Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
read across on structural analogue
Adequacy of study:
key study
Study period:
From 1984-05-17 To 1984-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 1a: The study is closely comparable to OECD guideline 401 and is GLP.
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
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
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:
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
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 inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Remarks:
read across on structural analogue
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not GLP and not enough details to consider it a full described study. It is scientifically valid to assess the endpoint
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Doses:
2000 mg/Kg
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was not considered to be an acute dermal toxic
Executive summary:

LD50 has been tested in a fixed dose test at 2000 mg/kg/bw on rabbit with fatty acids C6 -C12 methyl esters following EPA OPPTS 870.1200 with no sigh of toxicity

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

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.