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Key value for chemical safety assessment

Effects on fertility

Description of key information
No reproduction data is available on Tricyclodecane dimethanol dimethacrylate. However in the screening study on reproduction on an analogue substance (Tricyclodecane dimethanol diacrylate), the test substance was administered daily by oral gavage to male and female Sprague Dawley rats, for 2 weeks before pairing, during pairing, gestation and until day 5 p.p., at dose-levels of 100, 300 or 1000 mg/kg/day.
No adverse effect was observed in this study at any doses. Therefore, based on the experimental conditions of this study: the NOAEL for parental toxicity, the NOAEL for reproductive performance (mating and fertility) and the NOAEL for toxic effects on progeny were 1000 mg/kg/day.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
This screening test is considered to be reliable: study was performed according to guideline study and has 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

Screening reproduction study (Bentz 2015, OECD 421), read-across on analogue substance

The objective of this study was to evaluate the potential toxic effects of Tricyclodecane dimethanol diacrylate following daily oral administration (gavage) to male and female rats from before mating, through mating and, for females, through gestation until Day 4 post-partum (p.p.). This study provides initial information on male and female reproductive performance, such as gonadal function, mating behavior, conception, development of the conceptus and parturition.

Three groups of ten male and ten female Sprague-Dawley rats received the test item daily by oral (gavage) administration before mating, through mating and, for the females, through gestation until Day 4p.p.. The test item was administered as a solution in the vehicle, corn oil, at dose-levels of 100, 300 or 1000 mg/kg/day. Another group of ten males and ten females received the vehicle alone, under the same experimental conditions and acted as a control group. A constant dose-volume of 5 mL/kg/day was used.

Parental animals:There were no unscheduled deaths ascribed to test item treatment. Test item-related clinical signs were limited to ptyalism which was noted in several animals given 300 mg/kg/day and in all animals given 1000 mg/kg/day and was considered to be of minor toxicological relevance. There were no test item treatment-related effects on mean body weight, mean food consumption, mean organ weights and at macroscopic and microscopic examinations.

Reproduction parameters:There were no test item treatment-related effects on mating and fertility data, mean duration of gestation, mean number of corpora lutea, mean number of implantations, mean percentage of pre-implantation loss and mean number of pups delivered. At 1000 mg/kg/day, there was a trend towards a slightly high mean percentage of post-implantation loss (14.6%vs.6.9% in controls) due to 2/10 females; this effect was considered to be non-adverse because no effects on the mean number of pups per litter were observed.

Pups:There were no toxicologically significant effects on pup data (viability, mean body weight, sex ratio, macroscopic findings). A relationship of the clinical signs noted in one litter mainly (blackish abdomen, hypoactivity, cold to the touch and dehydration) with the test item treatment was considered to be doubtful.

Under the experimental conditions of this study:

- the No Observed Adverse Effect Level (NOAEL) for parental systemic toxicity and reproductive performance was considered to be 1000 mg/kg/day, based on the absence of adverse effects at all dose-levels,

- the NOAEL for toxic effects on progeny was considered to be 1000 mg/kg/day, based on the absence of adverse effects in pups at all dose-levels.

 

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 results available on Tricyclodecane dimethanol diacrylate (no effect on reproductive organs in male and female rats in the 28 -day repeated study, and no effects on the reproduction in the screening study), no classification for Tricyclodecane dimethanol dimethacrylate is required for reprotoxicity according to the Regulation EC n°1272/2008.