Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts

Endpoint summary

Description of key information

ORAL
LD50 = > 15 mL/kg bw, male/female rat, Anonymous 1980
INHALATION
In accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute inhalation toxicity study required under information point 8.5.2 on the basis of exposure considerations. The nature of the registered substance means that it is not potentially inhalable.
DERMAL
In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute dermal toxicity study required under information point 8.5.3 of Annex VII on the basis of exposure considerations; no dermal absorption of the registered substance is expected to occur.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available study contains no data with regard to GLP; it was conducted to a methodology which is analogous to that of standardised guideline OECD 401. Since the report contains a sufficient level of detail to assess the quality of the relevant results, the study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997). The study was conducted on an analogous substance and therefore is considered as "read-across". Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

The acute oral toxicity of the test material was determined following a method similar to that outlined in the standardised guideline OECD 401. During the study, 5 Sprague Dawley rats of each sex were administered test material, by gavage, at dosage levels of 5, 10 and 15 mL/kg bw. Following dosing, animals were observed for a period of 14 days for signs of gross toxicological effects.

Under the conditions of the study, none of the animals died, no gross effects were noted and all animals gained weight. The acute oral LD50 of the test material was subsequently determined to be in excess of 15 mL/kg bw.

Inhalation

The nature of the registered substance means that it is not potentially inhalable; the substance has low vapour pressure and therefore is unlikely to be available for inhalation as a vapour. The low water solubility, high molecular weight and the log Pow value of >9.4 obtained for the structural analogue suggest a limited absorption after inhalation.

If any amount of the substance reaches the alveoli, this will be likely phagocytised by macrophages, located into the immune surveillance tissues and broken down in lysososmes and peroxisomes.

Dermal

The physical state, high molecular weight and log Pow value of >9.4 obtained for the structural analogue, together with the low water solubility, indicate very low potential for dermal absorption. Similarly to mineral oils, deposition in the stratum corneum is expected to occur slowly; however, the substance is not sufficiently water soluble to partition from the stratum corneum into the epidermis

As dermal absorption cannot be greater than oral absorption, and the estimate of 2% oral absorption is already a worst-case estimate, no dermal absorption of the registered substance is expected to occur.

Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for classification or non-classification

In accordance with with 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 acute oral toxicity study.