Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
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:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 721 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
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:
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.

Any other information on results incl. tables

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