Rape oil, reaction products with diethanolamine

Acute Toxicity: dermal

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read across study conducted on the structural analogue amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) hence maximum reliability rating of 2 assigned according to ECHA guidance, although study is acceptable, well-documented and meets basic scientific principles.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl)

EC Number:

268-935-9

EC Name:

Amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Cas Number:

68155-07-7

IUPAC Name:

68155-07-7

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 or test system 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:

other: All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.

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 structurally similar amides, C8-18 (even-numbered) 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 structurally similar amides, C8-18 (even-numbered) 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 substance 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 was found to be >2,000 mg/kg bw in albino rabbits and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).