Registration Dossier

Diss Factsheets

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:
1970
Reliability:
1 (reliable without restriction)
Qualifier:
no guideline available
Principles of method if other than guideline:
The test item has been administered to rats at dose of 400, 800, 1600, 2000, 2500 e 3200 mg/kg bw by gavage.
GLP compliance:
no
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
400, 800, 1600, 2000, 2500 e 3200 mg/kg bw
No. of animals per sex per dose:
400 mg/kg bw: 10 males and 10 females
800 mg/kg bw: 10 males and 10 females
1600 mg/kg bw: 20 males and 20 females
2000 mg/kg bw: 10 males and 10 females
2500 mg/kg bw: 10 males and 10 females
3200 mg/kg bw: 10 males and 10 females
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 800 mg/kg bw
Based on:
test mat.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DL50 in male/female rats: 1800 mg/ kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 800 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:
1987
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure:
nose/head only
Duration of exposure:
4 h
Concentrations:
Group 1: 1.09 mg/L
Group 2: 3.49 mg/l
Group 3: 4.76 mg/L
No. of animals per sex per dose:
5 males and 5 females
Sex:
male/female
Dose descriptor:
LC50
Effect level:
3.82 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 for male and female rats is 3.82 mg/L/4h
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
3 820 mg/m³

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
Study period:
1970
Reliability:
1 (reliable without restriction)
Qualifier:
no guideline available
Principles of method if other than guideline:
The test item has been administered to rats at dose of 1000, 2000 and 4000 mg/kg bw.
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Vehicle:
water
Duration of exposure:
24 hours
Doses:
1000, 2000 and 4000 mg/kg bw
No. of animals per sex per dose:
1000 mg/kg: 2 males and 1 female
2000 mg/kg: 2 females and 1 male
4000 mg/kg: 4 males and 2 females
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 000 mg/kg bw
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 for male/female rabbits is 3000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Additional information

The L(E)C50 values obtained in the experimental studies for substances with different CAS numbers are comparable by read-across.


Justification for selection of acute toxicity – oral endpoint
The two available experimental studies report similar results, which involve the same hazard classififcation.

Justification for selection of acute toxicity – inhalation endpoint
The selected study is the only study reporting an exact LC50 value.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the only available for the dermal route.

Justification for classification or non-classification

Basing on the L(E)C50 values and according to Regulation 1272/2008/EC, the substance is classified as follows:

Acute Tox. 4, H302

Acute Tox. 4, H332

Categories Display