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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Concise report, but method provided, no GLP, similar to OECD Guideline 403
Justification for data waiving:
other:
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:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
5 animals
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
not yet introduced
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): Santicizer 141
- Physical state: liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: mature
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: metal chamber of 35-liters capacity
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 54
- 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: Air flow through the sample was 4.0 l/m as measured by a calibrated rotameter
- Method of conditioning air:
- System of generating particulates/aerosols: a concentrated atmosphere of vapors was produced by passing a stream of air through 140.0 grams of the test compound contained in a 250-ml erlenmeyer flask. The sample was maintained at a temperature of 162.7 °C by immersing the flask in a heated sand bath. Vapors from the flask passed into a one liter bottle to remove droplets and then into the chamber.
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 23 °C, 54%, pressure unknown.

TEST ATMOSPHERE
- Brief description of analytical method used: The test system is exposed to a concentrated atmosphere of the vaporized test material. Amount of Sample: To start: 140.0 grams; Recovered: 135 0 grams; Total vaporized: 5.0 grams (3.6%); Recovered from condenser: 2.0 grams (1.4%); Weight of vapors entering chamber: 3.0 grams (2.2%)
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 6 h
Concentrations:
2.1 mg/l (nominal, calculated from data)
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: 1 to 2 hours; 3 to 4 hours; 5 to 6 hours during exposure. Day 1, 2, 3, 5, 8, and 10 during observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 2.1 mg/L air
Based on:
test mat.
Remarks:
Total weight vaporized minus recovered from condenser
Exp. duration:
6 h
Mortality:
3 out of 5 animals died (one on day 3, one on day 5 and one on day 8 of observation period)
Clinical signs:
Observations during exposure:
1 to 2 hours: Animals appeared unaffected
3 to 4 hours: Lethargy, slight nasal discharge, slow reflexes
5 to 6 hours: Slight ocular discharge, labored breathing, and tremors in some animals
Observations during ten day period following exposure:
Upon removal from the chamber there was evidence of bronchial rales, poor equilibrium, and roughening of the fur.
1st Day - Outward appearance normal
2nd Day - Reduced appetite and weakened condition in all
Body weight:
On the 10th day of observation two surviving animals showed 30 to 40 % weight loss.
Gross pathology:
Autopsy of the succumbed animals #3 and #4 showed hemorrhagic areas of lungs, light liver discoloration, and gastrointestinal inflammation {yellowish slime in intestines). Animal #5 showed lung congestion, liver discoloration, and acute gastrointestinal inflammation. Surviving animals were sacrificed ten days following exposures. Macroscopic examination revealed congestion of lungs; otherwise the viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All animals survived the 6 hour exposure period; 3 of 5 test animals succumbed during the 10 day observation period. It was concluded that the vapors were harmful under conditions of the test. The LC50 was calculated to be 2.1 mg/l for 6 h exposure. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 141 needs to be classified as harmful by inhalation.
Executive summary:

The acute inhalation toxicity of Santicizer 141 towards rats was investigated in a test similar to OECD Guideline 403. Five male rats were exposed to Santicizer 141 at a concentration of 2.1 mg/l for 6 hours. The procedure is designed to provide a single inhalation exposure at an elevated temperature 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 10 days. All animals survived the 6 hour exposure period; 3 of 5 test animals succumbed during 10 day observation period. It was concluded that the vapors were harmful under conditions of the test. The LC50 was calculated to be 2.1 mg/l (nominal concentration) for 6 h exposure. Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS) Santicizer 141 needs to be classified as harmful by inhalation.