Cyclohexane, 1,4-bis(ethoxymethyl)-

Endpoint summary

Description of key information

Acute oral toxicity:
- OECD 423: LD50 > 2000 mg/kg bw
Acute toxicity via inhaltion
- OECD 423: LC50 > 5.2 mg/L
Acute dermal toxicity
- OECD 402: LD50 > 2000 mg/kg bw

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 adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

oral:

In an acute oral toxicity study performed according to the Acute Toxic Class method according to OECD 423 (BASF SE, 2013, 10A0766/12X374), doses of 2000 mg/kg bw of the test item Cyclohexane, 1,4-bis(ethoxymethyl)- (undiluted) were administered to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females) by gavage in a sequential manner. No mortality occurred. The following test substance-related clinical observations were recorded: impaired general state (6/6), piloerection, (6/6), salivation (6/6), cowering position (3/6), dyspnoea (3/6), apathy (2/6), stagger (1/6), exophthalmos (1/6). There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period. The mean body weight of the surviving animals increased within the normal range throughout the study period, with the exception of one female (first test group), which showed stagnation of body weight during the second post-exposure week. The acute oral LD50 was calculated to be > 2000 mg/kg bw.

inhaltion:

To determine the acute inhalation toxicity (single 4-hour exposure, nose only) of 1,4-bis(ethoxy-methyl)-Cyclohexane as a liquid aerosol, a study was performed in male and female Wistar rats according to OECD-Guideline method 403, as well as EC and EPA

guidelines. The actual measured concentration was 5.207 mg/L (analytical concentration, limit test). Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) of 2.3 and 2.2 μm, which are well within the respirable range.

No mortality occurred at the tested concentration. Clinical signs of toxicity comprised of red encrusted nose, abdominal respiration indicating local irritation effect. Moreover, piloerection and substance contaminated fur. The effects were observed after exposure until the study day 1. No clinical signs and findings were observed from study day 2 onwards. The mean body weights of the animals decreased on the first post exposure observation day but increased thereafter. No gross pathological abnormalities were detected during the necropsy in the animals at the termination of the study. Under the current study conditions, the LC50 value was > 5.2 mg/L (calculated based on analytical concentration) in male and female Wistar rats after 4 hour inhalation exposure to liquid aerosol of 1,4-bis(ethoxymethyl)-Cyclohexane 97%.

dermal:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item 1,4-bis(ethoxymethyl)-Cyclohexane 97%. The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10% of the total body weight surface) was covered by semi-occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days. No mortality occurred. Neither signs of systemic toxicity nor local skin effects were observed. The body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in all animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw

Justification for classification or non-classification

The present data on acute oral toxicity do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.