Registration Dossier

Administrative data

Description of key information

Acute Toxicity- Oral point

Only one study is available. Klimish score 2.

LD50=9.822 g/kg (for male)

Acute Toxicity - Dermal point

Only one study is available. Klimish score 2.

LD50 > 5 g/kg/bw (for male)

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:
7.-11.1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and 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 1977. 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:
other: unknown
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 110-145 g
Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE- Concentration in vehicle: 20% w/w
Doses:
7,943 g/kg10,00 g/kg12,59 g/kg15,85 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- Frequency of observations and weighing: no data- Necropsy of survivors performed: yes- Other examinations performed: clinical signs
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
9.822 other: g/kg
Based on:
test mat.
95% CL:
> 8.462 - < 11.4
Mortality:
Number of deaths of each level: 7.943 g/kg: 2:10 10.00 g/kg: 7:10 12.59 g/kg: 6:10 15.85 g/kg: 10:10
Clinical signs:
clinical signs – diarrhea
Interpretation of results:
GHS criteria not met
Conclusions:
Based on determined value LD50 = 9,822 g/kg, the tested substance Direct Blue 78 has not been classified as acute toxic by the oral route.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
9 822 mg/kg bw

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:
02.-03.1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and 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 1991 . 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:
fixed dose procedure
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMAL- Number of animals: 5- Weight at study initiation: 264-294 g- Housing: 1 animal per cage
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE - Area of exposure: 4x6 cm, depilated skin - Type of wrap if used: mull, aluminium fall, plaster bandage REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24h TEST MATERIAL - Amount(s) applied: 5g/kg - For solids, paste formed: yes (substance+ 1,5 ml water)
Duration of exposure:
24h
Doses:
5.0 g/kg
No. of animals per sex per dose:
5 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: after 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical observation of animals was practised every day,
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Mortality:
no mortality during test
Clinical signs:
No clinilac signs after aplication
Body weight:
Normal weight gain
Gross pathology:
After 14 days all animals were sacrificed. No macroscipical findings were found.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not absorbed in a toxic quantity.
Executive summary:

The substance is not absorbed in a toxic quantity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification

Acute toxicity by oral route: Based on the available data the substance akardit is not classified.

Acute toxicity by dermal route. Based on available data the substance Akardit is not classified.