Reaction mass of glycerol 1,3-di(acetate) and glycerol acetate and triacetin

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:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions. Lack of details on the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

lack of details on the test substance

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triacetin

EC Number:

203-051-9

EC Name:

Triacetin

Cas Number:

102-76-1

Molecular formula:

C9H14O6

IUPAC Name:

propane-1,2,3-triyl triacetate

Details on test material:

- Name of test material (as cited in study report): Triacetin
- Chemical denomination: 1,2,3-Propantriol-triacetat
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Wistar Bor: WISW (SPF-Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 160-220 g
- Housing: animals were housed in groups of 5 per Makrolon type III cage.
- Diet: Altromin 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindric inhalation chamber with a baffle
- Exposure chamber volume: 20 L
- Method of holding animals in test chamber: restraining tube for head/nose-only exposure
- Source and rate of air: a compressed air supplying device (600 kPa) delivered the air at a rate of 10 L/min
- Method of conditioning air: continuous infusion pump
- System of generating particulates/aerosols: 200 µL/minute of the test substance were dispersed into the chamber
- Method of particle size determination: Aerodynamic Particle Sizer with Laser-Velocimeter (TSI-APS 3300)

TEST ATMOSPHERE
- Brief description of analytical method used: GC (FI-detector) to measure the test substance concentration (mg/m³ air)
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 100 % of the particles were ≤ 5µm
- 1054845 particles per ccm
- MMAD: 1.69 µm

Time to chamber equilibration (t95): 6 minutes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

20 mg/L (nominal concentration)
1.7 mg/L (analytical concentration)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Body weights: the animals were weighed before exposure and weekly thereafter.
- Necropsy of survivors performed: yes

Statistics:

mean values were calculated

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 721 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.721 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 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 14-day observation period.

Body weight:

No effect on body weight was noted.

Gross pathology:

There were no local irritation of the visible mucous membranes of the respiratory tract.

Other findings:

Air-exposed negative control animals showed no clinical symptoms during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified