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Description of key information

The acute oral toxicity of the test substance was assessed. The acute oral LD50 was 3.55 g/kg with 95 % confidence limits of 2.45 – 4.65 g/kg.

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:
supporting study
Study period:
The study was conducted in 1975.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract only.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was administered orally to rats at a range of concentrations and the rats were observed for fourteen days.
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Test type:
other: No data
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
The test substance was administered orally to rats at a range of concentrations and the rats were observed for fourteen days.
Doses:
1.31, 2.56, 5.0 and 9.75 g/kg.
No. of animals per sex per dose:
10 animals per dose, sex not specified.
Control animals:
no
Details on study design:
The test substance was administered orally to rats at a range of concentrations and the rats were observed for fourteen days.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 550 mg/kg bw
Based on:
test mat.
95% CL:
2 450 - 4 650
Mortality:
Mortality occurred at 2.56, 5.0 and 9.75 g/kg.
Clinical signs:
other: At 1.31 g / kg and 2.56 g / kg slight lethargy was observed. At 5.0 g/kg lethargy and piloerection were observed. At 9.75 g/kg coma was observed.

Summary of mortality

Dose

g/kg

Death / No. of animals

Observation day

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1.31

0 / 10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2.56

2 / 10

0

0

1

0

0

0

0

1

0

0

0

0

0

0

5.0

8 / 10

7

1

0

0

0

0

0

0

0

0

0

0

0

0

9.75

10 / 10

9

1

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was 3.55 g/kg with 95 % confidence limits of 2.45 – 4.65 g/kg.
Executive summary:

The acute oral toxicity of the test substance was assessed. The acute oral LD50 was 3.55 g/kg with 95 % confidence limits of 2.45 – 4.65 g/kg. Therefore no classification is required.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 550 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 adverse effect observed
Dose descriptor:
LD50
Value:
5 mg/kg bw

Additional information

The test substance was administered orally and dermally to rats at a range of concentrations and the rats were observed for fourteen days. 

Oral LD50: Mortality occurred at 2.56, 5.0 and 9.75 g/kg. At 1.31 g/kg and 2.56 g/kg slight lethargy was observed. At 5.0 g/kg lethargy and piloerection were observed and at 9.75 g/kg coma was observed.

Dermal LD50: No deaths were observed at 2.5 g/kg. At 5.0 g/kg 2 out of 6 rabbits died on day 2.

Therefore no classification is required for either acute oral or acute dermal endpoints.


Justification for selection of acute toxicity – oral endpoint
The study was conducted on the target substance in vivo in an appropriate test species.

Justification for selection of acute toxicity – dermal endpoint
The study was conducted on the target substance in vivo in an appropriate test species.

Justification for classification or non-classification

Acute toxicity is defined as the adverse effects occurring following a single administration of a substance, or multiple doses given within 24 hours by the oral or dermal routes, or an inhalation exposure of 4 hours.

Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. Acute toxicity values are expressed as approximate LD50 or LC50 (inhalation) values.

A test substance is classified according to one of these four toxicity categories when the acute LD50 value is ≤ 2000 mg/kg for exposure via the oral route.

The oral acute LD50 of the test substance was 3550 mg/kg and is therefore not classified for acute oral toxicity.

The dermal acute LD50 was >5 g/kg and is therefore not classified for acute dermal toxicity.