Registration Dossier

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
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
see below
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
predominant sign of toxicity was narcosis
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 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
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other: Unpublished study report cited in a peer-reviewed publication
Reference:
Composition 0
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
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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
1 268 mg/m³

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.