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Effects on fertility

Description of key information
- other studies: no data available
Additional information

- fertility:

No study available.

The conduction of a Screening for reproductive/developmental toxicity study (OECD 421 or 422) was waived based on the availability of a Developmental toxicity / teratogenicity study (OECD TG 414) according to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, Annex VIII, Section 8.7.1.

In the repeated dose study (28 d, gavage, rats), no effects were seen in reproductive organs (see Braun (2009) Repeated dose toxicity: oral, section 7.5.1)

Due to the absence of a study covering the endpoint fertility a clear statement on the classification of FAT 40841/A TE for this endpoint is not possible. Nevertheless the negative results from the repeated dose study concerning effects on reproductive organs suggest that FAT 40841/A TE has a low potential for adverse effects on fertility. Accordingly to date a classification for this endpoint is not triggered.


Short description of key information:
- fertility: no study available, the conduction of a Screening for reproductive/developmental toxicity study (OECD 421 or 422) was waived based on the availability of a Developmental toxicity / teratogenicity study (OECD TG 414) according to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, Annex VIII, Section 8.7.1.

Effects on developmental toxicity

Description of key information
- developmental toxicity/teratogenicity: not teratogenic, no developmental toxicity in the rat (OECD TG 414); study Takawale, BSL, 100325, 2010, RL
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

- developmental toxicity/teratogenicity:

FAT 40841/A TE was nalaysed for it’s developmental toxicity/teratogenicity in a prenatal developmental toxicity study according to OECD TG 414. The study was conducted in pregnant female wistar rats to detect the possible adverse effect on pregnant females and embryofetal development when administered by oral gavage from gestation day 5 to 19.

Nulliparous and non pregnant females were mated with males (2:1 ratio) and divided into four groups based on their body weights on the day of sperm positive vaginal smears (GD 0). Four groups of presumed pregnant females were dosed daily by oral gavage with 0, 160, 400 and 1000 mg/kg bw per day of FAT 40841/A TE at dose volume of 10 mL/kg body weight. Control animals were handled identically as treated groups and received sterile water as a vehicle in similar volume as treated groups.

Statistically significant increase in group mean number of male fetuses in MD and HD group and sex ratio in HD group was observed when compared with controls. Group mean number of females was decreased in MD and HD group withought reaching statistical significance. Statistically significant increase in group litter mean weight and male litter weight was observed in MD and HD when compared with controls. There was also decrease in female litter weight observed in HD when compared with controls. Group mean number of males was increased in MD and HD and group mean number of females was decreased in MD and HD as compared to controls. Total number of fetuses remained unaffected in treated groups when compared with controls. Decrease in pregnancy rate was observed in control group (73.08%), LD (80.00%), and MD (80.77%) as compared to HD (92.00%). Statistically significant increase in incidence of incomplete ossification of 5th and 6th sternebra and significant decrease in incidences of ansent 4th metacarpal (bilateral) was observed in LD and HD resepectively. There was statistically significant decrease in kidney- hydronephrosis (Left) in LD and MD group. There was increased number of incidences of blue/green discolouration of various visceral organs observed in treated groups. All these effects were not related to substance toxicity.

In conclusion, the repeated dose administration of FAT 40841/A TE to pregnant female Wistar rats at dosages of 160, 400 and 1000 mg/kg bw 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 40841/A TE in wistar rats was 1000 mg/kg bw. Based on these study results a classification of FAT 40841/A TE for developmental toxicity/teratogenicity is not needed.

Toxicity to reproduction: other studies

Additional information

no data available

Justification for classification or non-classification

- fertility

As no data on adverse effects on fertility from a reproductive toxicity study 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. Absence of respective effects in a repeated dose study (oral, gavage) support a non-classification.

- developmental toxicity/teratogenicity:

Based on the above stated results on developmental toxicity FAT 40841/A TE does not need to be classified fort his endpoint 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.

Additional information