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.
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: The test material was administered to the test animals as a single dose of 2,000 mg/kg bw
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No information

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:
2,000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.

Statistics:
No information

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 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 applicable
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute dermal LD50 of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was found to be > 2,000 mg/kg bw in albino rabbits.

Executive summary:

A limit test was conducted to determine the acute dermal toxicity of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) in albino rabbits. Three male and three female rabbits were administered a single dose of the test material at a level of 2,000 mg/kg bw. 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-hour exposure period the sleeve was removed and the skin sites gently cleansed. All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior. All animals survived. All animals appeared normal through Day 14. Two females that had abraded skin lost weight over the 14 -d post-exposure period. All remaining rabbits gained weight through Day 14.

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