Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

- 28 Apr 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted in 2009

Deviations:

yes

Remarks:

duration of exposure 6 h, purity of the test material not specified, only male animals were used, limited reporting details.

Principles of method if other than guideline:

At the time of study conduct in 1978, no guideline was available yet.

GLP compliance:

no

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

EC Number:

271-516-3

EC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Cas Number:

68583-51-7

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

BLU:(SD) BR Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY, USA
- Age at study initiation: young adults
- Weight at study initiation: 145 - 195 g
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum

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: 75 L
- Method of particle size determination: every 30 min using a Bausch and Lomb particle counter (model 40-1A)

- Each group of rats was placed in a 75 L chamber equipped with an air supply of 10 L per minute. After the test animals became accustomed to the chamber conditions, the material was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm.
- The chamber temperature was recorded every 30 min.
- The control group was exposed only to air for the same length of time.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Particle counts were performed every 30 min using a Bausch and Lomb particle counter (model 40-1A)

Duration of exposure:

6 h

Concentrations:

200 ppm
equal to 2.916 mg/L air (MW = 356.55 g/mol)

No. of animals per sex per dose:

3 (control group), 10 (test substance group)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: all major tissues and organs were preserved and the lungs and grossly abnormal organs were examined microscopically.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LC50

Remarks:

rat

Effect level:

> 2.916 mg/L air (nominal)

Based on:

test mat.

Remarks:

aerosol

Exp. duration:

6 h

Remarks on result:

other: based on a molecular weight of 356.55 g/mol

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Remarks:

rat

Effect level:

> 200 ppm

Based on:

test mat.

Remarks:

aerosol

Exp. duration:

6 h

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.

Gross pathology:

Necropsy examination revealed no substance-related findings.

Any other information on results incl. tables

According to the authors, respirable particles of the test material (≤ 5 µm) were produced.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The available data did not indicated an acute inhalation toxicity potential of the test substance in rats.