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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:
1958

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

Constituent 1
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(hydroxyethy​l)​methyl, chlorides
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:
No data
Body weight:
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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