2-ethoxy-1,3-dimethylcyclohexane

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 423: LD50 > 2000 mg/kg bw
Acute dermal toxicity: OECD TG 402: LD50 > 2000 mg/kg bw

Acute inhalation toxicity: OECD 403: LC50 > 5.05 g/m3

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 020 mg/m³

Quality of whole database:

The acute inhalation toxicity result is of sufficient quality and adequate for this dossier.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The acute dermal toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

The study was performed according to OECD tg nO. 423 in Wistar strain rat.

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight.  Based on the results from this dose level, further groups of fasted females were treated at a dose level of 2000 mg/kg body weight.  Dosing was performed sequentially.

The test item was administered orally undiluted at a dose level of 2000 mg/kg body weight and as a solution in arachis oil BP at a dose level of 300 mg/kg body weight.  

There were no deaths and clinical observations included hunched posture that was noted 4 hours after dosing in one animal treated at a dose level of 2000 mg/kg.  There were no other signs of systemic toxicity noted. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight

Acute dermal toxicity:

In this study (conducted to OECD TG No.402), 10 rats (5 males and 5 females) were administered (single, 24 hour, semi-occluded dermal application) the substance at a dose level of 2000 mg/kg bw.

The rats showed no mortality, no clinical signs, no signs of dermal irritaiton, expected gains in body weight, no abnormalities at necropsy.

The acute dermal LD50 for the substance in male and female rats was determined to be greater than 2000 mg/kg bw.

Acute inhalation toxicity:

The study was performed to assess the acute inhalation toxicity of the test item, according to OECD TG No. 403 “Acute Inhalation Toxicity” and with Method B.2. Acute Inhalation Toxicity, 2014, of Commission Regulation (EC) No. 440/2008.

No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.05 mg/L for 4 hours. It was therefore considered that the acute inhalation median lethal concentration (4 hour LC50) of the test item in the Wistar strain rat was greater than 5.05 mg/L.

Justification for classification or non-classification

According to the criteria outlined in Annex I of Regulation (EC) No 1272/2008/EC (CLP), the substance does not have to be classified for acute toxicity by the oral, dermal and inhalation route.