Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Refer to Section 13 for details of the read-across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

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:
other: LD50 limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
No details specified

Test animals

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

No further information available.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: The trunk of each animal was encased in a sleeve of plasticized material after application of test material




Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
Three animals with abraded skin and three animals with intact skin

Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 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 behavior for 14 d



Statistics:
Not reported

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed

Clinical signs:
All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.
Body weight:
Not reported
Gross pathology:
Not applicable
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the acute dermal LD50 was found to be >2,000 mg/kg bw in albino rabbits.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the read-across substance, amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl), in male and female albino rabbit. The procedure was 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'. A single dose of 2000 mg/kg bw was applied to the abraded and intact skin of rabbits. The trunk of each animal was then encased in a sleeve of plasticized material to ensure contact of the test material for a period of 24 h. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality was observed in this study. All animals appeared normal throughout the study. Under the conditions of the study, the acute dermal LD50 was found to be >2,000 mg/kg bw (Palanker, 1976).