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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
-reliability scoring based on 2009 guideline.
Deviations:
yes
Remarks:
-Purity, source, and physico-chemical properties of test substance not reported; 2 concentrations tested; oxygen and carbon dioxide concentrations were not provided; no individual data for clinical examination results
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Sprague-Dawley rats, Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht HAGEMANN GmbH & Co., D-4923 Extertal 1.
- Age at study initiation: 49 to 50 days at the start of quarantine.
- Weight at study initiation: 224-248 g (males); 195-213 g (females).
- Fasting period before study: Food was discontinued approximately 16 hours before exposition.
- Housing: Groups of 2 or 3 in MAKROLON cage (type III).
- Diet (e.g. ad libitum): Standardized diet for rats ALTROMIN 1324 (supplied by ALTROMIN GmbH, D-4937 Lage/ Lippe), ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 50± 10
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A dynamic inhalation apparatus with a nose only exposure of the animals according to KIMMERLE & TREPPER (Supplier: RHEMA-LABORTECHNIK, D-6238 Hofheim/Taunus). The apparatus consists of a cylindrical exposure chamber which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: A maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
- Source and rate of air: 400 L/h; source not reported.
- Method of conditioning air: A mixture of test substance and air was obtained using a spray-jet. The spray-jet was fed with compressed air (5.0 bar) from a compressor and with the test article using an infusion pump and a 50 mL syringe. At the bottom of the exposure chamber the air was sucked off at the same flow rate as created by the spray-jet in order to produce a homogenous distribution in the exposure chamber.
- System of generating particulates/aerosols: The test substance is at room temperature of volatile nature. The vapour pressure for the test substance is approximately 0.49 bar (49 kPa) at 20°C. This resulted in an almost complete gas phase in the inhalation chamber after the test substance air mixture escaped from the spray-jet.
- Method of particle size determination: Not applicable (vapor test).
- Treatment of exhaust air: Not reported.
- Temperature, humidity, pressure in air chamber:
Temperature 22±3°C; humidity and pressure not reported.


TEST ATMOSPHERE
- Brief description of analytical method used: Two air samples were drawn from within the inhalation chamber close to the nose of the animals and analysed by gas chromatography.
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Analytical concentrations: 1.94 and 6.54 mg/L air
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed continuously during and following the exposure time and during the recovery period, all possible findings were recorded systematically; individual records were maintained for each animal. On the day of exposure, observations were performed immediately, 5, 15, 30, and 60 minutes, 3 and 24 hours after end of exposure.
During the recovery period, careful clinical examination was conducted at least once a day until all symptoms had subsided, thereafter each working day. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals to the study, e.g., necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals.
Cage-side observations included, but were not limited to, changes in the skin and fur, the eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity as well as behavioural pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep, and coma. Individual body weights of the animals were determined before the exposure and after exposure in weekly intervals. Surviving animals were weighed at study termination and were sacrificed afterwards.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: see above
Statistics:
Not reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 6.54 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: No intolerance reactions were seen at the highest concentration of 6.54 mg/L. No pathological findings.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.54 mg/L air (analytical)
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
other: Lowest toxic concentration
Effect level:
> 6.54 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
No mortality occurred.
Clinical signs:
No substance-related intolerance reactions were observed.
Body weight:
Not reported
Gross pathology:
Macroscopic inspection revealed no pathological findings.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute toxicity, Cat. 4, H332