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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics, other
Type of information:
other:
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary of available data
Executive summary:

BLUE GS 5664.80 has been tested for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes as well as for skin sensitisation.

In the test for acute oral and dermal toxicity, BLUE GS 5664.80 was applied to rats at a single dose level of 2000 mg/kg body weight. Neither mortality nor any substance-related systemic effects or changes on body weights and organs were seen.

In the skin sensitization test, none (0%) of the animals showed a sensitization reaction after epidermal application.

In a 28-day toxicity study, the substance was applied to rats at dose levels of 0, 50, 200 and 1000 mg/kg body weight daily by gavage. Neither mortality nor substance-related clinical symptoms were observed at any dose groups. No treatment-related effects were noted in body weights, food consumption, functional observational battery, locomotor activity and grip strength. No changes were observed in biochemistry, hematology and urinalysis parameters as well. There were neither test article-related effects on organ weights nor microscopic findings noted in any dose group. Macroscopic findings included bluish discoloration of the mucosa, of the stomach and/or small and large intestine in a number of animals of the mid and high dose groups.

The effects give rise to the assumption, that the test item will not or only partly be absorbed and/or is not toxic after oral application.

No other indications on the toxicokinetic behaviour of BLUE GS 5664.80 could be derived from the results of the available studies.

Description of key information

The substance is not expected to have bioaccumulative properties

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information