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Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

The test item, Licowax R 21 S FL (formulated in Refined Ground Nut Oil) was administered by gavage to three treatment groups, each oftwelve male and twelve female Wistar rats, for up to 42 days. Males were treated for two weeks premating phase, up to two weeks mating and post-mating, females for two weeks premating phase, up to two weeks mating, three weeks gestation and 13 days lactation at dose levels of 100, 300 and 1000 mg/kg bw/d. A control group of twelve males and twelve females was dosed with the vehicle control (refined ground nut oil).

Results:

1. Mating and fertility

No treatment-related effects were detected on mating performance. All the female animals of control, low, intermediate and high dose groups showed positive evidence of mating. No significant difference was observed in the pre-coital interval of female animals between control, low, intermediate and high dose group.Oestrous cyclicity was checked for all the female animals. Regular oestrous cycle was observed in all the animals of different groups in the study.Mating index for all groups was 100%.

One dam each from control, intermediate and high dose group was observed to be not pregnant.The pregnancy index for Control -0, Low-100, Intermediate-300 and high dose -1000 mg/kg/day groups were observed 100%.

Of the litters born, litter sizes at birth and subsequently on days 1 and 4 post partum were comparable to control

There were no treatment-related effects observed in fertility of treated animals.

2. Gestation and parturition

There were no differences in gestation lengths. The gestation length for treated females was comparable to controls. All animals showed gestation lengths between 20 to 24 days.

The parturition index was 91.67 % in control; intermediate dose and high dose groupwhereas in intermediate dose it was observed 100.00 %.

3. Pre and post natal loss

The pre and post natal losses in all treated groups were comparable with findings in the control group whereas marginal decrease and increase in percentage post implantation loss was observed in the low dose group and high dose group, respectively. No dose response relationship was observed.

4. Litter size and live birth

Of the litters delivered, in all the treatment groups, litter size at birth and subsequently on Day 1 and 4 post-partum were comparable to controls. No significant difference in the live birth was noted between control and treated groups.No nipple retention was found in any of the male litter from vehicle control, low, intermediate and high dose groups.

5. Sex ratio

No significant difference in sex ratio was observed in any of the treated groups when compared with vehicle control.

6. Offspring growth and development

Offspring body weights were recordedon day 1, day 4 and 13 were recorded. No significant changes in the offspring body weight were observed in Low (G2- 100 mg/kg body), intermediate (G3- 300 mg/kg body) and high dose group (G4- 1000 mg/kg body) when compared with control (G1- 0 mg/kg body) group.

No significant differences in theAnogenital distances (AGD) between control and treated animals were observed

7. Litter weights

Offspring body weightson day 1, day 4 and 13 were recorded. No significant changes in the offspring body weight were observed.

No toxicologically relevant findings were noted in thyroxine (T4) and thyroid stimulating hormone (TSH) levels in parent animals (males, females) and pups (male and female).

Based on the results of the OECD 422 study performed with Liccowax R21 S the NOAEL (reproduction/developmental) is derived at 1000 mg/kg bw/d.

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 without restriction

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

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

There is no evidence to suggest that a classification for reproductive toxicity is appropriate.

With reference to the OECD 422 studies performed with the registration substance, it is concluded that the test item is not subject to classification and labelling according to Regulation 1272/2008/EC regarding reproductive toxicity.