Castor oil, oxidized

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:

20 Sept - 18 Okt 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: In complience with GLP, according to OECD guideline 420.

Justification for data waiving:

other:

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd.
- Age at study initiation: 8 to 12 weeks
- Fasting period before study: food removed overnight prior to dosingreturned three to four hours after dosing
- Housing: in groups up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet (Harlan Laboratories) ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: at least 5 days
- Other: females nulliparous and non-pregnant
- Other: bodyweight variation did not exceed appr 20% of the bodyweight of the initially dosed animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

Single dose of 2000 mg/kg bw

No. of animals per sex per dose:

Total of 5 animals (females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: morbidity/mortality: twice daily, early and late, during normal working days, once dayly at weekends. Clinical observations half an hour and 1,2, and 4 hours after dosing, then daily for 14 days. Individual bodyweights recorded on day 0 (prior to dosing), day 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

not relevant

Preliminary study:

Prior to main test, a sighting test was performed (1 female rat dosed 2000 mg/kg bw), in which no toxicity was observed.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No signs of systemic toxicity were noted.

Body weight:

All animals showed expected weight gains in bodyweight over the observation period.

Gross pathology:

No amnomalities were noted at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this study. The substance does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Executive summary:

An acute oral toxicity test in rats was performed according to the fixed-dose procedure (OECD 420). Following a sighting test at a dose level of 2000mg/kg bw, an additional four fasted female animals were administered a single oral dose of test item (Castor oil, oxidized), as a solution in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study and all animals were subjected to gross necropsy.

No mortality was noted and no signs of systemic toxicity. No abnormalities were noted at necropsy. The oral LD50 of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

One reliable experimental oral acute toxicity study with rats according to OECD 420 and under GLP conditions is available, resulting in sufficient quality to assess this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The acute toxicity study by the inhalation route is waived n accordance with column 2 of REACH Annex VIII, as significant exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

16 February 2010 to 02 March 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study has been performed according to OECD and/or EC guidelines and according to GLP principles. Due to the read-across purpose it was given a Klimisch 2 rating, in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Wistar strain, Crl:WI (Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old) were selected
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: no
- Housing: Individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). During the acclimatization period the animals were group housed in Macrolon cages (MIV type).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
- Health inspection: A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 - 22.0ºC
- Humidity (%): 40 - 56%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From: 16 February 2010 To: 02 March 2010

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
After 24 hours of application, dressings were removed and the skin cleaned of residual test substance using tap water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg/kg (2.105 mL/kg) body weight. Dose volume calculated as dose level (g/kg) / density (g/mL).

Duration of exposure:

24 hours

Doses:

2000 mg/kg (2.105 mL/kg) body weight.

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.

Statistics:

Not Applicable.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

General/maculate erythema, thickening, yellow staining, scales and/or scabs were noted in the treated skin area of all animals during the observation period.

General tremors, hunched posture, shallow respiration, piloerection, ptosis and/or chromodacryorrhoea was observed for all females between Days 1 and 3. Chromodacryorrhoea was also observed for two males on Day 1.

Body weight:

The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals .

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained with the substance Blown linseed oil are suitable for the regulatory purpose of REACH for the substance Blown castor oil: LD50 dermal (rat): >2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute toxicity studies are available for the oral and dermal route. Exposure via inhalation is unlikely taking into account the vapour pressure of the substance.

An acute oral toxicity test in rats was performed according to the fixed-dose procedure (OECD 420). Following a sighting test at a dose level of 2000mg/kg bw, an additional four fasted female animals were administered a single oral dose of test item (Castor oil, oxidized), as a solution in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study and all animals were subjected to gross necropsy.

No mortality was noted and no signs of systemic toxicity. No abnormalities were noted at necropsy. The oral LD50 of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw under the conditions of this study.

An acute dermal toxicity test in rats was performed according to OECD402, with read across substance Blown linseed oil. 5 Rats were exposed to 2000 mg/kg of the test substance for 24h under occlusion. Mortality, body weight, and clinical signsy were observed up till 14 days after exposure. Furthermore, necropsy of the survivors was performed at the end of the observation period.

No mortality was noted and no signs of systemic toxicity. No abnormalities were noted at necropsy. The results obtained with the substance Blown linseed oil are suitable for the regulatory purpose of REACH for the substance Blown castor oil, therefore an LD50 dermal (rat) >2000 mg/kg body weight is applicable.

Justification for selection of acute toxicity – oral endpoint
The selected study is the key and only study for this endpoint.

Justification for classification or non-classification

Based on the available information, Blown castor oil does not need to be classified as acute toxic via the oral and dermal route in accordance with the classification criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.