Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
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
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
other: LD50 limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amides, coco, N,N-bis(hydroxyethyl) (CAS 68603-42-9)

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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
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

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute dermal LD50 of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) 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 amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl)in male/female albino rabbit. 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.

 

2 g/kg bw of test material was applied (single application) to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material to ensure contact of the test 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 behavior for 14 d.

 

No mortality was observed in this study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.

 

Under the test conditions, the acute dermal LD50 of amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) was found to be > 2,000 mg/kg bw in albino rabbits.