Z-85

Endpoint summary

Description of key information

In acute oral  and dermal toxicity studies in the rat, the LD50 was determined to be greater than 2000 mg/kg bodyweight. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Read-across to properties of an analog is applicable based on the similarity in structure and physico-chemical properties. The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.

Oral

The acute oral toxicity of this substance was evaluated in rats using the OECD 420 fixed dose method. Following acclimation, a sighting test at a dose level of 2000 mg/kg via gavage was conducted with one animal. Based on the absence of mortality, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed. 

Inhalation

According to REACH Annex XIII Section 8.5 information on acute toxicity will be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a solid with a vapour pressure of 0.012 Pa at 25°C and is used primarily as a component of lubricants and greases by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is, therefore, not required.

Dermal

In a Guideline study performed to OECD 402 and EC Method B3 on an analogue substance, a single dose of 2g/kg undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females). The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped gently with cotton wool moistened with distilled water to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The test sites were also examined for evidence of primary irritation and scored according to the Draize scale daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14.

No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed. 

The test article, when administered as received to male and female Sprague-Dawley rats, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight

Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute toxicity.

Justification for classification or non-classification

The acute toxicity of this substance was evaluated in rats using the OECD 420 fixed dose method for oral toxicity and OECD 402 for dermal toxicity . Based on the results of these studies, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute toxicity.