Rape oil, oxidized

Endpoint summary

Description of key information

Acute toxicity (oral): >4985 mg/kg (OECD 401) and acute toxicity (dermal): >2000 mg/kg (OECD 402)

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:

February 15, 1988 - March 2, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Not GLP, but well described and in accordance with OECD 401.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

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: Charles River Wega, Sandhoferweg 7, 8714 Sulzfeld, Germany
- Age at study initiation: no data, but based on the animal weight at study start the animals were young adults.
- Weight at study initiation: male 182-188.8 g; females 160-164.3 g
- Fasting period before study: from 16 hours before treatment until 4 hours after treatment
- Housing:collective caging, Macrolon type III cages, with bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 50-80% rH
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light, fluorescent light, 120 lux

IN-LIFE DATES: From: February 15th 1988 To: March 2nd, 1988

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE; none (administered as received)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION (if unusual): administered as received

CLASS METHOD (if applicable): not relevant

Doses:

5 mL/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: mortality and symptoms about 20 min, 1 h, 2 h, 3 h, 6 h after treatment and once daily thereafter until day 14; weighing on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

not relevant

Preliminary study:

two female rats were administered 5 mL/kg bw; no mortality occurred.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 985 mg/kg bw

Based on:

test mat.

Remarks on result:

other: >5 mL/kg bw was equivalent to >4985 mg/kg bw

Mortality:

none

Clinical signs:

other: none were observed

Gross pathology:

no macroscopic findings in teh cranial, thoracic and abdominal cavity

Other findings:

no other findings

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral LD50 of blow rapeseed oil 60 P >5 mL/kg bw (>4985 mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 985 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 February 2010 to 02 March 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Reason / purpose for cross-reference:

reference to same study

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.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: 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 chromodacryo

Gross pathology:

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

For all details on the properties of the source material, the description of the analogue approach justification and the data matrix, see the attached document

Interpretation of results:

other:

Remarks:

CLP criteria not met.

Conclusions:

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

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

See attached justification

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: 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 chromodacryo

Gross pathology:

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

For all details on the properties of the source material, the description of the analogue approach justification and the data matrix, see the attached document

Interpretation of results:

other:

Remarks:

CLP criteria not met.

Conclusions:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute toxicity (dermal) is read-across from a supporting substance (structural analogue or surrogate).

Justification for classification or non-classification

The substance is not classified for acute toxicity as:

LD50 oral (rat): >4985 mg/kg

LD50 dermal (rat): >2000 mg/kg