Methyl ricinoleate

Endpoint summary

Description of key information

LD50 (rat, oral, OECD 401) > 2000 mg/kg bw

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:

25 Mar - 8 Apr 1999

Reliability:

1 (reliable without restriction)

Qualifier:

according 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:

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

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.

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.

Interpretation of results:

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

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The reliable GLP compliant OECD Guideline study was chosen.

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

Justification for Read-across

There are data available regarding acute oral toxicity for methyl ricinoleate (CAS 141-24-2). In addition, read-across data from the appropriate substances fatty acids, palm-oil, me esters (CAS 91051-34-2), methyl palmitate (CAS 112-39-0) and ethyl ricinoleate; ethyl 12-hydroxyoctadec-9-enoate (CAS 55066-53-0) are taking into account for oral toxicity as supporting information. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Acute oral toxicity

CAS 141-24-2

The acute oral toxicity of methyl ricinoleate (CAS 141-24-2) was tested in young Sprague-Dawley rats according to OECD guideline 401 and GLP (Arkema, 1999). The test article was given unchanged and once orally by mean of gavage in a limit dose of 2000 mg/kg body weight to 5 male and 5 female animals. 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. The surviving rats were sacrificed at the end of the 14-day observation period and a macroscopic postmortem examination was performed on all rats. No mortality and no clinical signs of toxicity were observed up to the end of the 14-day observation period. Necropsy revealed no substance-related findings and no effect on body weight was noted. Based on these results, the LD50 of methyl ricinoleate was > 2000 mg/kg bw for male and female rats.

Read across (CAS 112-39-0)

The acute oral toxicity of methyl palmitate (CAS 112-39-0) was tested in young Wistar rats according to OECD guideline 401 and GLP (BASF, 1992). The test article was dissolved in arachidis oil, DAB 9, and given once orally by mean of gavage in limit dose of 2000 mg/kg bw to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days (working days), the rats were observed for any signs of reaction. The surviving rats were sacrificed at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 of methyl palmitate was > 2000 mg/kg bw for male and female rats.

Read across (CAS 91051-34-2)

The acute oral toxicity of fatty acids, palm-oil, Me esters (CAS 91051-34-2) was tested in five male and 5 female Wistar rats in a limit test with a dose level of 5000 mg/kg bw (BASF, 1988). The test compound was administered by single gavage in arachidis oil as solvent. No mortality and no clinical signs of toxicity were observed up to the end of the 14-day observation period. Necropsy revealed no substance-related findings and no effect on body weight was noted. The LD50 was > 5000 mg/kg bw for male rats and for female rats.

Read across (CAS 55066-53-0)

The acute oral toxicity of ethyl ricinoleate ethyl 12-hydroxyoctadec-9-enoate (CAS 55066-53-0) was evaluated using 10 rats (RIFM, 2000). The acute oral LD50 exceeded 5000 mg/kg bw; one animal receiving this dose died. The following clinical signs were observed during the study: isolated instances of diarrhea, chromorhinorrhea, aptosis and chromodacryorrhea. At necropsy, gross observations were normal for eight animals. Necropsy of the remaining two animals revealed the following changes in either one or both animals: red and/or yellow areas in the intestines, red areas in the stomach, mottled liver, mottled spleen, mottled kidneys, dark lungs, red exudate in the anogenital area, and a large amount of blood in the bladder.

Conclusion

Based on the available data with the target substance methyl ricinoleate (CAS 141-24-4) and in consideration of the available supporting data with the source substances, methyl ricinoleate (CAS 141-24-4) did not reveal adverse effects in acute oral toxicity studies.

Justification for classification or non-classification

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