Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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

Constituent 1
Chemical structure
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
Molecular formula:
C8H8O3
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:
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 mg/kg bw showed dyspnea, apathy, staggering, tremors, red-brown urine, piloerection and poor general state; these symptoms were observed until 5 hours after dosing (tremors) or even until day 1, 2 or 3.
Body weight:
1470 mg/kg bw: male animals: day 0: 180 g, day 7: 241 g, day 13: 274 g; female animals: day 0: 179 g, day 7: 212 g, day 13: 222 g
3160 mg/kg bw: male animals: day 0: 172 g, day 7: 228 g, day 13: 265 g; female animals: day 0: 188 g, day 7: 206 g, day 13: 220 g
5000 mg/kg bw: male animals: day 0: 181 g, day 7: 228 g, day 13: 268 g; female animals: day 0: 181 g, day 7: 194 g, day 13: 212 g
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)

Applicant's summary and conclusion