Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 January 2007 to 18 January 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): MTDID 9580
- Substance type: Clear colorless liquid
- Physical state: Liquid
- Analytical purity: 99%
- Purity test date: 15 November 2006
- Lot/batch no.: CM 16F176
- Expiration date of the lot/batch: 31 December 2007
- Storage condition of test material: At room temperature in the dark, under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 10 weeks old
- Weight at study initiation: Males: 355-401 g, Females: 245-277 g
- Fasting period before study: None
- Housing: 5 animals per sex per cage in Macrolon type IV cages.
- Diet (e.g. ad libitum): Pelleted rodent diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7-22.5
- Humidity (%): 38-59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 04 January 2007 To: 18 January 2007

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The exposure chamber was based on the flow past nose-only inhalation chamber. The chamber consisted of 3 animal sections with 8 animal ports each.
- Exposure chamber volume: No Data
- Method of holding animals in test chamber: Restraining tubes.
- Source and rate of air: 2.0 L/min
- Method of conditioning air: Air was passed through a vessel containing water for humidification
- System of generating particulates/aerosols: A vapor was generated in a vertical elutriator by nebulization of the test substance by means of a stainless steel nebulizer operating under 2.4 bar air pressure.
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 20.3 C, 23-34%, no pressure data.
TEST ATMOSPHERE
- Brief description of analytical method used: A stream of the test atmosphere was drawn from the exposure chamber and led through a gas cell which was mounted in an infra red spectrophotometer.
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Remarks:
A stream of the test atmosphere was drawn from the exposure chamber and led through a gas cell which was mounted in an infra red spectrophotometer.
Duration of exposure:
ca. 4 h
Concentrations:
20.8 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made three times during exposure and once daily thereafter. Animals were weighed on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 20.8 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
No mortality occured.
Clinical signs:
No adverse clinical signs were noted.
Body weight:
The mean body weight gain observed in the animals during the study period was considered to be similar to the expected gain of untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found upon macroscopic necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on the results of the study, the 4-hour inhalation LC50 of the test article is greater than 20.8 mg/L, vapor.
Executive summary:

The acute inhalation toxicity potential of the test article was evaluated in male and female Wistar rats following OECD guideline 403 (1996) “Acute Inhalation Toxicity.” The test article was administered to rats (5/sex) at a concentration of 20.8 mg/L by nose-only inhalation for 4 hours. Clinical observations were recorded three times during exposure and at 1 and 3 hours after dosing (day 1), then daily thereafter through day 15. Body weights were recorded on days 1, 8 and 15. Animals were euthanatized on day 15 and a necropsy was performed for macroscopic abnormalities. No clinical signs of systemic toxicity were observed. Chromodacryorrhoea (red, stress-related eye secretion) was noted on the head of two males at 1 and 3 hours after exposure. There were no toxicologically relevant changes in body weights and body weight gain. No abnormalities were found by macroscopic examination at necropsy. Based on the results of the study, the 4-hour inhalation LC50 of the test article is greater than 20.8 mg/L, vapor.