Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

LD50(oral) > 2000 mg/kg (OECD 423 guideline)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423 guideline and GLP), 2000 mg/kg bw of the test item Eukesolar Rubine EB Liquid; dried (preparations in 0.5% solution of CMC) were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females). The following test substance-related clinical observations were recorded, clinical signs occurred within 3 days after administration at the latest:

2000 mg/kg (first test group):

- No mortality occurred

- Impaired general state in all animals

- Piloerection in all animals

2000 mg/kg (second test group):

- No clinical signs were noted in the animals and no mortality occurred

The body weight of the animals in both test groups increased within the normal range throughout the study period with two exceptions in the first test group. In these two animals the body weights were within the normal range during the first week, but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females). The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw

Justification for classification or non-classification

Based on the available acute oral toxicity study, no classification for acute oral toxicity is required.