Registration Dossier

Administrative data

Description of key information

- Repeated dose toxicity, oral: NOAEL = 1000 mg/kg bw for the rat, (according to EU Method B.7 ); study Braun (2009) Repeated dose toxicity: oral
- Repeated dose toxicity, dermal: no study available
- Repeated dose toxicity, inhalation: no reliable study available

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

- oral

The toxicity of FAT 40841/A after repeated oral application was tested in rats to according to EU Method B.7 (study Braun (2009) Repeated dose toxicity: oral). The test item was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. A control group was treated similarly with the vehicle, bidistilled water, only.

The groups comprised 5 animals per sex which were sacrificed after 28 days of treatment. Additional 5 rats per sex and group were used at 0 and 1000 mg/kg. These animals were treated for 28 days and then allowed a 14-day treatment-free recovery period after which they were sacrificed.

All animals survived until scheduled necropsy. Dark feces were observed with dose-related speed of onset and mean severity. Although this was a test item-related finding, it was considered to be common following oral administration of dyestuffs and of no toxicological relevance.

After four weeks of treatment, dark discoloration of several organs (tongue, stomach, jejunum,ileum, cecum, colon, rectum, kidneys, and mesenteric lymph nodes) was noted macroscopically at various dose levels and considered to be related to the test item.

After two weeks of recovery, persistent dark discoloration of the kidneys was noted in previously treated rats.

Microscopically, no findings of toxicological relevance were noted in animals necropsied after four weeks of treatment. After two weeks of recovery, blue pigment (engulfed in pulmonary phagocytes) were noted in three animals.

Based on the results of this study, a no-observed-effect-level (NOEL) for FAT 40841/A could

not be established, but the no-observed-adverse-effect-level (NOAEL) was considered to be

1000 mg/kg body weight/day.

A classification for specific target organ toxicity is not necessary

- dermal

no data available

- inhalation

no data available


Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification

- oral:

Based on the above stated results on toxicity after repeated oral exposure no classification is necessary forFAT 40841/A regarding specific target organ toxicity according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU

- dermal:

As no data on toxicity after repeated dermal exposure is available for FAT 40841/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU

- inhalation:

As no data on toxicity after repeated respiratory exposure is available for FAT 40841/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU