Registration Dossier
Registration Dossier
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EC number: 273-535-2 | CAS number: 68988-63-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 06 July 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- a. Category definition
A category of six analogues is defined for the purpose of data-gap filling of acute toxicity by the oral route (as LD50). The analogues are shown in the attached Category Report file.
b. Hypothesis for grouping chemicals
The working hypothesis is that the selected analogues can be grouped together for the prediction of acute toxicity by the oral route. The hypothesis is based on the profilers’ outcome, which supports the assumption that the analogues are structurally related and share similar reactivity. The grouping approach is described further in the attached Prediction Report.
c. Category description
• The category members are tertiary amines that are >50% structurally similar to the target chemical and are not categorized according to the US-EPA New Chemical Categories. For each
analogue, at least one LD50 for acute toxicity by the oral route is available. The LD50
values are expressed in mg/kg bw.
• The covered molecular weight range is from 287 to 370 Da and the target chemical is within the range. A data matrix report is listed in an attached excel file.
Data source
Reference
- Reference Type:
- other: Predicted data
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- Read-across prediction with QSAR Toolbox 4.4.1
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-C12-alkyl-1-(2carboxyethyl)-4,5-dihydro-3(hydroxyethyl)hydroxides, sodium salt
- Molecular formula:
- C20H39N2NaO4
- IUPAC Name:
- 2-C12-alkyl-1-(2carboxyethyl)-4,5-dihydro-3(hydroxyethyl)hydroxides, sodium salt
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 7 080 mg/kg bw
- Based on:
- act. ingr.
Applicant's summary and conclusion
- Conclusions:
- The predicted LD50 of the main (C12) constituent of Imidazolium compounds, 2-C7-18-alkyl-1-(2-
carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts EC / List no.: 273-535-2; CAS no.: 68988-63-6 is > 5,000 mg/kg bw.
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.
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