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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1985-05-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
not specified
Test type:
traditional method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-iodo-2-propynyl butylcarbamate
EC Number:
259-627-5
EC Name:
3-iodo-2-propynyl butylcarbamate
Cas Number:
55406-53-6
Molecular formula:
C8H12INO2
IUPAC Name:
3-iodoprop-2-yn-1-yl butylcarbamate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 21.274A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, N. Y.
- Age at study initiation: approx. 7 weeks
- Housing: individually in stainless-steel- wire-mesh cages
- Diet: ad libitum during non exposure periods
- Water: ad libitum throughout non exposure periods, via automatic water supply
- Acclimation period: three weeks quarantine

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 25.5 °C
- Humidity: 31 - 46 %
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 100 L
- Total chamber airflow: 16.7 L/min
- System of generating particulates/aerosols: Dust by use of a Wright Dust Feeder
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
6.89 mg/L
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The appearance and behavior of all animals were observed every 30 minutes during exposure, Immediately following the exposure, and twice dally during the 14-day postexposure period. Body weights of all animals were recorded immediately prior to exposure and on Days 2, 3, 4, 7, and 14 postexposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.89 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
One female in the treatment group was found dead on Day 5 post exposue.
Clinical signs:
other: At one hour of exposure, all animals exhibited dyspnea, salivation and rhinorrhea; these persisted throughout the exposure period. All animals showed lacrimation as well during the last one and one-half hours of exposure. During the 14-day postexposure pe
Body weight:
The mean body weights of all groups had increased by Day 14. However, the mean body weights of both sexes in the treated group declined from Day 2 postexposure through Day 4 postexposure.
Gross pathology:
Gross observations of animals necropsied at terminal sacrifice included dilatation of renal pelvis(es), pelvis fluid filled, dark red pinpoint foci 1n kidneys, and enlarged cervical lymph nodes. Incidences of these were more frequent in females than males.
Observations at necropsy of the Group 2 female found dead (Day 5 postexposure) showed findings in the spleen, intestines, stomach, lung, and nares.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute inhalation LD50 of the test item was considered to be greater than 6.89 mg/L air. However, clinical signs during exposure and post exposure were noted as well as a declined body weight in the treated group between day 2 and day 4 postexposure.
Executive summary:

In this study, the test item was applied to male and female rats for a 4 h exposure period by inhalation. Only one female rat was found dead on day 5 post exposure. Observations at necropsy showed findings in the spleen, intestines, stomach, lung, and nares. At one hour of exposure, all animals exhibited clinical signs as dyspnea, salivation and rhinorrhea; these persisted throughout the exposure period. All animals showed lacrimation as well during the last one and one-half hours of exposure. During the 14-day postexposure period, some of the predominant clinical signs were bloody crusts (nose/eyes/mouth/chest/ears), rough haircoat, thin, languid, wheezing, and urine stains. Generally, onset of a majority of these observations was at Day 4 except for bloody crust about the nose which were first noted after removal from the exposure chamber. Four of the five males were normal in appearance by Day 13 postexposure; all surviving females were normal in appearance on Day 11. The mean body weights of all groups had increased by Day 14. However, the mean body weights of both sexes in the treated group declined from Day 2 postexposure through Day 4 postexposure.

Gross observations of animals necropsied at terminal sacrifice included dilatation of renal pelvis(es), pelvis fluid filled, dark red pinpoint foci in kidneys, and enlarged cervical lymph nodes. Incidences of these were more frequent in females than males.