Reaction mass of (4Z)-4-ethylidene-2-propoxycyclohexanol and (4E)-4-ethylidene-2-propoxycyclohexanol and (5Z)-5-ethylidene-2-propoxycyclohexanol and (5E)-5-ethylidene-2-propoxycyclohexanol

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 > 5.2 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:

5 200 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:

In this study (conducted to OECD TG No.423), 3 rats (females) were administered the substance at dose level of 300 mg/kg bw and 2 groups of 3 rats (females) were administered the substance at dose level of 2000 mg/kg bw.

The rats at 300 mg/kg bw showed no mortality, no clinical signs, expected gains in body weight, no abnormalities at necropsy.

The rats at 2000 mg/kg bw showed no mortality, expected gains in body weight, no abnormalities at necropsy. Hunched posture and ataxia were noted in the first group of animals treated at a dose level of 2000 mg/kg. Other signs of systemic toxicity noted in one of these animals were decreased respiratory rate, prostration and increased salivation. All animals in this group appeared normal 1 day after dosing.

No signs of systemic toxicity were noted during the observation period in the second group of animals treated at a dose level of 2000 mg/kg

The calculated acute oral LD50 for females was estimated to be greater than 2000 mg/kg bw.

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:

In a GLP-compliant acute toxicity inhalation study, performed according to OECD 403, toxicity of the test substance was examined. A group of five male and five female rats was exposed to a target concentration of 5 g/m³for 4 hours. Thereafter, the animals were kept for an observation period of 14 days before necropsy. To detect adverse effects, clinical observations were made during and after exposure, body weight was determined before exposure (days -1 and 0) and on days 1, 3, 7 and 14, and a gross necropsy was performed on all animals.

 

The mean actual concentration (± standard deviation) during exposure, based on gravimetric analysis of test atmosphere samples, was 5.20 (± 0.03) g/m³. The average mass median aerodynamic diameter (MMAD) of the particles in the aerosol was 3.83 (± 0.13) μm and the distribution of particle sizes had an average geometric standard deviation (GSD) of 1.86 (± 0.05). Mortality did not occur during the study; all animals survived until scheduled sacrifice at the end of the 14-day observation period. During exposure, breathing abnormalities were observed in all animals, characterized by a decreased breathing rate and shallow respiration. Male animals were generally affected more severely than females. Shortly after exposure, animals displayed breathing abnormalities (dyspnoea, sniffing and/or shallow breathing) and general signs of discomfort (e.g. ataxia, tremors, hunched posture, hypoactive behavior, piloerection). At the end of the day, the condition of the animals had improved and clinical abnormalities were less apparent. Over the course of the following days, the animals recovered from these abnormalities. Most animals showed a slight loss of body weight on the day after exposure (on average 5% in males and 1% in females), from which they recovered within the first week. Normal growth was observed in the second week of the observation period. Macroscopic examination at scheduled necropsy revealed hemorrhages in one or more lung lobes of one female and four male animals. No macroscopic lesions were found in the five remaining animals.

 

Based on the results of this study, it was concluded that the 4-hour LC50 of the test substance in rats is above 5.20 g/m³.

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 route, dermal route or inhalation route.