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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction:

NOAEL was considered to be 55.0 mg/kg bw/day while LOAEL was determined to be 188.0 mg/kg/day on the basis of effects in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT) when F344 male rats were exposed to chloral hydrate for 52 weeks.

Based on the above data it can be concluded that the effects was observed in percentage of motile sperm but it was on very high concentration and in a chronic study. No compound related effects on fertility of parent animal was observed. Also considering the Harmonised classification of target, it can be concludedthat the substance Chloral hydrate is not reproductive toxic in nature.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
55 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
The data is of K2 level and is obtained from peer-reviewed journal.
Effect on fertility: via inhalation route
Species:
rat
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxicity to reproduction:

Following studies of Chloral Hydrate were reviewed for toxicity to reproduction from reliable sources having Klimisch rating 2.

In a key reproductive toxicity study, F344 male rat were exposed to chloral hydratein the concentration of 0, 55.0 and 188.0 mg/kg/day by oral drinking water for 52 weeks ( Reproductive Toxicology, Vol. 9, No. 6. pp. 571-578, 1995). No significant effect were observed on clinical sign, body weight, organ weight, gross pathology and histopathology but significant decrease were observed in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT). In addition, Mean straight-line velocities average path and straight-line velocity distributions were shifted to a lower modal velocity range in 188.0 mg/kg/day treated rat as compared to control. Therefore,NOAEL was considered to be 55.0 mg/kg bw/day while LOAEL was determined to be 188.0 mg/kg/day on the basis of effects in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT) when F344 male rats were exposed to chloral hydrate for 52 weeks.

In a Screening test for reproductive / developmental toxicity, obtained from IPCS monograph 2000, male and female CD-1 mice were exposed to chloral hydrate in drinking-water at 21.3 or 204.8 mg/kg body weightper day. Animals were exposed for 3 weeks prior to breeding. Exposure of females (5 per group) continued during gestation and until pups were weaned at 21 days of age. No gross malformations were noted, and no significant effects were observed in duration of gestation, number of pups delivered, pup weight, or number of stillborn pups. All pups(15 per group) showed the same rate of development and level of performance on several neurobehavioural tests, except that pups exposed to 204.8 mg/kg body weight per day when tested at 23 days of age showed impaired retention of passive avoidance learning on both the 1-h and 24-h retention tests (P < 0.05). This study identified a NOAEL for neurodevelopmental toxicity of 21.3 mg/kg body weight per day and a LOAEL of 204.8 mg/kg body weight per day based on the impairment in passive avoidance learning. This study also identifies a NOAEL for reproductive and other developmental effects. The NOAEL for reproductive and other developmental effects of chloral hydrate on CD-1 mice were observed to 204.8 mg/kg body weight per day.

Based on the above data it can be concluded that in key study the effects was observed in percentage of motile sperm but it was on very high concentration and in a chronic study. No compound related effects on fertility of parent animal was observed. Also considering the Harmonised classification of target, it can be concluded that the substance Chloral hydrate is not reproductive toxic in nature.

 

Justification for classification or non-classification

Based on the above data it can be concluded that in key study the effects was observed in percentage of motile sperm but it was on very high concentration and in a chronic study. No compound related effects on fertility of parent animal was observed. Also considering the Harmonised classification of target, it can be concluded that the substance Chloral hydrate is not reproductive toxic in nature.