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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

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) verse (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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were obtained from Charles River Breeding Laboratories, Inc. 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. Acclimation period of at least 5 days. Animals were fasted overnight prior to proceeding a single oral dose.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single oral dose by gavage

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Similar to OECD TG 401. Single oral dose 5 male/5 female rats with 15-day post-administration observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

test mat.

Mortality:

All animals survived the 15-day post observation period. No deaths occurred.

Clinical signs:

other: Effect Males Females Salivation 3/5 4/5 Diarrhea 1/5 2/5 Decreased activity 1/5

Gross pathology:

All animals were subject to gross necropsy. There were 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 oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.