Registration Dossier
Registration Dossier
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EC number: 273-535-2 | CAS number: 68988-63-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 eye irritation. 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.
• The covered molecular log Kow range is from -2.08 to 3.69 and the target chemical is within the range. A data matrix report is listed in an attached excel file.
The prediction is based on 9 values, 3 of them (33.3%) equal to predicted value
Prediction confidence is measured by the p-value: 0.00567.
Data source
Reference
- Reference Type:
- other: Predicted data
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- OECD Toolbox Read-Across (grouping approach)
- GLP compliance:
- not specified
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
Results and discussion
In vivo
Results
- Remarks on result:
- probability of mild irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on read-across data, EC No. 273-535-2's main (C12) component is a category 2 eye irritant.
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