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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 "Takawale, BSL, 103759, 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 (Takawale, BSL, 103759, 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). This prenatal developmental toxicity study of FAT 40849/C TE was conducted in pregnant female Wistar rats to detect possible adverse effects on pregnant females and embryofetal development when administered by oral gavage from Gestation Day 5 to 19.

No test item related adverse findings were reported including bodyweight data, pregnancy rate, prenatal data litter data except for a statistically significant increase in group mean number of live fetuses and female fetuses in MD group when compared with controls. Due to lack of dose dependency, this significant difference in parameters was considered to be incidental and not related to the test item. Decrease in pregnancy rate was observed in LD group (62.86. %), HD (80.00%), and MD (87.50) as compared to control (88.00%) but without clear dose dependence.

Statistically significant decrease in incidence of enlarged anterior and posterior fontanelle, incomplete ossification of Frontal (Bilateral), Parietal (B), Interparietal, Supraoccipital, Temporal (B), Zygomatic (B), 4th Sternebra and Xiphoid, Absent 4th Metacarpal (B), 14th rudimentary rib (B) and increase in incomplete ossification of 4th Sternebra was onserved in HD when compared with controls. There were also statistically significant decrease in incomplete ossification of Parietal (B), Interparietal, Supraoccipital and absent 4th metacarpal (B) in LD and 14th rudimentary rib (B) was observed in MD when compared with controls. Extra ossification of 4th sacral vertebral arch (B) was significantly increased in LD and MD when compared to controls. Internal observation of the fetal viscera by free hand microdissection technique and craniofacial examination by razor blade serial sectioning technique did not reveal clear treatment related adverse effects. There was increased number of incidences of blue/green discolouration of various visceral organs observed in treated groups and which could be attributed to the blue colur of the test item and as such of no toxicological significance.

In conclusion, the repeated dose administration of FAT 40489/C TE to pregnant female Wistar rats at dosages of 100, 300 and 1000 mg/kg body weight 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 40489/C TE in wistar rats was 1000 mg/kg body weight. 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 40489/C 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 40849/C 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 40849/C 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.