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Administrative data

Description of key information

The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity when administered repeated for 28 days was considered to be 1000 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
High quality GLP compliant guideline study

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity: oral

Currently no study to assess repeated dose oral toxicity of Disperse Blue 056 is available. However, source substance Disperse Blue 054/077 was evaluated for the potential to cause adverse effects on repeated exposure in a combined repeated dose toxicity study with reproductive and developmental screening via oral route.

In this study, the Disperse Blue 054/077 was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Polyethylene glycol 400). No toxicologically significant adverse effects in terms of clinical signs, behavioural assessments, body weight change and food and water consumption were observed during the study. Similarly, gross necropsy examination and histopathological evaluation of selected tissues also did not reveal any adverse effects caused by the administration of the test item. Hence, it was concluded that the oral administration of FAT 92504/C TE to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any significant toxicological effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day for either sex.

Repeated dose toxicity: inhalation

Currently no study to assess repeated dose inhalation toxicity of Disperse Blue 056 is available.The test substance has low volatility as its melting point >300 °C, so the potential for the generation of inhalable forms is low. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further absence of adverse effects from repeated exposure of test animals via the oral route in a combined repeated dose toxicity study with reproductive and developmental screening with source substance Disperse Blue 054/077, suggests the substance to have low toxicity. Hence no significant toxicity is expected via the inhalation route and safety for human health can be estimated via route to route extrapolation. Further, production and spray drying is performed in closed processes without isolation of reaction products. Isolated product is present in dust free granules (non-dusty solid). Taking into consideration all the above arguments, no repeated dose inhalation toxicity study was performed.

Repeated dose toxicity: dermal

Currently no study to assess repeated dose dermal toxicity of Disperse Blue 056 is available.However, it hasvery low solubility in water (<1 mg/L), hence dermal uptake is likely to be low asthe substance isconsidered as not sufficiently soluble in water to partition from the stratum corneum into the epidermis.Further absence of adverse effects from repeated exposure of test animals via the oral route in a combined repeated dose toxicity study with reproductive and developmental screening with source substance Disperse Blue 054/077, suggests the substance to have low toxicity. Hence no significant toxicity is expectedviathe dermal route and safety for human health can be estimatedviaroute to route extrapolation. Similarly absence of systemic toxicity or mortality in skin irritation as well as sensitization studies with target substance, supports the conclusion that no adverse effects are expectedviadermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the test item only show up upon dermal exposure and not after systemic application, hence further experiments to assess dermal toxicity are not taken into account.

Justification for classification or non-classification

Based on the above discussion, FAT 92504 does not warrant classification according to CLP (Regulation EC No. 1272/2008) criteria.