Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
The study report contains the limited information on the test conditions because the study has been performed in 1980. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 110 - 155 g
Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20 % w/w
Doses:
7.943, 10.00, 12.59 and 15.85 g/kg
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
12 040 mg/kg bw
Based on:
test mat.
95% CL:
> 10 980 - < 13 200
Mortality:
7.943 g/kg: 0/1010.00 g/kg: 1/1012.59 g/kg: 7/1015.85 g/kg: 9/10
Clinical signs:
diarrhea
Interpretation of results:
GHS criteria not met
Conclusions:
Not classified according to GHS criteria.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
The study report contains the limited information on the test conditions because the study has been performed in 1988. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 130 - 170 g
Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20 % w/w
Doses:
6.310, 7.943 and 10.00 g/kg
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical signs
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
8 420 mg/kg bw
Based on:
test mat.
95% CL:
> 7 745 - < 9 155
Mortality:
6.310 g/kg: 0/107.943 g/kg: 3/1010.00 g/kg: 9/10
Clinical signs:
6.310 g/kg: Without any clinical sights of intoxication.7.943 g/kg: Mild diarrhea, languidness. From the 2nd day without any clinical sights of intoxication.10.00 g/kg: Mild diarrhea, languidness. From the 2nd day without any clinical sights of intoxication.
Gross pathology:
Dead and killed animals: without macroscopic organ changes.
Interpretation of results:
GHS criteria not met
Conclusions:
Not classified according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study 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
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
The study report contains the limited information on the test conditions because the study has been performed in 1988. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 212 - 234 g
Vehicle:
water
Details on dermal exposure:
TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5.0 g/kg - For solids, paste formed: yes
Doses:
5.0 g/kg
No. of animals per sex per dose:
5 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical signs
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No dead animals.
Clinical signs:
Without any clinical sights of intoxication.
Gross pathology:
Without macroscopic organ changes.
Interpretation of results:
GHS criteria not met
Conclusions:
Not classified according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification