Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
One group of ten albino rabbits weighing between 2.5 and 3.5 kg each were employed in this study.
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.
All rabbits were weighed and the correct amunt of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities.

GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.
Duration of exposure:
24 h
Doses:
2 g/kg b.w.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
One group of ten albino rabbits weighing between 2.5 and 3.5 kg each were employed in this study.
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.
All rabbits were weighed and the correct amunt of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Not available
Body weight:
Not available
Gross pathology:
Not available
Other findings:
Not available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol was tested for acute dermal toxicity on rabbits. Test determined LD50 > 2 000 mg/kg b.w.
Executive summary:

Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol was tested for acute dermal toxicity on rabbits. Test determined LD50 > 2 000 mg/kg b.w.