Bis(2-ethylhexyl) azelate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles. Test substance purity not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

purity of test substance not given, 10 male and female animals used per test group, 5 males and females sacrificed one day after exposure, only 2 concentrations were tested

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Bis(tridecyl) adipate

EC Number:

241-029-0

EC Name:

Bis(tridecyl) adipate

Cas Number:

16958-92-2

IUPAC Name:

ditridecyl adipate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Analytical purity: not given
- Expiration date of the lot/batch: 01-01-1990
- Storage condition of test material: room temperature under ventilation

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River at Kingston, USA
- Age at study initiation: 10 weeks
- Weight at study initiation: 310 g - 387 g (male), 205 g - 268 g (female)
- Housing: in individual stainless steel wire cages during exposure, when not exposed housed in cages which conform to AALAC standards
- Diet: certified Purina rodent chow #5002, ad libitum except during exposure
- Water: tap water delivered via automatic system, ad libitum, except during expsoure
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08-02-1988 To: 30-06-1988 and 01-07-1988

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 400 L
- System of generating particulates/aerosols: Aerosol was generated by use of Laskin nebulizers. Pressurized air passed through the hollow site of the nebulizer and exited at high velocity through holes in its side. This high velocity airstream passed over the top of hollow feed barrels and caused the aspiration of the liquid test material up into the feed barrel. The liquid was aerosolized as it is drawn into the airstream by the relative negative pressure there. The liquid was sheared into small droplets. The larger aerosol particles were removed by impaction on the walls of a glass container around the nebulizer and by impaction in a secondary glass impactor. The aerosol was diluted by the main airstream before entering the exposure chamber. The flask containing the nebulizer for the high dose was partially submerged in water maintained at about 40°C in order to maximize the aerosol concentration.

TEST ATMOSPHERE
- Brief description of analytical method used: Concentration of aerosol in the chamber was determined gravimetrically by drawing known volumes of air from the chamber through glass fiber filters and measuring the increase in weight of the filters. the weigth increase was divided by the volume of air sampled to give the aerosol concentration.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (see table1)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gas Chromatography

Duration of exposure:

4 h

Concentrations:

0.5, 5.0 mg/L (3.2 mg/L was the highest practical concentration which could be achieved, as determined by analytical verification instead of 5 mg/L)

No. of animals per sex per dose:

10 (5 animals of each sex sacrificed one day after exposure)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days, 5 males and 5 females of each group were sacrificed 1 day after exposure
- Frequency of observations and weighing: weighing on day 1, 2, 8 and 16, observations for mortality and toxic signs were carried out daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

body weight: ANOVA and Tukeys multiple range test for comparison of control and exposed groups
organ weights: ANOVA and Duncans multiple range test in the Grosse Software System

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.2 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed.

Clinical signs:

other: No treatment-related toxicologically significant signs were noted.

Body weight:

Body weight was not affected by exposure.

Gross pathology:

No treatment-related effects were found.

Other findings:

- Organ weights: Organ weights were not affected by treatment.
- Histopathology: No treatment-related microscopic changes were observed in any of the organs examined (lungs, nasal turbinates, liver, kidney, tracheobronchial lymph node).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified