Fatty acids, vegetable-oil, Me esters

Endpoint summary

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:

From 1984-05-17 To 1984-08-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a: The study is closely comparable to OECD guideline 401 and is GLP.

Qualifier:

according to guideline

Guideline:

other: AFNOR NF T 03-021

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Sprague-Dawley/ Crl: CD (SD) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 206 g (males) and 198 g (females)
- Fasting period before study: 17h to 17h20
- Housing: in groups of 5 in polycarbonate cage (42.0 x 27.0 x 15.0 cm)
- Diet (e.g. ad libitum): pelleted standard n° 1 Expanded SQC rat/mouse maintenance diet (Special Diets Services, Witham, Essex, U.K.), ad libitum
- Water (e.g. ad libitum): filtrated water with F.G. millipore membrane (0.2 µm), ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light


IN-LIFE DATES: no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: No vehicle
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality and clinical signs: daily after administration
body weight: days 0, 4, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination

Statistics:

No

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality at 5000 mg/kg bw.

Clinical signs:

other: From 10 minutes to 3 hours after administration, hypokinesia were noticed in all animals. No clinical signs from 3 hours to day 14.

Gross pathology:

no macroscopic findings were recorded at necropsy

Other findings:

no data

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Metiloil A was not considered to be an acute oral toxic.

Executive summary:

In an acute oral toxicity study (Kaysen A, 1984), groups of fasted, Sprague-Dawley Crl rats (5 males and 5 females) were given a single oral dose of metiloil A (batch No. 1169) at dose of 5 000 mg/kg bw and observed for 14 days. Oral LD0 (combined sex) is greater than 5000 mg/kg bw (limit test). No mortality was observed. From 10 minutes to 3 hours after administration, hypokinesia was noticed in all animals. Then, no clinical signs were observed. No effect on body weight was observed at the end of the observation period. Metiloil A is not classified based on the LD50 combined sex. This acute oral study is classified as acceptable. It does satisfy the guideline requirement (OECD 401) for an acute oral study in the rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

All studies on the substance and on the category members from primary and secondary literature reported no effect at the tested doses of 2000 or 5000 mg/Kg/bw for both oral and dermal routes. Inhalation route is not relevant based on exposure consideration and physical chemical properties of the substance.

Justification for classification or non-classification

Classification is only relevant for LD50 < 2000 mg/kg from any route of exposure and none of the tests have indicated such a result.

No classification for acute toxicity is warranted under 67/548/EEC or Regulation 1272/2008.