Linseed oil, oxidized

Endpoint summary

Description of key information

Acute toxicity (oral): the results of the 2 studies (OECD 401) are >4790 and >4986 mg/kg. The lowest is assigned as key value for the CSA.

Acute toxicity (dermal): the result of the study is >2000 mg/kg (OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 15, 1988 - March 3, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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: Firma Charles River Wiga, Sandhofer Weg 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: 185.2 - 189.1 g
female: 150 - 167.7 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): 20 ± 2 ºC
- Humidity (%): 50 - 80%
- 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 15, 1988 To: March 3, 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 (for pre-test and for main test)

No. of animals per sex per dose:

Pre-test: 2 females
Main test: 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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 790 mg/kg bw

Based on:

test mat.

Remarks on result:

other: >5 mL/kg bw was equivalent to >4790 mg/kg bw

Mortality:

No mortalities

Clinical signs:

other: No clinical-toxicological symptoms observed

Gross pathology:

No macroscopic findings in the cranial-, thoracic- and abdominal cavity

Other findings:

None

Interpretation of results:

not classified

Remarks:

based on Annex I of 1272/2008/EC (CLP)

Conclusions:

LD50 oral (rat): > 4790 mg/kg (>5 ml/kg)

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 15, 1988 - March 3, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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: Firma Charles River Wiga, Sandhofer Weg 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: 181.4 - 187.7 g
female: 158.4 - 165.3 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): 20 ± 2 ºC
- Humidity (%): 50 - 80%
- 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 15, 1988 To: March 3, 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 (for pre-test and for main test)

No. of animals per sex per dose:

Pre-test: 2 females
Main test: 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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 986 mg/kg bw

Based on:

test mat.

Remarks on result:

other: >5 mL/kg bw was equivalent to >4986 mg/kg bw

Mortality:

No mortalities

Clinical signs:

other: No clinical-toxicological symptoms observed

Gross pathology:

No macroscopic findings in the cranial-, thoracic- and abdominal cavity

Other findings:

None

Interpretation of results:

not classified

Remarks:

based on Annex I of 1272/2008/EC (CLP)

Conclusions:

LD50 oral (rat): > 4986 mg/kg (>5 ml/kg)

Endpoint conclusion

Dose descriptor:

LD50

Value:

4 790 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The substance does not need to be classified for acute toxicity as:

LD50 oral (rat): >4790 mg/kg

LD50 dermal (rat): >2000 mg/kg