Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 1.9-2.7 kg

No further information available.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the 24 h exposure period the sleeve was removed and the skin sites gently cleansed.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Details on study design:
All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities observed.
Clinical signs:
All animals appeared normal through Day 14.
Body weight:
Two females that had abraded skin lost weight (0.01 and 0.25 kg) over the 14 d post-exposure period. All remaining rabbits gained weight through Day 14.
Gross pathology:
Not evaluated.
Other findings:
Not evaluated.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute dermal LD50 in rabbits was found to be >2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976).