Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: Three disregarded studies are available. No conclusion can be made based on these studies. According to the ECHA disseminated dossier the LD50 male/female was determined to be 5184 mg/kg bw in a acute oral toxicity equivalent to OECD guideline 401. The LD50 value male was determined to be >5184 mg/kg bw and the LD50 female was determined to be 4050 mg/kg bw. 
Acute inhalation toxicity: The acute inhalation toxicity of the test item was determined. The LD50 was determined to be between 20.6 and 10.8 mg/L.
Acute dermal toxicity: The acute dermal toxicity of the test item was determined. The LD50 value was determined to be 1720 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Documentation insufficient for assessment

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute inhalation toxicity, no further details
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Type of inhalation exposure:
not specified
Vehicle:
not specified
Duration of exposure:
6 h
Concentrations:
Nominal concentrations: 15800; 5700; 3000 and 1100 ppm (57; 20.6; 10.8; 4 mg/L)
No. of animals per sex per dose:
4
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LC100
Effect level:
5 700 ppm
Exp. duration:
6 h
Remarks on result:
other: 20.6 mg/L
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 3 000 - <= 5 700 ppm
Exp. duration:
6 h
Remarks on result:
other: between 20.6 and 10.8 mg/L
Mortality:
At top level all animals dead.
5700 ppm: All were dead within 24 hours
Clinical signs:
other: Motor incoordination
Body weight:
Loss of body weight
Gross pathology:
no data
Other findings:
no data

15800 ppm (57 mg/L) : At the top level, all animals exhibited motor incoordination within 90 min. and all were dead within 3 hours. 5700 ppm (20.6 mg/L): Those exposed to 5700 ppm were unconscious at the end of exposure and died within 24 hours. Deaths were believed to be due to respiratory failure. 3000 ppm (10.8 mg/L): The rats exposed to 3000 ppm were als unconscious at the end of the exposure, lost weight for a few days and then recovered and survived. 1100 ppm (4 mg/L): Those exposed to 1100 ppm exhibited slight motor inccordination at the end of the exposure, appeared normal 24 hours later, experienced no weight loss and survived.

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation toxicity of the test item was determined. The LD50 was determined to be between 3000 and 5700 ppm (equivalent to 10990.556 and 20882.057 mg/m^3)
Executive summary:

The acute inhalation toxicity of the test item was determined. The standard acute method was conducted with 4 rats. Nominal concentration of 15800, 5700, 3000 and 1100 ppm (57, 20.6, 10.8 and 4 mg/L) were used. The rats were exposed to the test item over a period of 6 h. As a result the LC100 was determined to be 5700 ppm and the LC50 was determined to be between 3000 and 5700 ppm (equivalent to 10990.556 and 20882.057 mg/m^3). Furthermore at the top level, all animals exhibited motor incoordination within 90 min. and all were dead within 3 hours. 5700 ppm (20.6 mg/L): Those exposed to 5700 ppm were unconscious at the end of exposure and died within 24 hours. Deaths were believed to be due to respiratory failure. 3000 ppm (10.8 mg/L): The rats exposed to 3000 ppm were als unconscious at the end of the exposure, lost weight for a few days and then recovered and survived. 1100 ppm (4 mg/L): Those exposed to 1100 ppm exhibited slight motor inccordination at the end of the exposure, appeared normal 24 hours later, experienced no weight loss and survived.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
10 990.556 mg/m³
Quality of whole database:
Only secondary literature available

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute dermal toxicity, no further details
GLP compliance:
not specified
Test type:
standard acute method
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 hours
Control animals:
not specified
Details on study design:
no data
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 720 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:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity of the test item was determined. The LD50 value was determined to be 1720 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test item was determined. The test item was applicated occlusively as standard acute method. The rabbits were exposed to the test material over a period of 24 hours. The LD50 value was determined to be 1720 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 720 mg/kg bw
Quality of whole database:
only secondary literature

Additional information

Acute oral toxicity

Munch, J.C. (1972)

The acute oral toxicity of the test item was determined. The publication is classified as disregarded study with insufficient documentation for assessment. A LD50 value (rabbits) of 2027 mg/kg bw was determined.

Schaffarzick, R.W., Brown, B.J. (1952)

The acute oral toxicity of the test item was determined. The publication was classified as disregarded study because of insufficient documentation for assessment. The LD50 with rats was determined to be 1000 mg/kg bw.

Rowe and McCollister (1982)

The acute oral toxicity of the test item was determined. The study is classified as disregarded study. The LD50 with rats was determined to be between 1000 and 2000 mg/kg bw.

Acute inhalation toxicity

The acute inhalation toxicity of the test item was determined. The standard acute method was conducted with 4 rats. Nominal concentration of 15800, 5700, 3000 and 1100 ppm (57, 20.6, 10.8 and 4 mg/L) were used. The rats were exposed to the test item over a period of 6 h. As a result the LC100 was determined to be 5700 ppm and the LC50 was determined to be between 3000 and 5700 ppm (equivalent to 10990.556 and 20882.057 mg/m^3). Furthermore at the top level, all animals exhibited motor incoordination within 90 min. and all were dead within 3 hours. 5700 ppm (20.6 mg/L): Those exposed to 5700 ppm were unconscious at the end of exposure and died within 24 hours. Deaths were believed to be due to respiratory failure. 3000 ppm (10.8 mg/L): The rats exposed to 3000 ppm were all unconscious at the end of the exposure, lost weight for a few days and then recovered and survived. 1100 ppm (4 mg/L): Those exposed to 1100 ppm exhibited slight motor inccordination at the end of the exposure, appeared normal 24 hours later, experienced no weight loss and survived.

Acute dermal toxicity

The acute dermal toxicity of the test item was determined. The test item was applied occlusively as standard acute method. The rabbits were exposed to the test material over a period of 24 hours. The LD50 value was determined to be 1720 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Documentation insufficient for assessment

Justification for selection of acute toxicity – inhalation endpoint
Only secondary literature available

Justification for selection of acute toxicity – dermal endpoint
only secondary literature

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation according to Annex VI of Regulation (EC) 1272/2008
According to the harmonised Annex VI classification the substance is considered to be classified for acute inhalation toxicity cat. 4, H332 and STOT Single Exp. 3, H335 under Regulation (EC) No 1272/2008,.

Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the substance is considered to be classified as acute dermal toxicity category 4., H312, acute inhalation toxicity cat. 4 H332 and STOT Single Exp. 3 H335 under Regulation (EC) No 1272/2008.