Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1978

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Direct Blue 78- Physical state: solid, powder- Analytical purity: 95% (w/w)- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 10% (w/w)- Lot/batch No.: 7013/207- Expiration date of the lot/batch: unlisted- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: 110-145 g

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.