Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report Date:
1958

Materials and methods

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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
67.2% active

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals 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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
< 2.5 other: g/kg
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

Conclusions:
The dermal LD50 was less than 2.5 g/kg
Executive summary:

The product tested was applied to the skin of rats for 24 hours at a dose of 2.5 g/kg. All animals dies within 48 to 56 hours. The dermal LD50 was less than 2.5 g/kg.