Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The report of the study does not include a lot of information regarding the methodology and results, therefore, it is unclear whether the study was well conductucted and it is not possible to assign a reliability code.

Data source

Reference
Reference Type:
other: unpublished report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: clear liquid

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2.56 g/kg bw, 3.20 g/kg bw, 4.0 g/kg bw, 5.0 g/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 200 mg/kg bw
Based on:
test mat.
Clinical signs:
The animals that died experienced sluggishness prior to death.

Any other information on results incl. tables

 

Observation Days

 

Dose (oral)

1

2

3

4

5

6

7-14

SUM

2.56 g/kg

0

0

0

0

0

0

0

0 / 10

3.20 g/kg

2

0

0

0

0

0

0

2 / 10

4.00 g/kg

6

1

0

0

0

0

0

7 / 10

5.0 g/kg

8

1

0

0

0

0

0

9 / 10

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item was found to be > 3.2 g/kg bw.
Executive summary:

In the current study it is unclear which method was used to determine the acute oral toxicity of the test item.

It is to be noted that the conclusion mentioned in the test report is an LD50 of 7.8 g/kg. This does not match the mortality scores per dose as tabulated in the test report. Based on the mortality scores, an LD50 > 3.2 g/kg bw is found. For precautionary reasons, the lower LD50 value is retained for the purpose of the registration dossier.

As this is > 2000 mg/kg bw, the substance should not be classified according to the CLP Regulation.