Registration Dossier
Registration Dossier
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EC number: 242-332-0 | CAS number: 18448-65-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1958
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: non-interpretable for classification; Incomplete report; Inadequate details of study design and results; Composition uncertain
- Justification for type of information:
- Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
Materials and methods
Test guideline
- Version / remarks:
- No guideline available; inadequate details of study design and results
- Principles of method if other than guideline:
- No guideline available; inadequate details of study design and results
- GLP compliance:
- no
- Test type:
- other: Inadequate details of study design and results
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides
- EC Number:
- 274-846-6
- EC Name:
- Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides
- Cas Number:
- 70750-47-9
- IUPAC Name:
- Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides
Constituent 1
- Specific details on test material used for the study:
- 67.2% active
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Single dermal dose
- Duration of exposure:
- 24 hours
- Doses:
- 2.5 g/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- No data
- Statistics:
- No data
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- < 2 500 mg/kg bw
- Mortality:
- Two animals died within 36 hours and two succumbed within 48 to 56 hours after percutaneous application.
- Clinical signs:
- other: No data
- Gross pathology:
- No significant abnormalities were noted at autopsy other than local reactions. These local skin reactions were, however, quite severe. The skin became dry, wrinkled, and encrusted; necrosis had commenced prior to death.
Any other information on results incl. tables
The solvent (isopropanol) conceivably may have played an indirect role in promoting the absorption of the active ingredient through the skin, but it is unlikely that it directly affected the percutaneoas toxicity to any great extent. On the basis of active ingredient, the dose was 1. 68 g/kg. The dose of solvent (isopropanol) given was 0.82 g/kg. This latter value is considerably below the percutaneous LD50 for isopropanol (16. 4 ml/kg).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 was less than 2.5 g/kg.
- Executive summary:
The acute dermal toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study for which no guideline is available and details of the study design and results are noted to be inadequate.
This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
The study was assigned a reliability score of 3 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
Under the conditions of the study the dermal LD50 was determined to be < 2500 mg/kg bw.
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