2-[(8-amino-7-{[4-substituted-2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonaphthalen-2-yl)diazenyl]-4-[(4-chloro-6-{[3-(substituted)phenyl](ethyl)amino}-heteromonocycl-2-yl)amino]arylsulfonic acid, potassium and sodium salts

Endpoint summary

Description of key information

- Oral: LD50: > 2000 mg/kg in female rats (OECD TG 423); study "Arcelin (2010) Acute toxicity: oral"
- Dermal: LD50: > 2000 mg/kg in female rats (OECD TG 402); study "Arcelin (2010) Acute toxicity: dermal"
- Inhalation: waiving due to non-exposure

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

- oral toxicity:

A LD50oral (gavage, RccHan:WIST (SPF) rats) of > 2000 mg/kg in female rats is reported for FAT 40849/A TE in the key study Arcelin (2010) Acute toxicity: oral" with a reliability score of 1 conducted according to OECD TG 423. No fatalities occured, body weight development was normal. Typical clinical signs were slight sedation and slightly ruffled fur (within the first 30 minutes after treatment, ruffled fur up to day 2), dark red eyes (3- and 5-hour readings) and black to dark blue faeces (day 2 up to day 3 or 4). The only other effect found was black brown discolouration of the kidneys at necropsy.

 

- dermal toxicity:

A LD50dermal (semiocclusive for 24 h, RccHan:WIST (SPF) rats) of > 2000 mg/kg in male and female rats is reported for FAT 40849/A TE in the key study Arcelin (2010) Acute toxicity: dermal" with a reliability score of 1 conducted according to OECD TG 402. No fatalities occured, body weight development was normal. Reported clinical signs were slight erythema and scaling in one animal, and blue staining of the application site up to d 8 – 14. In all animals, the moderate blue staining prevented the assessment of a possible erythema on test day 2 and 3. No other test item related effects were noted.

 

- inhalation toxicity:

No studies are available on the acute inhalation toxicity of FAT 40849/A TE. Based on column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the very low vapour pressure of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the inhalation route of exposure is considered to be unlikely, thus the study on acute inhalation toxicity is being waived.

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of FAT 40849/A TE (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified 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 toxicity:

Based on the above stated assessment of the acute dermal toxicity of FAT 40849/A TE (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified 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 toxicity:

Due to the very low vapour pressure of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the inhalation route of exposure is considered to be unlikely. Therefore no classification for acute inhalation toxicity is deemed necessary 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.