2-phenylhexanenitrile

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

In a dietary reproscreening study (OECD TG 421) a NOAEL >70 mg/kg bw/d for males and > 80 mg/kg bw for females (the highest dose tested) has been derived at which no effects on fertility have been found, resulting in an overall NOAEL for fertility of at least 70 mg/kg bw.

In addition, in the 28-day repeated dose toxicity study no effects on male or female gonads were observed indicating the absence of fertility effects (NOAEL > 250 mg/kg bw).

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Quality of information is adequate because the information on fertility is available from the 28-day repeated dose toxicity study and the repeated dose reproscreen study, both according to the respective OECD guidelines under GLP, supporting the absence of effects for fertility.

Additional information

A reproscreen study according to OECD TG 421 has been conducted for the substance. Nominal values of 200, 400 and 1000 ppm have been administered via the diet. Chemical analysis showed mean accuracies of 67%, 71% and 77% for the diets of Groups 2, 3 and 4, respectively, which was below the criterion range 80-120%. Therefore the analysed concentrations were used for determining the doses resulted in circa 15, 30 and 70 to 73 mg substance/kg body weight/day for the males and 79 to 124 mg substance/kg body weight/day for the females. No toxicologically significant parental toxicity was observed up to the highest dose level tested. In the males liver weights were slightly increased but without microscopic changes. Therefore the liver effects were considered to be of an adaptive nature to administration of the test substance. No fertility toxicity was observed up to 70 mg/kg bw. Therefore a parental and fertility NOAEL of at least 70 mg/kg bw was established.

Effects on developmental toxicity

Description of key information

The developmental toxicity of Salicynalva was tested in a developmental / reproscreen study according to OECD TG 421 using dietary exposure. The exposure resulted in doses of circa 15, 30 and 80 mg/kg bw for dams. The dams showed no toxicologically significant effects up to the highest dose level tested. The increased liver weights at the highest dose was not accompanied with macroscopic or microscopic changes and were therefore considered to be an adaptive response to the test substance. No developmental toxicity was observed up to the highest dose tested. Treatment with Salicynalva by dietary administration in female Wistar Han rats at dose levels of circa 15, 30 and 80 mg/kg bw did not reveal maternal and developmental toxicity for treatment up to the highest dose. The No Observed Adverse Effect Level (NOAEL) of at least 80 mg/kg bw was established based on the actual test substance intake 79 to 124 mg substance/kg body weight/day for the dams.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The quality of the developmental reproscreen study is adequate because it has been performed according to the respective OECD guideline under GLP.

Justification for classification or non-classification

Based on the absence of effects on fertility in a reproscreening study, Salicynalva does not have to be classified as toxic to reproduction according to EU CLP (EC No. 1272/2008 and its amendments).

Based on the absence of effects on developmental toxicity in a reproscreen study, Salicynalva does not have to be classified as toxic for developmental toxicity according to EU CLP (EC No. 1272/2008 and its amendments).