Registration Dossier

Administrative data

Description of key information

oral: The LD50 was found to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-10-02 to 1990-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D 271
- Expiration date of the lot/batch: 16.07.1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 20 °C in fume cupboard
- Stability under test conditions: stable


Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 163 - 175 g (males); 177 - 185 g (females)
- Age at study initiation: males appr: 7 weeks, females appr. 8 weeks
- Fasting period before study: 16 hours before application
- Housing: in groups of 5 in macrolon cages
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water)
- Acclimation period: not necessary as breeding under identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test item was diluted in water (with a magnetic stirrer) to a concentration of 20 % (w/v).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopically examinations
Statistics:
not necessary
Preliminary study:
No details on preliminary study.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal died during the 14 days-observation period.
Clinical signs:
Reduced sponataneous activity, hunched posture, ruffled fur, tumbling gait, irregular breathing and respiratory sounds were noticed after administration.
Body weight:
One female animal exhibited a reduced body weight gain. The other animals exhibited a normal weight gain.
Gross pathology:
No macroscopically visible changes were found in the animals sacrificed at termination. The male animal that died during the observation period exhibited darkened liver, autolysis and its intestinal tract was filled with blood.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of the test item was determined to be > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five wistar rats of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. One male animal died during the observation period. The body weights were not affected except for one female rat exhibiting reduced body weight gain. No macroscopic changes were noticed at necropsy, the animal that had died during the observation period exhibited a darkened liver together with auolysis and a blood-filled intestinal tract. The LD50 of the test item was determined to be >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five wistar rats of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. One male animal died during the observation period. The body weights were not affected except for one female rat exhibiting reduced body weight gain. No macroscopic changes were noticed at necropsy, the animal that had died during the observation period exhibited a darkened liver together with auolysis and a blood-filled intestinal tract. The LD50 value of the test item was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.