Methyl ricinoleate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Mar - 8 Apr 1999

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl ricinoleate

EC Number:

205-472-3

EC Name:

Methyl ricinoleate

Cas Number:

141-24-2

Molecular formula:

C19H36O3

IUPAC Name:

methyl ricinoleate

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

OFA-SD (IOPS Caw)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Iffa Crédo, 69210 L'Arbresle, France- Age at study initiation: approximately 6 weeks- Weight at study initiation: 182 ± 10 g (males); 141 ± 5 g (females)- Fasting period before study: yes- Housing: The animals were housed in polycarbonate cages (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimatization period and five rats of the same sex during the treatment period.Each cage contained dust-free sawdust (SICSA, 94142 Alfortville, France).- Diet: A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France), ad libitum- Water: filtered (FG Millipore membrane (0.22 micron)) drinking water, ad libitum- Acclimation period: at least 5 days before the beginning of the study ENVIRONMENTAL CONDITIONS - Temperature (°C): 21 ± 2 - Humidity (%): 30 - 70 - Air changes (per hr): approximately 12; filtered, non-recycled air - Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

As the test substance was anticipated to be non-toxic at 2000 mg/kg bw, a limit test was performed by administering 2000 mg/kg bw of the test substance to one group of ten animals (five males and five females).The test substance was administered undiluted, taking into consideration its specific gravity (0.91 g/mL).The administration was performed in a single dose by oral route using a metal gavage tube fitted to a 1 ml plastic syringe (0.01 mL graduations).The volume administered to each animal was adjusted according to body weight determined on the day of treatment.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test substance and thereafter once daily. The animals were weighed individually just before administration of the test substance on day 1 and thereafter on days 8 and 15. - Necropsy of survivors performed: yes, all animals were killed by carbon dioxide asphyxiation and a macroscopic examination was performed.After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin.Evaluation of the toxicity of the test substance following a single oral administration in rats should include the relationship, if any, between the animals' exposure to the test substance and the incidence and severity of all abnormalities including behavioural and clinical abnormalities, macroscopic lesions, body weight changes, mortality and any other toxic effects.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified