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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
Study period:
June 25, 1980 - August 4, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets the EC Standards (conducted equivalent to OECD 401). Deviations: lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
- Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material

Test animals

Species:
mouse
Strain:
CF-1
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 20 gram
No further details available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data available
Doses:
10, 15 and 20 mL/kg (aqueous solution)
No. of animals per sex per dose:
10 animals per dose (sex unknown)
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 5 days

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 - < 20 mL/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 37%
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 16 050 - < 21 400 mg/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 37%
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 939 - < 7 918 mg/kg bw
Based on:
other: expressed as solid content
Remarks on result:
other: Results expressed for the substance
Mortality:
- No mortalities occurred in the group administered 10 ml/kg.
- One and all ten animals died in the group of mice receiving 15 and 20 ml/kg bw, respectively
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

RESULTS 

Group

Dose

(mL/kg b.w.)

Mortality

Group mortality

(%)

1

10.0

0/10

0

2

15.0

1/10

10

3

20.0

10/10

100

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which can be converted to between 16,050 and 21,400 mg/kg (for the aqueous solution). This corresponds to a LD50 between 5,939 and 7,918 mg/kg for the substance.