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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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

ORAL ACUTE TOXICTY

The substance was assessed for oral acute toxicity potential, using female rats. For the treatment, a 25 % emulsion in water (25 g/100 ml) was prepared and administered in the dosage of 5000 mg/kg body weight, once by gavage. No deaths occurred during the observation period; about 60 minutes after the treatment, all animals showed squat position and hair retention. Forty minutes later, passivity, miosis, dilated eyelids, and increased lacrimation were observed. 24 hours post application, all animals were free from clinical symptoms. Body weight and body weight gain were normal. The section of animals killed after the end of the experiment was macroscopically without any special features.

Although the test can be considered as sufficientely documented and meeting generally accepted scientific principles, it cannot be considered as acceptable for assessment because the content of Fluorescent Brightener 371 in the lot tested was very limited. Therefore, it has been here reported only for completeness sake.

To investigate the toxicity by oral route of FB371, an assessment, based on the toxicological properties of structural analogues and on the estimations of the QSAR toolbox 4.3, was therefore done confirming that no concerns arise from FB371.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

Based primarly on the information deriving from similar substances and from the estimations done by the QSAR toolbox 4.3, a LD50 value was estimated to be > 2000 mg/kg bw and therefore the substance was not classified for acute oral toxicity, according to the CLP Regulation (EC 1272/2008)