Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Data available on CAS 68477-54-3 (Low Dicyclopentadiene Resin Oil), CAS 68478-10-4 (Dicyclopentadiene/Codimer Concentrate) and on the specific components benzene, 1,3–butadiene, isoprene, toluene, naphthalene, styrene and C8 aromatics (xylenes and ethylbenzene) do not reveal effects on fertility and none are classified for this endpoint.

CAS 68477-54-3 (Low Dicyclopentadiene Resin Oil): In a combined repeated dose toxicity/reproduction/developmental toxicity study in rats there was no evidence of adverse effects on any measures of reproductive function. At 375 mg/kg/day clinical signs of toxicity, lower body weight and food consumption and histopathological changes were observed in adults. In addition, effects on body weight, clinical signs and food consumption were observed in males at 125 mg/kg/day. The NOAEL for reproductive toxicity was 375 mg/kg/day (the highest dose tested) (DuPont, 2004a).

CAS 68478 -10 -4 (Dicyclopentadiene/Codimer Concentrate): Following oral dosing at 0, 5, 25 or 100 mg/kg/day during premating (approximately 2 weeks), gestation (approximately 3 weeks), and lactation through day 4 no evidence of adverse effects on any measures of reproductive function were seen. There were no test substance-related effects on mean pup weight, number of pups born, number of pups born alive, sex ratio, gestation index, clinical observations, or litter survival for postnatal days 0-4 in the offspring from any dosage group. The NOAEL for reproductive toxicity was 100 mg/kg/day (the highest dose tested) (DuPont, 2004b).


Short description of key information:
Limited reproduction toxicity data are available for 2 streams within this category (CAS 68477-64-3: Low Dicyclopentadiene Resin Oil; CAS 68478-10-4: Dicyclopentadiene/Codimer Concentrate). In OECD Guideline 422 study no evidence of impaired fertility was seen. Data on the reproductive toxicity of specific components present in some streams indicate that none possesses specific effects which warrant labelling. Therefore, Resin Oils and Cyclic Dienes are considered not to have adverse effects on fertility and no labelling is warranted.

Effects on developmental toxicity

Description of key information
The specific developmental toxicity data on streams within this category are limited to general toxicity and reproduction/developmental toxicity screening studies (OECD 422) by oral (gavage) exposure to rats to CAS 68477-54-3 (Low dicyclopentadiene resin oil) and CAS 68478-10-4 (Dicyclopentadiene/Codimer Concentrate). These studies showed no evidence of teratogenicity. For CAS 68477-54-3 (Low Dicyclopentadine Resin Oil) lower pup body weight was seen at maternally toxic doses. Data on the developmental toxicity of specific components present in some streams indicate that only toluene is labelled with respect to developmental toxicity. Therefore, classification and labelling with respect to developmental toxicity will be driven by the concentration of toluene in Resin Oils and Cyclic Dienes streams.
Additional information

Data available on CAS 68477-54-3 (Low Dicyclopentadiene Resin Oil), CAS 68478-10-4 (Dicyclopentadien/Codimer Concentrate) and on the specific components benzene, 1,3–butadiene, isoprene, naphthalene and C8 aromatics (xylenes, ethylbenzene) indicate no hazard with respect to developmental toxicity and no labelling is warranted. Toluene is labelled for possible developmental toxicity:

CAS 68477-54-3 (Low Dicyclopentadiene Resin Oil): A combined repeated dose toxicity/reproduction/developmental toxicity study in rats showed no evidence of teratogenicity at any dose tested. Gestation length, implantation site numbers, implantation efficiency, mean number of pups per litter, percent of pups born alive, day 0-4 viability of pups, viability index, number of corpora lutea, sex ratio, pre-implantation loss, and post-implantation loss were comparable to controls. Maternal toxicity characterised by lower body weight and/or weight gain was observed throughout the dosing period at 375 mg/kg/day. There was no evidence of teratogenicity at any dose tested. Pups from the 375 mg/kg/day group had slightly lower body weight on day 4. The NOAEL for maternal and developmental toxicity was 125 mg/kg/day (DuPont, 2004a).

CAS 68478-10-4 (Dicyclopentadien/Codimer Concentrate):Female rats were dosed at 0, 5, 25 or 100 mg/kg/day during premating (approx 2 weeks), cohabitation (approx 2 weeks), gestation, and lactation (4 days). Gestation length, implantation site numbers, implantation efficiency, mean number of pups per litter, percent of pups born alive, day 0-4 viability of pups, viability index, number of corpora lutea, sex ratio, pre-implantation loss, and post-implantation loss were determined. Maternal toxicity at 25 and 100 mg/kg/day comprised histopathogical changes to the thyroid. There was no evidence of teratogenicity at any dose tested. The NOAEL for maternal toxicity was 5 mg/kg/day and for developmental toxicity was 100 mg/kg/day (DuPont, 2004b).

Toluene (Classification: EU – Harmful Xn, R63; GHS/CLP – Category 2, H361d): There is no evidence that toluene produces malformation in animals or humans. There is some evidence of developmental toxicity (lower body weight at birth and delayed vaginal opening) at toluene exposure concentrations ≥ 1000 ppm, concentrations which are associated with slight maternal toxicity. The NOAEC for developmental and maternal effects is 600 ppm (2261 mg/m3) (Thiel and Chahoud, 1997).

Justification for classification or non-classification

Data available the streams CAS 68477-54-3 (Low Dicyclopentadiene Resin Oil), CAS 68478-10-4 (Dicyclopentadiene/Codimer Concentrate) and on component substances indicate that streams within this class that contain less than 5% (EU/DPD) or 3% (GHS/CLP) toluene are not reproductive toxicants and do not require a label for this endpoint.

Resin Oils and Cyclic Dienes streams which contain ≥ 3% toluene should be classified "Suspected of damaging the unborn child" Category 2, H361d according to Reg (EC) 1272/2008. Resin Oils and Cyclic Dienes streams that contain ≥ 5% toluene are classified "Possible risk of harm to unborn child" Xn, R63, according to Dir 1999/45/EC.