Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 110 - 150 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
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
7 760 mg/kg bw
Based on:
test mat.
95% CL:
> 7 009 - < 8 592
Mortality:
6.310 g/kg: 1/10
7.943 g/kg: 6/10
10.00 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:
supporting study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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 1990. 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
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Name: Korostanová hněď DGR
- Source and lot/batch No.of test material: 190/89
- Composition:
Acid Brown 235 (70 - 80 % w/w)
Non-colour components (20 - 30 % w/w)
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 132 - 148 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; the highest dose: 3 animals
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:
ca. 8 000 mg/kg bw
Based on:
test mat.
Mortality:
6.310 g/kg: 0/10
7.943 g/kg: 5/10
10.00 g/kg: 3/3
Clinical signs:
30 min after application diarrhea
2 h after application malaise
24 h after application without clinical signs
Gross pathology:
Dead animals: significant colouring of tissues
Sacrificed animals: coloured kidneys
Interpretation of results:
GHS criteria not met
Conclusions:
Not classified according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 760 mg/kg bw

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:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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 1990. 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
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Name: Korostanová hněď DGR
- Source and lot/batch No.of test material: 190/89
- Composition:
Acid Brown 235 (70 - 80 % w/w)
Non-colour components (20 - 30 % w/w)
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 235 - 275 g
Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg
- For solids, paste formed: yes
Doses:
5 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 animals died.
Clinical signs:
Without any clinical signs of intoxication.
Gross pathology:
No macroscopically observable changes were detected in the organs.
Interpretation of results:
GHS criteria not met
Conclusions:
Not classified according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the test results and according to the CLP criteria for classification and labelling requirements for dangerous substances and preparations, the test substance, Acid Brown 235, did not fall into any of quoted categories of toxicity both oral and dermal, and has no obligatory labelling requirement in this respect.