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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
publication
Title:
Comparative acute toxicity and primary irritancy of various classes of amines
Author:
Myers R.C., Ballantyne B.
Year:
1997
Bibliographic source:
Toxic Substance Mechanisms, 16:151-193

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
2009
Deviations:
yes
Remarks:
Only females and two exposure concentrations tested
Principles of method if other than guideline:
- Principle of test:
A constant exposure time of 4 h was used and the concentration of test material in the chamber air was varied. The test material pumped into the top of a vertical glass evaporator tube, which was heated sufficiently to cause vapourization. Dried air was introduced through the bottom of the tube (countercurrent to the sample flow) and the resultant vapour-containing atmosphere passed to a 9-L exposure chamber. Chamber concentrations were determined by adjustment of sample and/or air flow rates.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Charge No.of test material: 01067
- Identification: TK 2527
- Source: Chemicals and Plastics, South Charleston

FORM AS APPLIED IN THE TEST (if different from that of starting material): Vapour

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 9L
- The sample was metered into heated vaporizer through which a metered flow of N2 gas was maintained. The resultant vapor was then diluted with air and oxygen to produce a oxygen concentration of 20.9%
- Temperature in air chamber: 25°C
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
4000 and 8000 ppm
No. of animals per sex per dose:
6 (females only)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of exposure and daily thereafter.
- Frequency of weighing: just before exposure and at sacrifice
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LC50
Effect level:
5 700 ppm
95% CL:
4 600 - 7 000
Exp. duration:
4 h
Remarks on result:
other: equivalent to 17.3 mg/l air
Mortality:
8000 ppm: 6/6 (3 animals within exposure, 1 animal after 2.5 h, 2 animals after 24 h).
4000 ppm: 0/6
Clinical signs:
other: 8000 ppm: gasping, nasal irritation, poor coordination, bloody nasal discharge, tonic convulsions. 4000 ppm: wet noses, eyes partly closed within 10 min, slight loss of coordination within 25 min.
Body weight:
The surviving animals gained weight.
Gross pathology:
Dead animals: lungs red, intestines yellow, gas and liquid filled
Survivors: no remarkable findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the available study results, the test item provokes inhalative toxic effects after a 4 hour vapour exposure period in rats. The mean lethal concentration was calculated to be 17 mg/L (5700 ppm).
Executive summary:

Acute inhalation toxicity was analyzed in a study performed with female Wistar rats. The animals were dosed with 4000 and 8000 ppm of vapourized test substance. After a 4 h exposure to 8000 ppm of the vapour all animals were dead within 24 h. No deaths occurred for the low level exposure scenario. Based on these observations a LC50 of 17.3 mg/L (5700 ppm) was calculated.

Main clinical signs observed after 8000 ppm vapour inhalation were gasping, nasal irritation, poor coordination, bloody nasal discharge and tonic convulsions.

Wet noses, partly closed eyes and a slight loss of coordination were observed for animals exposed to 4000 ppm of the vapour. At necropsy, dead rats showed gas and liquid filled red lungs and yellow intestines. Surviving rats were without remarkable finding at necropsy. Based on the estimated LC50, the test substance can be categorized for inhalative toxicity cat. 4 based on GHS criteria.