Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: AFNOR NF T 03-021
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : metiloil A
- Physical state: yellow liquid
- Storage condition of test material: at room temperature
- Composition of test material, percentage of components: mixture of methylesters of satured and insatured C16 to 18 fatty acids, no data
- Lot/batch No.: 1169
- Acid number: 7 mgKOH/g

Test animals

Species:
rat
Strain:
other: Sprague-Dawley/ Crl: CD (SD) BR
Sex:
male/female
Details on test animals 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

Administration / exposure

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

Results and discussion

Effect levelsopen allclose all
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:
From 10 minutes to 3 hours after administration, hypokinesia were noticed in all animals. No clinical signs from 3 hours to day 14.
Body weight:
no effect observed in comparison to control animals
Gross pathology:
no macroscopic findings were recorded at necropsy
Other findings:
no data

Applicant's summary and conclusion

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.