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Description of key information

Oral (similar to OECD 401), rat: LD50: > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³; limit test)

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
Study period:
13 Jan -2 Feb 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tuck & Sons Ltd, Battlesbridge, Essex, UK
- Weight at study initiation: 174 - 278 g (males and females)
- Fasting period before study: 16 - 20 h overnight
- Housing: 5 rats per cage in solid polypropylene cages, on softwood sawdust
- Diet: Rat Diet (Nottingham University, School of Agriculture, Nottingham, UK), ad libitum
- Water: mains tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
Range finding study: 10 and 20 mL/kg bw (corresponding to 8700 and 17400 mg/kg bw, respectively, based on a relative density of 0.87 g/cm³)
Main study: 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³)
No. of animals per sex per dose:
Range finding study: 1
Main study: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed to record mortality and clinical signs 1/2, 1 and 4 hour(s) after dosing and then once daily for fourteen days. The body weights of all animals were recorded on Day 0 and Day 14.
- Necropsy of survivors performed: yes
Preliminary study:
Based on the data of the dose range-finding study a dose level of 20 ml/kg bw was selected for the main test.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³)
Mortality:
No mortality occured during the observation period.
Clinical signs:
No overt signs of toxicity were observed up to the end of the observation period.
Body weight:
No effect on body weight was noted.
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 > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³) was found.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 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

Acute oral toxicity

The potential acute oral toxicity of Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7) was assessed in a study performed according to a protocol similar to OECD 401 (key study, 1982). 5 rats/sex were administered 20 mL/kg bw (corresponding 17400 mg/kg bw based on a relative density of 0.87 g/cm³) of the test substance by gavage. No mortality occurred. No clinical signs were observed during the 14-day observation period and no effect on body weight was noted. No unusual findings were reported during the macroscopic examination. Based on the results of the conducted study, the oral LD50 value is considered to be > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³).

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification