Paraffin waxes and Hydrocarbon waxes, oxidized

Endpoint summary

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

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

The reproductive toxicity of the test material was determined in a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, performed according to OECD guideline 422.

Sprague-Dawley rats (10 per sex per dose) were given 54 consecutive doses of the test material, receiving 100, 300 or 1000 mg/kg/day. Both the adults and the F1 generation were observed during 54 day study and subjected to necropsy at termination. Examination of reproductive performance offspring litter sizes, sex ratios, reproductive and viability indices show that there is no evidence of reproductive toxicity in this study. One high dose female failed to achieve pregnancy and another female from this dose group was sacrificed at parturition due to dystocia. These are normal low incidental findings observed on reproductive studies and considered unrelated to treatment.

No treatment related effects were detected in reproduction, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for reproductive toxicity was considered to be 1000 mg/kg/day.

The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

The results of this read-across study can be considered to represent a worst case since the test material (Distillates (petroleum), oxidized light) is a shorter chain material and therefore has a greater potential for absorption within the body. The read-across substance can therefore be considered to be potentially more bioavailable than the registered substance, which, due to its very high log Pow value, is anticipated to have only very limited potential for bioavailability.

In accordance with Column 2 (adaptation statement) of Annex IX of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the two-generation reproductive toxicity study required under information point 8.7.3 if the substance is of low toxicological concern. The toxicological activity of the substance is negligible and the toxicokinetic assessment of the registered substance shows low potential for absorption.

Short description of key information:
NOAEL = 1000 mg/kg bw/day, male/female rat, OECD 422, Dhinsa (2005)

Justification for selection of Effect on fertility via oral route:
The oral route was considered the most appropriate route. Only one study was available.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. The study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

Effects on developmental toxicity

Description of key information

NOAEL = 1000 mg/kg bw/day, male/female rat, OECD 422, Dhinsa (2005)

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

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

The developmental toxicity of the test material was determined in a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, performed according to OECD guideline 422.

Sprague-Dawley rats (10 per sex per dose) were given 54 consecutive doses of the test material, receiving 100, 300 or 1000 mg/kg/day. Both the adult and the F1 generation were observed during 54 day study and subjected to necropsy at termination. All animals, including those dying during the study, were subjected to a full external and internal examination post parturition, and any macroscopic abnormalities were recorded.

No adverse effects or systemic signs of toxicity were recorded as a result of treatment during this study. One high dose female failed to achieve pregnancy and another female from this dose group was sacrificed at parturition due to dystocia. These are normal low incidental findings observed on reproductive studies and considered unrelated to treatment. No treatment related effects were detected in offspring growth or development, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for developmental toxicity was considered to be 1000 mg/kg/day.

The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

The results of this read-across study can be considered to represent a worst case since the test material (Distillates (petroleum), oxidized light) is a shorter chain material and therefore has a greater potential for absorption within the body. The read-across substance can therefore be considered to be potentially more bioavailable than the registered substance, which, due to its very high log Pow value, is anticipated to have only very limited potential for bioavailability.

In accordance with Column 2 (adaptation statement) of Annex IX of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the pre-natal toxicity study required under information point 8.7.3 if the substance is of low toxicological concern. The toxicological activity of the substance is negligible and the toxicokinetic assessment of the registered substance shows low potential for absorption.

Justification for selection of Effect on developmental toxicity: via oral route:
The oral route was considered the most appropriate route. Only one study was available.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. The study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the study.