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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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

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