Fatty acids, C16-18, esters with diethylene glycol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

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)

Deviations:

yes

Remarks:

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

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

Molecular formula:

Not applicable as UVCB.

IUPAC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Test animals

Species:

rat

Strain:

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 (controls), 10 (test substance groups)

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

Sex:

male

Dose descriptor:

LC50

Effect level:

> 200 ppm

Based on:

test mat.

Exp. duration:

6 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

> 2.916 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

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

Effect levels 3

Sex:

male

Dose descriptor:

LC50

Effect level:

> 4.3 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: extrapolation based on Haber´s law (please refer to "Any information on results incl. tables")

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

Particle size:

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

Extrapolation to 4 h exposure ( according to Regulation (EC) 1272/2008 and Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance (ECHA, 2008):

Considering Haber’s Law (C.t = k), a time-extrapolated LC50 value of 4.3 mg/L is achieved (2.916 [mg/L] x 6 h = c [mg/L] x 4h). As the extrapolated LC50 value is close to the defined cut off value of 5 mg/L, and no hazardous properties were identified in the conducted study, the available data are considered as conclusive but not sufficient for classification in regard to acute inhalation toxicity.

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