Registration Dossier

Administrative data

Description of key information

No repeated toxicity data is available on Tricyclodecane dimethanol dimethacrylate.

However a read-across with an analogue substance is proposed for this endpoint.

Under the experimental conditions of the OECD 407, following daily administration of Tricyclodecane dimethanol diacrylate for 4 weeks by oral route to male and female Sprague-Dawley rats at dose levels of 100, 300 or 1000 mg/kg/day in corn oil, the No Observed Adverse Effect Level (NOAEL) was considered to be at 1000 mg/kg/day in absence of adverse effects at this dose.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The 28-d study is considered to be reliable with a klimisch score of 1.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

Additional information

28 -d study (rat, gavage, OECD 407) ; read-across with analague substance

Three groups of five male and five female Sprague-Dawley rats received the test item, Tricyclodecane dimethanol diacrylate, by daily oral administration for 28 days at dose-levels of 100, 300 or 1000 mg/kg/day. The test item was administered as a solution in the vehicle (corn oil) at a constant dosage-volume of 5 mL/kg/day. A control group of five males and five females received the vehicle alone under the same experimental conditions.

There were no unscheduled deaths, no test item-related clinical signs or effects at the Functional Observation Battery including motor activity. There were no toxicologically significant effects on mean body weight, mean body weight change or mean food consumption.

Males treated at 1000 mg/kg/day had a mean neutrophil count and a mean urine pH lower than controls (0.91vs.1.54 G/L and 6.0vs.6.7, respectively, p<0.05) that were considered to be of limited toxicological significance.

In females treated at 1000 mg/kg/day, mean glucose and cholesterol levels were higher than in controls (6.85vs.6.02 mmol/L and 1.80vs.1.45 mmol/l, respectively, p<0.05) which were considered to be of minimal toxicological significance.

Increased absolute and relative-to-body liver weights were seen in females at 100, 300, and mostly at 1000 mg/kg/day. These differences correlated with microscopic non adverse increased vacuolation of periportal hepatocytes noted in these females at 100, 300 and 1000 mg/kg/day. Vacuolated hepatocytes were also observed in two males given 1000 mg/kg/day.

Under the experimental conditions of this study, following daily administration of the test item for 4 weeks by oral route to male and female Sprague-Dawley rats at dose levels of 100, 300 or 1000 mg/kg/day in corn oil, the No Observed Adverse Effect Level (NOAEL) was considered to be at 1000 mg/kg/day in absence of adverse effects at this dose.

Justification for classification or non-classification

Based on the 28 -day study, no severe organ toxicity was showed in rats treated with Tricyclodecane dimethanol diacrylate. No classification is required for the repeated toxicity for Tricyclodecane dimethanol dimethacrylate according to the Regulation EC n°1272/2008.