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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No reproduction data is available on 1,10 decanediyl bis methacrylate.

However, a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD Guideline 422 is available on an analogue substance of 1,10 decanediyl bis methacrylate,1,4-Butanediol dimethacrylate.

On the basis of the results obtained in this study, the NOAEL (No Observed Adverse Effect Level) for both systemic and reproduction toxicity is considered to be 300 mg/kg/day for males and females.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
the study is considered to be reiliable with a klimisch score of 1.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD Guideline 422 (22 March 1996) 1,4-Butanediol dimethacrylate was administered to 10 Hsd: Sprague Dawley SD rats/sex/dose orally by gavage at dose levels of 0 (control), 100, 300 and 1000 mg/kg bw/d. The treatment schedule included 2 weeks before pairing, during pairing, post coitum and post partum periods up to day 3 post partum. Animals were administered for approximately 5 and 8 weeks for males and females, respectively.

 

No mortality occurred in the study. A total of 8 females were found not pregnant at necropsy: one each in the control and low dose groups and 6 in the high dose group.
The number of females with live pups on Day 4 post-partum were: 9 in the control group, 9 in the low dose group, 10 in the mid-dose group and 4 in the high dose group.
No clinical signs of toxicological significance were reported.

Body weight and body weight gain were lower in the high dose group compared to controls throughout the study.
Food consumption was reduced in the high dose group compared to controls.No relevant differences were noted in all parameters investigated between control and treated groups.
No changes of toxicological significance were found.
The main relevant change was an increased value of bile acids in treated groups compared tocontrols with a clear dose-relation in males.
No changes were recorded in urinalysis.
Measurements of oestrus cycle, pre-coital intervals and copulatory index did not show differences between treated and control groups. On the contrary, fertility index was markedly reduced in the high dose group (40% compared to 90% of the control group).
No significant differences were observed in the number of implantation, corpora lutea, total litter size, pre-implantation loss, pre-birth loss and gestation length between control and treated groups.
Reduced litter and mean pup weights were found in the high dose group compared to controls. The percentage of cumulative pup loss on Day 4 post partum starting from the total litter size at birth, was increased in the high dose group.
No differences were found in sex ratio between the groups.
Small pups were generally observed in all groups including the control group. Cold to touch and apparently no food intake were the signs noted in pups of the treated groups only.
No relevant differences were recorded in decedent pups between the groups.
No abnormalities were observed in pups sacrificed at term.
Terminal body weight was lower in the high dose group compared to controls and this difference was statistically significant in females.
Statistically significant higher kidneys weight was observed in high dose males and females
compared to controls. In addition, thymus weight was significantly decreased in high dose males.
No treatment-related changes were noted at macroscopic examination.
Treatment-related findings at microscpopic observations were limited to the high dosed animals and were seen in the stomach of both sexes and in the liver of the females only.Stomach (non-glandular)
The treatment-related change seen in the high dosed animals (1/10 and 5/10, respectively in males and females), consisted of mild diffused hyperplasia of the squamous epithelium in the non-glandural stomach, which was associated with mild thickening (i.e., hyperkerathosis) of the keratin layer. This change was not associated with any indication of inflammation and/orulceration.
In 3/10 high dose animals (females), minimal degree of multifocal perilobular hepatocytic vacuolaiton, which is suggested to be consistent with fatty change, was noted. The vacuoles were of mixed type (i.e., micro- and macrovesicular) and no presence of inflammation and/ornecrosis was noted.
Evaluation of the spermatogenic cycle did not show differences between the groups. Regular layering in the germinal epithelium was noted.

 

On the basis of the results obtained in the study, the NOAEL (No Observed Adverse Effect Level) for both general toxicity and reproduction/developmental toxicity could be considered 300 mg/kg/day for males and females.The pronounced reduction of body weight gain of the premating animals indicates that the reduced reproduction success is likely a secondary effect of general systemic toxicity resulting in a poor condition of the parent females.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, no classification is required for reproduction toxicity according to the Regulation EC No. 1272/2008.