Castor oil, dehydrated

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 Feb. 15, 1988 to Mar. 03, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although the study was conducted according to OECD Guideline 401 and EC Regulation 84/449/EWG

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EG-guidelines 84/449/EWG

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld
- Weight at study initiation: male: 191.2 - 197.5 g and female: 170.8 - 185.6 g
- Fasting before study: Yes
- Housing: Collective caging, cage type: Macrolon type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 50 - 80%
- Photoperiod: Fluorescent light, 120 lux, 12 h/d from 7 a.m. to 7 p.m.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

4763 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Recorded at Day 0, 7 and Day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, organ weights, histopathology, other: CNS symptoms, coordination, tone, reflex, autonomic functions

Statistics:

None

Preliminary study:

Two female rats were employed in a preliminary range finding study. The dose of the single oral administration was 5 mL/kg bw.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 763 mg/kg bw

Remarks on result:

other: None

Mortality:

No mortalities were observed

Clinical signs:

other: No clinical signs were observed

Gross pathology:

No macroscopic findings in the cranial, thoracic and abdominal cavity

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of linseed oil in rats was > 4,763 mg/kg bw.

Executive summary:

The acute oral toxicity of linseed oil was investigated in rats in accordance with OECD Guideline 401 and EG 84/449/EWG.

A single dose of 4,763 mg/kg bw of linseed oil was administered to 5 male and 5 female rats. Clinical signs, body weights and mortalities were recorded during the 14 d observation period. Immediately after death or at the end of the observation period, a complete necropsy was performed.

No mortality or any other adverse effect was observed in any of the animals.

The oral LD50 of linseed oil in rats was > 4,763 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 763 mg/kg bw

Quality of whole database:

A number of studies available to address this endpoint. The study chosen was the study based on the read across substnace hence maximum reliability rating of 2 assigned according to ECHA guidance, although the study was conducted according to OECD Guideline 401 and EC Regulation 84/449/EWG

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not available

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature source (documentation insufficient for assessment)

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Single dose of fully hydrogenated coconut oil was applied dermally to guinea pigs and animals observed for 7 d.

GLP compliance:

not specified

Test type:

other: No data

Limit test:

yes

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data

Duration of exposure:

Single dermal application

Doses:

3,000 mg/kg bw

No. of animals per sex per dose:

12

Control animals:

not specified

Details on study design:

No data

Statistics:

No data

Preliminary study:

No data

Sex:

not specified

Dose descriptor:

LD0

Effect level:

3 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality during 7 d observation period

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

No data

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under test conditions, the LD0 of fully hydrogenated coconut oil in guinea pig was found to be 3,000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study, undiluted fully hydrogenated coconut oil was applied at a dose of 3,000 mg/kg bw to the skin of 12 guinea pigs.

No deaths occurred during the 7 d observation period.

Under test conditions, the LD0 of fully hydrogenated coconut oil was found to be 3,000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Additional information

Data is available for substances representative of the constituents of castor oil, dehydrated.

Oral

Castor oil was tested in rat according to OECD Guideline 401. The resulting LD50 value was higher than the highest administered dose, i.e. > 5 mL/kg bw (equivalent to approximately 4,952 mg/kg bw) (Chibanguza, 1988a). No clinical signs were observed in the study. Linseed oil (rich in C18:2) and palm oil, which contain glycerides of chain lengths ranging from C16-18, including C18-unsatd., also showed LC50 values > 4,763 and > 5,000 mg/kg bw, respectively, in oral toxicity studies in rat (Chibanguza, 1988b; CIR, 2000). Two studies on coconut oil (C8-18 and C18-unsatd.) yielded LD50 values > 5,000 mg/kg bw (Biotech Index, 1970a; IUCLID, 2000a).

Fatty acids, C16-18 and C18-unsatd. and fatty acids, C8-18 and C18-unsatd. yielded LC50 values above 5,000 mg/kg bw when tested in rat according toto EU Method B.1 (Potokar, 1984 a and b).

Adducts formed by glycerides similar to those tested above are not expected to have higher acute toxicity than the individual glycerides. Uptake may be slightly slower due to size.

Based on the above information, castor oil, dehydrated is estimated to be of low acute oral toxicity. The lowest above-mentioned LD50 value of > 4,763 mg/kg bw (linseed oil; Chibanguza, 1988b) is taken as representative for the substance.

Dermal

In an acute dermal toxicity study (limit test) in rat the acute dermal LD50 for a glyceride (mono- and di-) with fatty acid chain lengths of C16-18, including C18-hydroxy (CAS No. 91845-19-1) was found to be > 2,000 mg/kg bw (Potokar, 1985). Further, fully hydrogenated coconut oil, a glyceride with chain lengths of C8-18 and C18-unsatd., was tested for acute dermal toxicity in guinea-pigs and found to have an LD50 > 3,000 mg/kg bw (CIR, 1986).

The acute dermal toxicity of castor oil, dehydrated, is likely to be lower than the oral toxicity as uptake of the constituents (glycerides and adducts) will be lower (see Chapter 5.1.3).The substance is therefore considered to be of low acute dermal toxicity. The lowest above-mentioned LD50 value of > 2,000 mg/kg bw is taken as representative for the substance.In conditions where aerosol or droplets may be formed (e.g. spray applications), appropriate respiratory protection is recommended as a risk management measure.

Inhalation

In accordance with Annex VIII Column 2 of REACH, a study to investigate the acute toxicity study by inhalation does not need to be conducted as the substance is not volatile and has a low vapour pressure of 7.43 × 10-5 Pa at 25 °C.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with Annex VIII Column 2 of REACH, a study to investigate the acute toxicity study by inhalation does not need to be conducted as the substance is not volatile and has a low vapour pressure of 7.43 × 10-5 Pa at 25 °C.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Overall, the weight of evidence suggests that castor oil, dehydrated will have low acute toxicity. Based on the above information, the substance is not considered to require classification for acute toxicity according to Directive 67/548/EC or Regulation (EC) No 1272/2008.