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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
see below
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Weight at study initiation: 200-340 g
Housing: individually
Diet: ad libitum
Water: ad libitum

ENVIRONMENTAL CONDITIONS
Temperature (°C): 26-28
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Concentration in vehicle: 60 % (w/v)
Doses:
22-37 mL/kg
No. of animals per sex per dose:
5 m / 5 f
Control animals:
not specified
Details on study design:
Duration of observation period following administration: up to 10 days
Necropsy of survivors performed: no data
Other examinations performed: clinical signs
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
yes, but not further specified
Clinical signs:
other: predominant sign of toxicity was narcosis
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In male and female Wistar rats a LD50 value of > 15000 mg/kg bw was reported. The predominant sign of toxicity was narcosis.
Executive summary:

In male and female Wistar rats a LD50 value of > 15000 mg/kg bw was reported. The predominant sign of toxicity was narcosis.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Unpublished study report cited in a peer-reviewed publication
Qualifier:
no guideline followed
Principles of method if other than guideline:
dynamic inhalation apparatus
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight at study initiation: 160-200 g
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
clean air
Details on inhalation exposure:
Exposure apparatus: dynamic inhalation
Analytical verification of test atmosphere concentrations:
yes
Remarks:
not further specified
Duration of exposure:
7 h
Concentrations:
not further specified
No. of animals per sex per dose:
In total 20 m and 20 f in study
Control animals:
not specified
Details on study design:
not further specified
Statistics:
no data
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 268 mg/m³ air (analytical)
Exp. duration:
7 h
Remarks on result:
other: f: >1268 mg/m3; m: >1830 mg/m3
Mortality:
no
Clinical signs:
other: none
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In Wistar rats, the 7 h LC50 in females was >1268 mg/m3 and in males >1830 mg/m3. The treatment caused no signs of toxicity or irritant effects.
Executive summary:

In Wistar rats, the 7 h LC50 in females was >1268 mg/m3 and in males >1830 mg/m3. The treatment caused no signs of toxicity or irritant effects.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 268 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In male and female Wistar rats a LD50 value of > 15000 mg/kg bw was reported. The predominant sign of toxicity was narcosis.

In Wistar rats, the 7 h LC50 in females was >1268 mg/m3 and in males >1830 mg/m3. The treatment caused no signs of toxicity or irritant effects.

Justification for classification or non-classification

Due to the effect levels obtained in the acute toxicity studies, no classification according to EU and GHS criteria is required.