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Administrative data

Description of key information

Acute oral toxicity: a study similar to OECDTG401: LD50 = 4700 mg/kg bw

Acute inhalation toxicity LC50 route to route extrapolation = 12200 mg/m3

Acute dermal toxicity: a study similar to OECDTG402: LD50 = 4700 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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study was performed predating current guidelines
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
3.2, 4.0, 5.0 and 6.3 g/kg bw
No. of animals per sex per dose:
10 animals (sex unspecified) per dose group
Control animals:
no
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 020 - <= 5 500
Mortality:
3/10, 6/10 and 9/10 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively
Distribution of mortality:
- 3200 mg/kg dose group: no mortality occurred
- 4000 mg/kg bw dose group: 1 animal died on day 1 and 2 animals died on day 3.
- 5000 mg/kg bw dose group: 1 animal died on day 1 and day 2, 3 animals died on day 5.
- 6300 mg/kg bw dose group: 6 animals died on day 1, 2 animals died on day 2 and 1 animal died on day 5.
Clinical signs:
Immediate stimulation followed by ataxia (uncoordinated movements)
Gross pathology:
Enteritis (inflammation of the gut) was seen.
Interpretation of results:
other: Not acute harmful
Remarks:
in accordance with CLP (1272/2008 and its updates)
Conclusions:
The acute oral toxicity test showed an LD50 of 4700 mg/kg bw
Executive summary:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 3.2, 4.0, 5.0 and 6.3 g/kg bw. 3/10, 6/10 and 9/10 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Directly after dosing stimulation and ataxia (uncoordinated movements) were seen. Enteritis (inflammation of the gut) was seen at gross pathology. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 4700 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study was performed predating current guidelines
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
Not specified
Doses:
3.2, 4.0, 5.0 and 6.3 g/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 200 - <= 5 260
Mortality:
1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively
Distribution of mortality:
- 3200 mg/kg bw: no mortality
- 4000 mg/kg bw dose group: 1 animal died on day 5
- 5000 mg/kg bw dose group: 3 animals died on day 2 and 2 animals died on day 4.
- 6300 mg/kg bw dose group: 6 animals died on day 1
Clinical signs:
Ataxia (uncoordinated movements) and dermal irritation was seen.
Gross pathology:
Hemorrhagic enteritis (inflammation of the gut) was seen.
Interpretation of results:
other: Not acute harmful
Remarks:
in accordance with CLP (1272/2008 and its updates)
Conclusions:
The acute dermal toxicity test showed an LD50 of 4700 mg/kg bw in rabbits.
Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 6 rabbits (sex unspecified) were administered 3.2, 4.0, 5.0 and 6.3 g/kg bw test substance on the skin. 1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Clinical signs was ataxia and hemorrhagic enteritis during gross pathology. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was 4700 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 3.2, 4.0, 5.0 and 6.3 g/kg bw. 3/10, 6/10 and 9/10 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Directly after dosing stimulation and ataxia (uncoordinated movements) were seen. Enteritis (inflammation of the gut) was seen at gross pathology. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 4700 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful.

Acute inhalation toxicity

The acute inhalation toxicity for the substance can be derived using data on the acute oral toxicity using the following methodology: CLP guidance (2017; 3.1.5.1.8. Example 8, page 264): using the extrapolation formula 1 mg/kg bw = 0.0052 mg/L/4h. The LD50 of the substance for acute oral toxicity is 4700 mg/kg bw. This value can be converted to 24.44 mg/L or 24.44 g/m3. Taking into account the inhalation absorption as 100% and oral absorption 50%, the acute inhalation toxicity would become 12.22 g/m3 = 12220 mg/m3. The maximum saturated vapour concentration for the substance is 287 mg/m3 (4.2 Pa (vapour pressure) x 168.28 (MW)) / (8.3 (R, gas constant) x 297 (°K)). This means that the substance cannot reach a concentration higher than 287 mg /m3. The extrapolated inhalation LC50 cannot be reached because it exceeds the saturated vapour pressure by more than a factor of 42.

Acute dermal toxicity

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 6 rabbits (sex unspecified) were administered 3.2, 4.0, 5.0 and 6.3 g/kg bw test substance on the skin. 1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Clinical signs was ataxia and hemorrhagic enteritis during gross pathology. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was 4700 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.

Justification for classification or non-classification

Based on the available information classification and labelling for acute oral, dermal and inhalation toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.