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Key value for chemical safety assessment

Effects on fertility

Description of key information

Data is available for Toluene-4-sulphonohydrazide (TSH) on reproduction (fertility and development) from a recently performed OECD 422 study:


 


Toluene-4-sulphonohydrazide was given orally by gavage for a minimum of 28 days to Wistar Han rats, evaluating male and female reproductive performance such as gonadal function, mating behaviour, conception, parturition and early postnatal development. In addition, parental, reproduction (up to and including implantation) and developmental (from implantation onwards) No Observed Adverse Effect Levels (NOAELs) were evaluated. The dose levels in this study were selected to be 0, 4, 10, 25 mg/kg/day, based on the results of the Dose Range Finder. The rats of the control group received the vehicle, propylene glycol, alone.


 


No reproductive toxicity was observed up to the highest dose level tested (25 mg/kg bw/day). No treatment-related changes were noted in any of the reproductive parameters investigated in this study (i.e. mating and fertility indices, precoital time, number of implantations, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs).


 


 


 


 


 

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Klimisch score 1, the study was performed in accordance to OECD 422, and in compliance with GLP regulation.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Data is available for Toluene-4-sulphonohydrazide (TSH) on reproduction (fertility and development) from a recently performed OECD 422 study:


 


Toluene-4-sulphonohydrazide was given orally by gavage for a minimum of 28 days to Wistar Han rats, evaluating male and female reproductive performance such as gonadal function, mating behaviour, conception, parturition and early postnatal development. In addition, parental, reproduction (up to and including implantation) and developmental (from implantation onwards) No Observed Adverse Effect Levels (NOAELs) were evaluated. The dose levels in this study were selected to be 0, 4, 10, 25 mg/kg/day, based on the results of the Dose Range Finder. The rats of the control group received the vehicle, propylene glycol, alone.


 


No developmental toxicity was observed up to the highest dose level tested (25 mg/kg/day). No toxicologically significant changes were noted in any of the developmental parameters investigated in this study (i.e. gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight, anogenital distance, areola/nipple retention, T4 thyroid hormone levels and macroscopic examination). 


 


At 25 mg/kg/day, slightly lower body weights were recorded for male and female pups from PND 1 onwards, being 9% lower at PND 13 (combined for both sexes). The lower body weights were considered adverse at this early stage in development, also based on the magnitude of the effect recorded at the end of lactation. Lower body weights recorded at 10 mg/kg/day from PND 1 onwards had essentially recovered on PND 13, and were therefore considered not to be adverse.


 


Based on the available results form this OECD 422 study, a NOAEL for of 10 mg/kg/day (based on lower pup body weights at 25 mg/kg/day) was concluded for developmental toxicity. 

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Species:
rat
Quality of whole database:
Klimisch score 1, the study was performed in accordance to OECD 422, and in compliance with GLP regulation.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

 


 


 


 

Justification for classification or non-classification

Based on the available data from a recently performed OECD 422 study, no classification of TSH is concluded for fertility or developmental effects.

Additional information

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