Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Assessment of available information
Type of information:
other: Assessment of Toxicokinetic Behaviour
Adequacy of study:
key study
Study period:
January-May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other:
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline required
GLP compliance:
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.

Results and discussion

Applicant's summary and conclusion

Conclusions:
According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic (after single oral application).Direct Blue 78 did not penetrate into the organism through the skin after single application.The test compound is considered to be non-irritating to the eye of rabbit.The target organ of systemic toxicity after repeated oral administration in organism of males seems to be kidneys. The test substance is absorbed through the blood circulation and systemic effect occurs. But the extent of this effect is very small and it is manifested in animals of male sex only. Results recorded during the reproduction part of study with repeated oral administration showed that the test substance did not penetrate into the testes and through the placental barrier.