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EC number: 203-310-6 | CAS number: 105-57-7
Endpoint summary
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
- 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.
Referenceopen allclose all
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
