acid

Details on test material:

- Name of test material (as cited in study report): D-(-)-Mandelsaeure, technisch rein
no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Germany
- Weight at study initiation: group means males: 172-181 g; group means females: 179-181 g
- Fasting period before study: 16 hours
- Housing: five animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 29.4 %, 63.2 % or 50 %
- Amount of vehicle (if gavage): 5 or 10 ml/kg
- Justification for choice of vehicle: the test substance is insoluble in water


MAXIMUM DOSE VOLUME APPLIED: 5 or 10 ml/kg

Doses:

1470, 3160, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: observations were performed several times on the day of administration and at least once on each workday. A check for dead or moribund animals was performed twice on workdays and once on holidays. Weighing was performed on the day of dosing and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Probit analysis according to Finney.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Mortality:

no deaths occured at 1470 mg/kg bw, 0/5 male and 1/5 female animals died at 3160 mg/kg bw, 2/5 male and 3/5 female animals died at 5000 mg/kg bw

Clinical signs:

other: animals dosed with 1470 mg/kg bw were free of clinical signs animals dosed with 3160 mg/kg bw showed dyspnea, apathy, staggering, red-brown urine, piloerection and poor general state; these symptoms were observed until day 2 or 3. animals dosed with 3160

Gross pathology:

no abnormalities were detected in the animals that were sacrificed at the end of the study.
The following findings were made in animals that died during the study:
stomach: hemorrhagic gastritis in the mucosa region by corrosion.
forestomach and small intestines: mucosa reddened, adhesion of the stomach to the liver (1 x)