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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other: 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:
other: 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).