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Toxicological information

Acute Toxicity: oral

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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: no guideline was followed, observation period was only 7 days, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no
Remarks:
GLP was not compulsatory at this time
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- appearance: liquid
- content: 50% in water

Test animals

Species:
rat
Strain:
not specified
Remarks:
Gassner
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Doses: 8000, 6400, 5000, 4000, 3200, 2500 cmm/kg.
Concentration: 30% (v/v) aqueous solution
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days.
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weights.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 300 other: mm3/kg
Remarks on result:
other: worst case assumption: equivalent to LD50 = 1815 mg/kg considering the substance density and the 50% content of the substance in the test material
Mortality:
See table 1.
All animals exposed to 5000 cmm/kg and above deceased within 15 minutes. Surviving animals showed accelerated breathing and hunched position 2 hours after application, but no adverse effects were observed at day 3 and thereafter.
Clinical signs:
Directly after application accelerated breathing, tremors, apathy, abdominal position and clonic convulsions were observed.
Body weight:
Mean body weights wre determined to be 241.2 g for males and 167.1 g for females.
Gross pathology:
venous congestion

Any other information on results incl. tables

Table 1: Mortalities

Dose
cmm/kg
Concentration Number of animals Number of deceased animals within
1 h 24 h 48 h 7 d
8000 30% 10 M 10/10 10/10 10/10 10/10
10 F 10/10 10/10 10/10 10/10
6400 30% 10 M 10/10 10/10 10/10 10/10
10 F 10/10 10/10 10/10 10/10
5000 30% 10 M 10/10 10/10 10/10 10/10
10 F 10/10 10/10 10/10 10/10
4000 30% 10 M 9/10 9/10 9/10 9/10
10 F 9/10 10/10 10/10 10/10
3200 30% 10 M 3/10 3/10 3/10 3/10
10 F 5/10 5/10 5/10 5/10
2500 30% 10 M 0/10 0/10 0/10 0/10
10 F 0/10 2/10 2/10 2/10

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
oral LD50 (rat) = 1815 mg/kg bw
Executive summary:

10 rats per sex and dose were exposed to single doses of 2500, 3200, 4000, 5000, 6400 and 8000 cmm/kg test substance/kg via gavage. Directly after application accelerated breathing, tremors, apathy, abdominal position and clonic convulsions were observed. Within a 7 -day observation period, 2/20, 8/20, 19/20, 20/20, 20/20 and 20/20 animals died in the dose groups of 2500, 3200, 4000, 5000, 6400 and 8000 cmm/kg. Necropsy revealed venous congestion in deceased animals. A LD50 of 3300 cmm/kg was determined. The test material was an aqueous solution of the test subtance, containing 50% test substance. It is unclear whether the LD50 refers to the test material or pure test substance. Considering the test substance density, the LD50 of 3300 cmm/kg was converted to 3630 mg/kg. Applying a worst case approach, the LD50 was corrected to 1815 mg/kg bw accounting for the water content in the test material.