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

Key value for chemical safety assessment

Effects on fertility

Description of key information

- Oral: study available
- Dermal: no study available
- Inhalation: no study available

Effect on fertility: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

- Oral: study available

- Dermal: no study available

- Inhalation: no study available

Short description of key information:
- Oral: study available
- Dermal: no study available
- Inhalation: no study available

Effects on developmental toxicity

Description of key information

- Oral: NOAEL 1000 mg/kg for both maternal and fetal toxicity/teratogenicity (OECD TG 414); study "Rudragowda, BSL, 103760, 2011, RL1"
- Dermal: no study available
- Inhalation: no study available

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

- Oral:

One fully reliable study is available (Rudragowda, BSL, 103760, 2011, RL1) conducted according to OECD TG 414 and GLP (Wistar rats, treatment d 5 – d 19, doses: 100, 300, 1000 mg/kg bw/day, oral gavage, pairing males: females = 1:2).

No test item related adverse findings were reported including bodyweight data, pregnancy rate, prenatal data litter data. The number of gross external abnormalities and skeletal abnormalities compared favourably between treatment groups and controls. Internal observation of the fetal viscera by free hand microdissection technique revealed a range of visceral abnormalities in all groups including control. There was statistically significant increase in heart hyperemia (without the aneurysmal changes) in MD and HD groups. This finding was observed with very less severity and showed lack of dose dependency. The terminally sacrificed animals belonging to the control and LD group revealed no findings, but there were lesions like spleen enlarged, lung with red spots and discolored kidney observed in MD or HD groups. These finding were observed in few individual animals and were not considered treatment related.

In conclusion, the repeated dose administration of FAT 40850/B TE to pregnant female Wistar rats at dosages of 100, 300 and 1000 mg/kg bw/day from Gestation Day 5 to 19 revealed no major toxicological findings in females and fetuses.

Based on the data generated from this study, the NOAEL for both maternal toxicity and fetal toxicity of FAT 40850/B TE in Wistar rats was 1000 mg/kg bw/day. As this threshold value is identical with the highest allowable dose for this study type according to the OECD TG 414, a classification of FAT 40850/B TE for developmental toxicity/teratogenicity is not necessary.

 

- Dermal: no study available

 

- Inhalation: no study available

Toxicity to reproduction: other studies

Additional information

- Oral: study available

- Dermal: no study available

- Inhalation: no study available

Justification for classification or non-classification

- Effects on fertility:

As no data on fertility is available for FAT 40850/B 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.

 

- Effects on developmental toxicity/teratogenicity:

Based on the above stated assessment of the developmental toxicity/teratogenicity potential of FAT 40850/B TE (absence of substance related adverse effects at 1000 mg/kg bw) the substance is deemed not to be toxic to the developmental toxicity/teratogenic and accordingly 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.