Cyclohexane, 1,4-bis(ethoxymethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to current guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay Labor für biologische Analytik GmbH

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane

EC Number:

700-868-7

Cas Number:

54889-63-3

Molecular formula:

C12 H24 O2

IUPAC Name:

(1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane

Details on test material:

- Name of test material (as cited in study report): Cyclohexane, 1,4-bis(ethoxymethyl)-
- Physical state: Liquid / colorless, clear
- Analytical purity: 99.6 corrected area-%
- Batch No.: 10474-11-115
- Expiration date of the batch: July 26, 2014
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rat / Wistar / Crl:WI (Han) SPF, Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 - 11 weeks
- Weight at study initiation: 184 - 198 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.23 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1. administration: 3 females (2000 mg/kg bw)
2. administration: 3 females (2000 mg/kg bw)

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
A check for any dead or moribund animals was made at least once each workday.
Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: first test group 2000 mg/kg bw: - Two animals showed impaired general state and piloerection from 1 hour until 5 hours after administration. The third animal showed impaired general state and piloerection only at hour 1 after administration. - All three

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The present data on acute oral toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.