1,4-Dioxaspiro[4.5]decane, 2-(chloromethyl)-8-(1,1-dimethylethyl)-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according EU/OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane

EC Number:

601-507-5

Cas Number:

118135-28-7

Molecular formula:

C13H23ClO2

IUPAC Name:

8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0, 35, 447 and 5969 mg/m³ air.

No. of animals per sex per dose:

five male and five female animals per test group

Control animals:

yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LC50

Effect level:

> 5 969 mg/m³ air (analytical)

Exp. duration:

4 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

> 5 969 mg/m³ air (analytical)

Exp. duration:

4 h

Any other information on results incl. tables

Clinical signs

A complete listing of the intensity and time-dependence of the observed signs is presented in

the Appendix. A qualitative description, for the signs of importance in toxicological evaluation,

is given below.

Groups 0 and 35 mg/m³ air: No signs observed.

Group 447 mg/m³ air: Piloerection, bradypnea.

Group 5969 mg/m³ air: Reduced motility, piloerection, ungroomed coat, bradypnea, labored breathing, staggering and high-stepping gait, hunchback posture, reduced responsiveness, dropping of eyelids, wet coat in the muzzle/neck area. One female rat died during exposure, which was considered to be technically-exposure related (death due to asphyxiation as a result of an irreversible head rotation in the exposure tube) rather than regarded to be a substance induced effect.

Reflex measurements

The observed statistically significant changes were not considered to be exposure related and therefore lexicologically relevant due to a lack of a clear concentration dependency.

Body weights

No significant depressions were noted from any of these groups on any subsequent observation period.

Animals sacrificed at the end of the observation period: Specific exposure related findings were not observed. Except for some minor lesions in the lung of one male animal of the 35 gm/m³ air (lung with isolated dark-red to brownish foci), all survivors showed no macroscopic alterations.

Animal that died during the exposure period: The animal that died during exposure probably due to asphyxiation showed minor macroscopic alterations (red-bluish discoloration of lung, marbled kidneys), which were considered to be of no lexicological importance.