reaction product of cocoalkyldiethanolamides and cocoalkylmonoglycerides and molybdenumtrioxide (1.75-2.2: 0.75-1.0:0.1-1.1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted similar to OECD Guideline under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Molyvan 855 (OD-855)

IUPAC Name:

Molyvan 855 (OD-855)

Constituent 2

Reference substance name:

-

EC Number:

430-380-7

EC Name:

-

Cas Number:

445409-27-8

Molecular formula:

Cannot be assigned due to being a complex reaction mixture

IUPAC Name:

Amides, coco, N, N-bis(hydroxyethyl), reaction products with coco monoglycerides and molybdenum oxide

Details on test material:

Although the common name is slightly different (OD-856 versus OD-855), the test substance is the same. The distinction between the two common names is dependent upon the production/process method used.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

10 young adult NZ white rabbits were obtained from Ace Animals, Inc for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. All animals were acclimated for a minimum of at lead 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg bw. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with masking tape. Animals were evaluated at the end of the 15-day post application observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 other: g/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: Observation Males Females Soft stools 3/5 0/5 Nasal discharge 1/5 0/5 Anorexia

Gross pathology:

No noteworthy findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.