β-Alanine, N-coco alkyl derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Study performed in 1994 and precise chemical composition not clear. The material tested was a commercial grade of the substance.
As the substance appears to be of low hazard, this study is considered valid
Further animal testing cannot be justified

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

β-Alanine, N-coco alkyl derivs.

EC Number:

284-219-9

EC Name:

β-Alanine, N-coco alkyl derivs.

Cas Number:

84812-94-2

Molecular formula:

C14 H29 N1 O2

IUPAC Name:

β-Alanine, N-coco alkyl derivs.

Test material form:

solid

Specific details on test material used for the study:

Only trade name provided in the test report. Probably commercial grade mixture with glycol present.
Brown/yellow liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five males and five females

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Single dose of 2000 mg/kg

No. of animals per sex per dose:

Five

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Piloerection and increased salivation were observed in all rats within five minutes of dosing and during the remainder of Day 1. In addition, residual dose (associated with the increased salivation) was apparent on Day 1.
There were no other clinical signs

Body weight:

Slightly low body weight gains were recorded for one male and two females on Day 8; these rats achieved anticipated gains on Day 15.

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Although the nature of the test material was not reoprted, the material of the trade name used in the report is typically 70% actives.
Even taking into account the level of actives and the maximum dose of 2000 mg/kg of the commercial grade material with solvent present, it can be predicted that the disciminating dose for the pure active would be below limits for classification.