Coupling reaction products of diazotized 2-amino-6-[(2-substitued ethyl)sulfonyl]naphthalene-1-substituted acid with 4-({4-chloro-6-[ethyl(3-{[2-(substituted oxy)ethyl]sulfonyl}phenyl)amino]-heteromonocycl-2-yl}amino)-5-hydroxynaphthalene-2,7-disubstituted acid and their sodium and potassium 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 4); 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 40850/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 occurred, body weight development was normal. No clinical signs were observed during the course of the study. Red feces were noted for all animals on test day 2. However, this colouration was most likely produced by the test item and was completely reversed by test day 3. No macroscopic findings were recorded 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 40850/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 occurred, body weight development was normal. No clinical signs were recorded throughout the complete observation period. In all animals, strong violet staining produced by the test item was noted on the treated skin area from test day 2 up to test day 6 or 9. However, this staining prevented the assessment of possible erythema. When assessable, no local dermal signs were observed in all animals. No macroscopic findings were observed at necropsy.

 

- inhalation toxicity:

No studies are available on the acute inhalation toxicity of FAT 40850/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 40850/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 40850/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 FAT 40850/A TE, 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.