Dihexyl ether

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 26, 2018 - August 08, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

2009

Deviations:

no

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihexyl ether

EC Number:

203-987-8

EC Name:

Dihexyl ether

Cas Number:

112-58-3

Molecular formula:

C12H26O

IUPAC Name:

1-(hexyloxy)hexane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAGE Labs
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 330-362g (males) and 195-237g (females)
- Housing:c ages confromig to the size recommendations in the "Guide for the Care an Use of Laboratory Animals" (Natl. Res. Council, 2011)
- Diet (e.g. ad libitum): Envigo Teklad Global 16 % Protein Rodent Diet(R) #2016, ad libitum (except during exposure)
- Water (e.g. ad libitum): ad libitum (except during exposure)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-27 °C
- Humidity (%): 53-85 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: JUly 20, 2018 To: August 3, 2018

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

ca. 3.18 µm

Geometric standard deviation (GSD):

2.28

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-only inhalation chamber
- Exposure chamber volume: 28 l
- Method of holding animals in test chamber: animals were individually housed in polacarbonate holding tubes which seal to the chamber with an "O" ring during exposure
- Source and rate of air: filtered generator air
- Method of particle size determination: eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler
- Temperature, humidity, pressure in air chamber: 22 °C, 66-67 %, slight megative pressure

TEST ATMOSPHERE
- Brief description of analytical method used: Samples were colected using 37 mm glass fiber filters (Whatman(TM) GF/B) in a filter holder attached by 1/4 inch Tygon(R) tubing to a vacuum pump. Filter papers were weighed before and after collection to determine the mass collected. This value was devided by the total volume of air sampled to determine the chamber concentration. Sample airflows were measured using a Mass Flow Controller.
- Samples taken from breathing zone: yes

Duration of exposure:

4 h

Concentrations:

5.13 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
body weights: prior to test substance exposure and again on Days 1, 3, 7, and 14
observations during exposure: continuously
cage side observations: at least once daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.13 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 5.13 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

none

Clinical signs:

other: No signs of gross toxicity, adverse clincal effects or abnormal behaviour.

Body weight:

no effects on the body weight

Gross pathology:

no gross abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the consdition of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.17 mg/l in male and female rats.

Executive summary:

An acute inhalation toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the condition of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.17 mg/l in male and female rats.