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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: LD50 (rat, m) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 2) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Item 8.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of esterification product of C16-C18 even numbered, saturated fatty acids and lactic acid, sodium salt (sodium stearoyl lactylate, SSL, CAS No. 25383-99-7, EC No. 246-929-7) was evaluated in accordance with the techniques specified in the Regulations for the Enforcement of the Federal Hazardous Substances Act (Jenni, 1975). The substance was administered by oral gavage to a group of 10 male albino rats at a dose level of 5000 mg/kg bw. The animals were observed for a periode of 14 days and body weights were measured at the start of the test and before terminal sacrifice. No mortality occurred after dosing with the test substance. 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 through to termination. No further clinical signs were observed. The average body weight gain was within the normal limits for rats of the age, sex and strain used. Necropsies revealed no gross pathological alterations. The acute oral LD50 value was found to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity of esterification product of C16-C18 even numbered, saturated fatty acids and lactic acid, sodium salt (sodium stearoyl lactylate, SSL, CAS No. 25383-99-7, EC No. 246-929-7) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.