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Administrative data

Key value for chemical safety assessment

Effects on fertility

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:
Reliable screening study providing multiple endpoints.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No studies are available on the reproductive toxicity of C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine. Read-across from the substance to a repeated dose toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.

The effects of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine on fertility have been investigated in a combined repeated dose/reproductive screening toxicity study conducted according to OECD Test Guideline 422 (Perks, 2013). In the study groups of male and female Crl:WI(Han) rats (10 animals/group) were administered with the test substance orally by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day. Dose levels were selected based on the results of a 14-day range finding study. Male rats were dosed once daily for two weeks prior to pairing, during the pairing period and a further two weeks before necropsy. Males were treated for a minimum of 6 weeks prior to necropsy. Female rats were dosed for two weeks prior to pairing, during pairing and until Day 4 post-partum, inclusive at total of approximately 7 weeks. The females were allowed to litter and rear their offspring to Day 4 post-partum.

There were no treatment related deaths during the study. No treatment-related clinical signs, changes in bodyweight gains, histopathological changes or functional changes were observed in the study. The No-Observed-Adverse-Effect-Level (NOAEL) for the general or systemic toxicity in male and female rats was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested).

 

No developmental effects, effects on reproductive parameters or treatment-related signs of systemic toxicity were observed in the study. No treatment-related effects were observed on mating, fertility or fecundity indices; the majority of animals mated within one oestrous cycle. No treatment-related adverse effects were observed on gestational length, the number of implantation sites or pups born, pup survival or body weight gain. Pup necropsy data were unremarkable. Based on this study, the No-Observed-Adverse-Effect-Level (NOAEL) for the effects of the substance on fertility in male and in female rats and for developmental toxicity was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested).

Based on read-across to the findings of this study, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is not predicted to be a reproductive toxicant.

Read-across to the findings from a proposed 90-day repeated dose oral toxicity study and a pre-natal developmental toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine will provide a further characterisation of the reproductive hazard potential of C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine.


Short description of key information:
Based on existing datasets and structural ad chemical considerations, read-across from C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine to an available study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. In a combined repeated dose and reproduction/developmental toxicity screening test conducted in the rat according to OECD Test Guideline 422, no effects on reproductive paramaters were observed at doses upto 1000 mg/kg bw/day (i.e. the highest dose tested). The reproductive toxicity of the substance will be characterised further based on read-across to a proposed 90-day oral repeated dose toxicity study (OECD Test Guideline 408) and a prenatal developmental toxicity study (OECD 414) conducted using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine.

Justification for selection of Effect on fertility via oral route:
Based on existing datasets and structural and chemical considerations, read-across from C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine to an available study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. No evidence of an effect on reproductive parameters was seen in a combined repeated dose and reproductive/developmental screening study (OECD 422) in rats after repeated oral doses upto 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
Read-across to the findings of a proposed pre-natal developmental toxicity study (OECD Test Guideline 414) on Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is considered appropriate for the characterisation of the developmental toxicity hazard potential of C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine.
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
Additional information

No studies on the developmental toxicity of C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine are available. Based on existing datasets and structural and chemical considerations, read-across from the substance to studies using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.

No effects on developmental parameters were observed in a combined repeated dose and reproductive/developmental toxicity study conducted using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine following oral doses up to 1000 mg/kg bw/day (Perks, 2013). Based on this study, the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested)

Testing is proposed for a pre-natal developmental toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine (OECD Test Guideline 414). Read-across to the findings of this study is considered appropriate for the characterisation of the developmental toxicity of C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine

Justification for classification or non-classification

No classification is proposed: relevant data are not available.