Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
no guideline available
GLP compliance:
not specified
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200-300g
- Fasting period before study: yes
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
3 to 5 doses , maximum dose not specified, in oil
No. of animals per sex per dose:
5 each sex (female/male)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Sex:
male
Dose descriptor:
LD50
Effect level:
> 9.8 mL/kg bw
Based on:
test mat.
Remarks on result:
other: 8.7 g/gk bw /dose were given undiluted
Sex:
female
Dose descriptor:
LD50
Effect level:
10.8 mL/kg bw
Remarks on result:
other: 9.6 g/kg bw
Remarks:
doses were given undiluted
Mortality:
death at 15 min to 1 day
Clinical signs:
lethargy and prostragation
Gross pathology:
Necropsy (decents) revealed red lungs, gray stomachs (with clear fluid), white to red intestines (with clear fluid) and grey to red kidneys

lowest lethal dose= 8.0 mL/kg ( 7.1 g/kg bw)

The LD50 values were calculated according to the method of Thompson (1947)

female: LD50=10.8 mL/kg (8.9 to 13.1 mg/L) or 9.6 g/kg bw (7.9 to 11,7 g/kg bw)

male: LD 50 = 9.8 mgL/kg (7.2 -13.6 mL/kg) or 8.7 g/kg bw (6.4 to 12.1 g/kg bw)

 

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of the acute oral toxicity study in Sprague-dawley rats, the test substance has an LD50 value 8.7 to 9.6 g/kg bw.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Animals were exposed to the vapour for defined periods of time or until death occurred, in order to define LT50 values.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats (200-300 g), using 5 per sex.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: sealed chamber
- Exposure chamber volume: 120 litres
Sample vapour was employed in closed chamber "near saturation". No temperature is given in the report.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Remarks on duration:
Exposure lasted for 6 hours or until death occurred.
Concentrations:
Assuming a temperature of 25°C and a saturation of 90%, the vapor pressure of the substance is calculated as 55 hPa *0.9 = 49.5 hPa = 5% (v/v). With 102 g/Mol and 24.4 l/Mol a concentration of 210 mg/l is calculated.
No. of animals per sex per dose:
5 per sex (female/male)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
other: LT50
Effect level:
35 other: minutes
Based on:
test mat.
95% CL:
>= 26 - <= 47
Exp. duration:
6 h
Sex:
female
Dose descriptor:
other: LT50
Effect level:
32 other: minutes
Based on:
test mat.
95% CL:
>= 23 - <= 44
Exp. duration:
6 h
Sex:
not specified
Dose descriptor:
other: Only lethal exposure
Effect level:
45 other: minutes
Based on:
test mat.
Exp. duration:
6 h
Mortality:
Not specified.
Clinical signs:
Laboured breathing, lethargy, ataxia, lacrimation, discharge (nasal, oral) and loss of reflexes.
Gross pathology:
Red lungs, gas-filled stomachs and liquid-filled tracheas.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the results of the acute inhalation toxicity study, LT50s of 35 and 32 minutes were identified in male and female rats, respectively when exposed to near saturated vapor (estimated concentration of 210 mg/l). The available data indicate that a strong irritation of the respiratory tract occurred leading to the lethal effects found in the animals. The test substance will be classified as STOT SE 3 (H335) according to CLP.
Executive summary:

Five male & 5 female Sprague-Dawley rats/dose level were administered the test compound as a near saturated vapour, in a sealed 120 litre chamber containing near saturated vapour for 6 hours or until death occurred. Animals were observed for 14 days. Shorter exposures were also conducted (no additional information provided) in order to calculate the LT50s by using the Thompson method. LT50s of 35 and 32 minutes were identified in male and female rats, respectively. The available data indicate that a strong irritation of the respiratory tract occurred leading to the lethal effects found in the animals. The test substance will be classified as STOT SE 3 (H335) according to CLP.