Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

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:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts has been used in this end point as a read-across substance for Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate . A comparison of the two substances and a read-across justification can be found in section 13 of this dataset

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

68610-44-6

Cas Number:

68610-44-6

IUPAC Name:

68610-44-6

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Substance supplied by Rhodia as Miranol JC-HA acute oral toxicity study with no adverse effect at a dose of 2000 mg/kg in female rats (based on 83% purity in water). Results are expressed as nominal dose as 83% material

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Single dose of 2000 mg/l as 83% pure material

No. of animals per sex per dose:

6 Females
Dosage volume 20 ml/kg

Control animals:

no

Details on study design:

Clinical observations for 14 days post-treatment, followed by gross necropsy.
No tissue samples were retained
Body weights checked on Day 1, 8 and 15

Statistics:

Not necessary

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were reported

Clinical signs:

other: Other than post-dose hypoactivity and piloerection in all animals in all animals typical of distress of dosing procedures, no adverse effects noted

Gross pathology:

No adverse effects

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No adverse effect level > 2000 mg/kg
The substance is considered to be non-hazardous according to classification criteria.

Executive summary:

Substance supplied by Rhodia as Miranol JC-HA acute oral toxicity study with no adverse effect at a dose of 2000 mg/kg in female rats (based on 83% purity in water). The data was derived by a good quality GLP limit test in 2004

 

The lower molecular weight would suggest that has the potential to be more biologically active than the coco-amine derivative and together with the weight of evidence from similar substances, is considered to be a valid substance for read-across for acute toxicity