Registration Dossier

Diss Factsheets

Administrative data

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:
none were observed
Body weight:
body weight development was nomal
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

Referenceopen allclose all

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:
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 .

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:
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:
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 .

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