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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:
26 November 1979 - 19 December 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Concise report, but method provided, and tested under early GLP, but no guideline followed.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Six male Sprague-Dawley Albino rats were exposed to Sancticizer 154 at a concentration of 0.4 mg/l for 6 hours. The procedure is designed to provide a single inhalation exposure at an elevated temperature (145 °C) to a concentrated atmosphere of the vaporized test material for potential toxic effects. Signs of intoxication and mortality are observed during the observation period of 14 days.
GLP compliance:
yes
Remarks:
early GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Santicizer 154
- Physical state: liquid
- Impurities (identity and concentrations): confidential
- Composition of test material, percentage of components: confidential
- Lot/batch No.: confidential
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Younger Laboratories Inc.
- Age at study initiation: young adult
- Weight at study initiation: 200 - 300 grams
- Fasting period before study: no data
- Housing: 35 liter stainless steel chamber fitted with a one-liter condensation flask. The chamber has a glass window for viewing animals during exposure. Following the exposure period, the animals (survivors) are returned to preassigned individual cages.
- Diet: ad libitum following exposure - Rodent Laboratory Chow #5001 - Meal
- Water: ad libitum following exposure
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 55
- Air changes (per hr): air flow rate: 4 L/min.
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Exposure chamber volume: 35 L.
- Method of holding animals in test chamber: no data
- Source and rate of air: room air at the rate of four liters per minute (regulated by a calibrated rotameter) is bubbled through the sample, through the condensation flask to remove droplets, and then into the chamber
- Method of conditioning air:
- System of generating particulates/aerosols: An oil bath of size sufficient to immerse container with test material as well as a thermometer along side the sample container to measure internal temperature of the heated bath is used to maintain the required elevated temperature (145°C). A thermostatically controlled hot plate to used to preheat and maintain the oil bath at the temperature specified in the protocol. The oil bath is preheated and allowed to stabilize prior to start of test. Temperature of bath is recorded throughout exposure period.
- Treatment of exhaust air: via tygon and glass tubing
- Temperature, humidity, pressure in air chamber: 25 °C, 55%, pressure unknown.

TEST ATMOSPHERE
- Brief description of analytical method used: The test system is exposed to a concentrated atmosphere of the vaporized test material. Sample material is weighed into suitable container (which has been previously weighed and weight recorded). Total weight (sample and container) is recorded. The container with sample is then immersed in the preheated oil bath along side the thermometer. At the end of the exposure period, container and remaining sample (sample not vaporized) are weighed and weight recorded. Condensation flask is weighed previous to and following exposure with weights recorded. Weight of condensate, if any, is recorded (by difference), Sample vaporized is the difference in the sample weight (less weight of container), final and initial, less amount of sample condensed. Sample concentration (sample vaporized during exposure period) will be reported as mg/l of air.
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 6 h
Concentrations:
0.4 mg/l
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals are weighed on test day prior to exposure, and at intervals during the observation period (including one and seven days after exposure, and at sacrifice (fourteen days after exposure) and at prior death.
Animals are observed for mortality and toxic signs during exposure period, immediately following exposure (when removed from the chamber), frequently on the day of exposure, and once daily thereafter for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: toxic signs, body weight
Statistics:
Statistical method of calculation: Sample concentration (sample vaporized during exposure period) will be reported as mg/l of air:
liters of air/grams of sample vaporized = mg/l

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.4 mg/L air
Based on:
other: vaporized sample
Exp. duration:
6 h
Mortality:
No mortality occured
Clinical signs:
No toxic signs. Viscera appeared normal.
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

Initial sample: 103.8 g; recovered sample: 103.1 g. Recovered sample: light straw color. Condensed sample 0.0 g.Vaporized sample: 0.7 g.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, the LC50 was found to be > 0.4 mg/l for 6 h. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 154 does not need to be classified and has no obligatory labelling requirement for inhalation toxicity.
Executive summary:

The acute inhalation toxicity of Santicizer 154 towards rats was investigated. Six male Sprague-Dawley Albino rats were exposed to Santicizer 154 at a concentration of 0.4 mg/l for 6 hours. The procedure is designed to provide a single inhalation exposure at an elevated temperature (145 °C) to a concentrated atmosphere of the vaporized test material for potential toxic effects. Signs of intoxication and mortality are observed during the observation period of 14 days. No toxic signs were found. Viscera appeared normal. No mortality occurred. Under the conditions of this test, the LC50 was found to be > 0.4 mg/l for 6 h. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 154 does not need to be classified and has no obligatory labelling requirement for inhalation toxicity.