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Administrative data

Description of key information

According to the available literature, the oral LD50 of the test substance is above 4000 mg/kg bw in rat (reference 7.2.1-1 to 7.2.1-3) and above 2360 mg/kg bw in rabbit (reference 7.2.1-4).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: Data collection
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline required
Principles of method if other than guideline:
- Principle of test: Data collection
GLP compliance:
not specified
Species:
rat
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Executive summary:

In the review article, an LD50 of 4600 mg/kg bw for the acute oral toxicity of the test item in rats is reported.

Endpoint:
acute toxicity: oral
Type of information:
other: Review article
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline required
Principles of method if other than guideline:
- Principle of test: Review article
GLP compliance:
not specified
Species:
rat
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Executive summary:

In the review article, an LD50 of 4600 mg/kg bw for the acute oral toxicity of the test item in rat is reported.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Determination of the acute oral toxicity in rabbits.
GLP compliance:
no
Remarks:
pre-GLP study
Species:
rabbit
Route of administration:
oral: gavage
Vehicle:
water
Doses:
15, 20, 25, 28.5, and 30 mmol/kg bw
No. of animals per sex per dose:
5 - 8
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 360 - < 3 540 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 20 - < 30 other: mmol/kg
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Executive summary:

In the review article, an LD50 range between 2360 and 3540 mg/kg bw for the acute oral toxicity of the test item in rabbits is reported.

Endpoint:
acute toxicity: oral
Type of information:
other: data collection
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline required
Principles of method if other than guideline:
- Principle of test: Data collection from several sources
GLP compliance:
not specified
Species:
rat
Route of administration:
oral: unspecified
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 570 mg/kg bw
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Executive summary:

In the review article, an LD50 of 4570 mg/kg bw for the acute oral toxicity of the test item in rat is reported.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch Code 4

Additional information

Oral Route

The available in vivo data on acute oral toxicity (publications) were used to assess the acute oral toxicity of the test item in a weight of evidence approach.

The assessment of the acute oral toxicity of the test item is based on avaiblable already published in vivo data in rat and rabbit. The LD50 values in rat are comparable (4570 mg/kg bw, reference 7.2.1-1; 4600 mg/kg bw, reference 7.2.1-2; 4600 mg/kg bw, reference 7.2.1-3). Rabbits seem to be more sensible for acute oral toxicity (LD50 > 2360, < 3540 mg/kg bw, reference 7.2.1-4). However, the general acute oral toxicity of the test substance has to be valuated as low. As consequence and in accordance to REACH Regulation (EG) No 1907/2006, Annex XI (1), the classification for acute oral toxicity is based on the available data. Additionally, in the interests of animal welfare and avoidance of unnecessary in vivo experiments, no in vivo study was performend recently. The values do not meet the GLP criteria for classification (UN GHS: No Category). Therefore, no further in vivo or in vitro studies were performed.

Inhalative Route

The toxicological properties of the test item were reviewed and summarised, presenting the following available data of the test item [1]. In a publication albino rats (n = 6) were exposed for 4 h to the test item [2]. After exposure the rats were observed for 14 days. A mortality of 2-4/6 was observed, depending on the dose group. Accordingly, a LCLo of 4000 ppm was determined. In another publication an LC50 of 1.94E+4 mg/m³ was determined [3].

[1] Opdyke D., Food Cosmet Toxicol. Aug;13(4):449-57, 1975

[2] Carpenter C. et al., J. ind. Hyg. Toxicol. 31, 343 1949

[3] Vrednie chemichescie veshestva, galogen I kislorod sodergashie organicheskie soedinenia, 501, 1994

Dermal Route

The toxicological properties of the test item were reviewed and summarised, presenting the following available data of the test item [1]. In a report to RIFM, an LD50 of above 5 g/kg bw was reported [4]. Furthermore, in rabbits an LD50 of 10 mL/kg bw was calculated [5].

[1] Opdyke D., Food Cosmet Toxicol. Aug;13(4):449-57, 1975

[4] Wohl A., Report to RIFM, 2 April 1974

[5] Smyth H. et al., J. Ind. Hyg. Toxicol. 31, 60, 1949

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are suitable for classification purposes under Regulation (EC) No 1272/2008.

As a result the test item is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.