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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Regulations for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-stearoyllactate
EC Number:
246-929-7
EC Name:
Sodium 2-stearoyllactate
Cas Number:
25383-99-7
Molecular formula:
This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, SMILES, InChI and structural formula cannot be given.
IUPAC Name:
sodium 2-hydroxy-2-methyl-3-oxoicosanoate

Test animals

Species:
rat
Strain:
other: albino (Harlan Industries Inc.)
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries Inc., USA
- Age at study initiation: not specified in study report
- Weight at study initiation: 235 - 269 g
- Fasting period before study: approx. 18 h before dosing
- Housing: in groups in suspended wire mesh cages
- Diet: commercial pellets, ad libitum
- Water: ad libitum
- Acclimation period: not specified in study report

ENVIRONMENTAL CONDITIONS
- Not specified in study report

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v)

DOSAGE PREPARATION:
The test substance was suspended in the vehicle. No further details are given in the study report.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at frequent intervals during the day of dosage and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived until the end of the 14-day observation period.
Clinical signs:
other: 2/10 rats showed mucoid diarrhoea and stains on the day of dosage. On Day 7 3/10 animals exhibited diarrhoea stains for one to four days. Afterwards all animals exhibited normal appearance and behavior until termination.
Gross pathology:
Necropsies revealed no gross pathological alterations.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
In this acute oral toxicity study in rats a LD50 value of > 5000 mg/kg bw was determined.