Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 January 2012 to 28 January 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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 30531
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.5%
- Purity test date: 01 October 2012
- Lot/batch No.: IOFH-AH221-ANL1200052

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 186-200 g
- Fasting period before study: None
- Housing: group housed in standard solid-bottom plastic cages with bedding
- Diet (e.g. ad libitum): Harlan Teklad Rat/Mouse 2018 Diet (Harlan Teklad, Madison, WI) ad libitum
- Water (e.g. ad libitum): Tap Water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-23.9
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 January 2012 To: 28 January 2012

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: 40 liter plexiglass chamber mixed by means of a recirculating pump connected to opposite sides of the chamber via a loop of stainless steel tubing.
- Exposure chamber volume: 40 liters
- Method of holding animals in test chamber: Animals were whole body exposed whithin the chamber
- Source and rate of air: No data
- Method of conditioning air: No data

TEST ATMOSPHERE
- Brief description of analytical method used: Exposure chamber test article concentrations were measured approximately every 5 minutes during each exposure period using a gas chromatographic-electron capture detector (GC-ECD) method. Samples were taken from the recirculating airstream.
- Samples taken from breathing zone: Samples were taken from the recirculating airstream.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 1 h
Concentrations:
0, 91.0, and 862.9 ppm
No. of animals per sex per dose:
3 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations (during, immediately after, and 2 hours following exposure, daily thereafter) and body weights (Days 1, 8 and 15) were noted.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 6.25 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
All animals survived to scheduled necropsy.
Clinical signs:
other: Animals in the 863 ppm (12.49 mg/L, vapor) group exhibited slightly increased activity, slight ataxia, and in one animal occasional gasping during exposure. Animals in the 91 ppm (1.32 mg/L, vapor) group exhibited slightly increased respiration rates duri
Body weight:
Body weight gains were normal in all animals.
Gross pathology:
No gross lesions were observed in any animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the 4 -hour equivalent LC50 of the test article is greater than 431.5 ppm (6.25 mg/L, vapor).
Executive summary:

The acute inhalation toxicity of the test article (Clear and colorless to pale pink liquid, Purity 98.2%, Lot: IOFH-AH221-ANL1200052) was evaluated in Sprague Dawley rats. The study was not conducted under GLP conditions. The test method was based OECD Guideline 403 (1981). The test article was administered as a vapor. Male rats (3/group) were exposed, whole body, to the test article at 91 ppm (equivalent dose 1.32 mg/L) or 863 ppm (equivalent dose 12.49 mg/L) and for a single, 1 hour exposure. Clinical observations (for 2 hours after exposure and daily thereafter) and body weights (prior to exposure and on Days 8 and 15) were recorded. Limited necropsy was performed on all animals on Day 15, no organs or tissues were collected. All animals survived to scheduled necropsy. Animals in the 863 ppm group exhibited slightly increased activity, slight ataxia, and in one animal occasional gasping during exposure. Animals in the 91 ppm group exhibited slightly increased respiration rates during exposure. Clinical signs post-exposure were normal in all animals. Body weight gains were normal in all animals. No gross lesions were observed in any animals at necropsy. Based on the results of the study, the 4-hour equivalent LC50 of the test article is great than 431.5 ppm (6.25 mg/L, vapor).