Registration Dossier

Administrative data

Description of key information

acute oral:

rat (male): LD50 = 4.57 g/kg bw (ca. 4570 mg/kg bw; Smyth, H.F. et al., 1949)

acute inhalation:

rat, IRT: 2/6 animals died at 4000 ppm (19613.27 mg/m³) (Smyth, H.F. et al., 1949)

- acute dermal:

rabbits (male): LD50 = 10.0 ml/kg bw (ca. 8276 mg/kg bw; Smyth, H.F. et al., 1949)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The single oral toxicity was determined by gastric intubation of groups of 5 non-fastened, male Carworth Wistar rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Carworth Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reared in the oqn colony
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: animals were not fasted
- Diet (e.g. ad libitum): Rockland rat diet
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
no data, the dosages were arranged in an logarithmic series differing by a factor of 5
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male
Dose descriptor:
LD50
Effect level:
4 570 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 570 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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
abstract
Principles of method if other than guideline:
Concentrated vapor inhalation was performed exposing groups of 6 male or female albino rats to a flowing stream of vapor-loaded air. The vapor-air mixture was generated by passing 2.5 l/min of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 ml of the test substance in a gaswashing bottle. Inhalations were continued for 8 hours in a logarithmic series. The observation period lasted 14 days.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: 2.5 l/min
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
4000 ppm (19613,27 mg/m³)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Exp. duration:
4 h
Remarks on result:
other: 2/6 animals died at 4000 ppm (19613,27 mg/m³)
Mortality:
2/6 animals died during 14 days.
Clinical signs:
other: no data
Body weight:
no data
Gross pathology:
no data

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4 male animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 value and its confidence interval was estimated by the method of Thompson (1947).
Sex:
male
Dose descriptor:
LD50
Effect level:
8 276 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value:10 ml/kg = 8276 mg/kg bw (calculatd by the density of 0.8276 g/l)
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 276 mg/kg bw

Additional information

In a reliable publication of Smyth, H.F. et al (1949) the acute oral toxicity of the test substance was determined by gastric intubation of groups of 5 non-fastened, male Carworth Wistar rats. The LD50 was determined as 4.57 g/kg bw (ca. 4570 mg/kg bw).

In an Inhalation Risk Test performed by Smyth, H.F. et al. (1949) concentrated vapor was inhaled by groups of 6 male or female rats. The test concentration was 4000 ppm (19613.27 mg/m³). Inhalations were continued for 4 hours. The observation period lasted 14 days. After the 4 hour-exposure two of six animals died. No information on clinical signs was given.

Acute dermal toxicity was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino rabbits (Smyth, H.F. et al, 1949). The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days. An LD50 value of 10.0 ml/kg bw (ca. 8276 mg/kg bw) was established. No information on clinical signs was given.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).