Propane-1,2-diyl dibenzoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 days minimum

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: New study performed to GLP and internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diyl dibenzoate

EC Number:

242-894-7

EC Name:

Propane-1,2-diyl dibenzoate

Cas Number:

19224-26-1

Molecular formula:

C17H16O4

IUPAC Name:

1-(benzoyloxy)propan-2-yl benzoate

Constituent 2

Reference substance name:

1,2-propan-diyl-dibenzoate

IUPAC Name:

1,2-propan-diyl-dibenzoate

Constituent 3

Reference substance name:

K-Flex®PG

IUPAC Name:

K-Flex®PG

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): K-FLEX® PG
- Substance type: Plasticizer
- Physical state: Colourless to pale yellow liquid
- Analytical purity: 97.1% propylene glycol esters
- Lot/batch No.: KAKPG43301
- Expiration date of the lot/batch: 05 March 2016
- Storage condition of test material: Ambient temperature

Test animals

Species:

rat

Strain:

other: Crl:CD (SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Reputable supplier
- Age at study initiation: 68 to 96 days
- Weight at study initiation: 378 - 419g (males), 259 to 292g (females)
- Housing: 3 per single sex cage
- Diet (e.g. ad libitum): Mouse No. 1 Maintenance Diet.
- Water (e.g. ad libitum): Potable water via sipper tubes
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 40
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01/05/2014 To: 27/05/2014

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Aerosol generator (stainless steel concentric jet atomiser) and a snout only exposure chamber.
- Exposure chamber volume: 30.0 litres
- Method of holding animals in test chamber: Restraints
- Source and rate of air: Compressed air at 20 litres/minute
- Method of conditioning air: Filter
- System of generating particulates/aerosols:
- Method of particle size determination: Marple Model 296 Personal Cascade Impactor
- Treatment of exhaust air: Filter
- Temperature and humidity in air chamber: Temperature 22.8 ºC ± 0.25 (SD), Humidity 43.5% ± 1.60 (SD).

TEST ATMOSPHERE
- Brief description of analytical method used: 4 hour acute inhalation toxicity LC50 testing.
- Samples taken from breathing zone: Yes

TEST ATMOSPHERE
- Particle size distribution: 77.5% ≤ 3.50µm, 100% ≤ 9.80µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):The mean MMAD value was within the ideal range of 1 to 4 microns indicating that the propylene glycol dibenzoate atmosphere was highly respirable to the rats.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.32 mg/L Propylene glycol dibenzoate (Mean) ± 0.099mg/L (SD), close to the target concentration of 5 mg/L.

No. of animals per sex per dose:

3 animals per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days minimum

- Frequency of observations and weighing: The animals were observed intermittently for signs of reaction to the test substance during
exposure (as well as1 and 2 hours after exposure) and at least twice daily throughout the observation period, on the day of termination observations were recorded in the morning only.. The weight of each animal was recorded once during the acclimatisation period and on Days 1 (prior to dosing) 2, 4, 8 and 15.

- Necropsy of survivors performed: Yes

- Other examinations performed: Clinical signs, body weight and macropathology.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.32 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

There were no unscheduled deaths.

Clinical signs:

other: During exposure - 1/3 females noted to have wet fur. Immediately after exposure - Chin rubbing evident for all animals (both male and female), all females were noted as having red staining of the head and wet fur. Clinical signs of wet fur and red stainin

Body weight:

Slight body weight losses were observed in 2/3 males and 3/3 females on the day following exposure. Growth was evident at the next weighing occasion (Day 4) for all animals.

Gross pathology:

The macroscopic examination performed after a single exposure followed by a 14 day observation period revealed no findings in any test animal.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the LC50 (4 hour) of propylene glycol dibenzoate is in excess of 5.32 mg/L for male and female rats.
Propylene glycol dibenzoate is unclassified, according to EU Regulation 1272/2008.

Executive summary:

Under the conditions of this study, the LC₅₀ (4 hour) of propylene glycol dibenzoate is in excess of 5.32 mg/L for male and female rats.

Propylene glycol dibenzoate is unclassified, according to EU Regulation 1272/2008.