Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1987

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:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

fixed concentration procedure

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:

C21H44O6

IUPAC Name:

Decanoic acid, mixed diesters with octanoic acid and propylene glycol

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: young
- Weight at study initiation: 285 - 465 g

Administration / exposure

Route of administration:

inhalation: mist

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Each group of guinea pigs was placed in a 75 liter chamber equipped with an air supply of 10 liters per minute. After the test animals became accustomed to the chamber conditions, the test item was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm. Particle counts were performed every 30 minutes using Bausch and Lomb particle counter (model 40-1A). The chamber temperature was recorded every 30 minutes. The control group was exposed to only air for the same length of time.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

6 h

Concentrations:

200 ppm (equivalent to 5952 mg/m³)

No. of animals per sex per dose:

200 ppm: 6 male, 6 female
control: 3 animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Effect levels 2

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Mortality:

No animals died or were sacrificed in moribund condition.

Clinical signs:

other: No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period.

Gross pathology:

In the necropsies and microscopic examination no changes in the animals were detected, which could be related to the treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation study on guinea pigs over 6h the LC50 was above 200 ppm (equivalent to 5952 mg/m³):

Executive summary:

An acute inhalation study on guinea pigs over 6h with the test item was performed. The concentration of 200 ppm was prayed into the air supply for 12 guinea pigs (6 male, 6 female). After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).