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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
sec-butyl chloroformate
EC Number:
241-475-6
EC Name:
sec-butyl chloroformate
Cas Number:
17462-58-7
Molecular formula:
C5H9ClO2
IUPAC Name:
butan-2-yl carbonochloridate
Constituent 2
Reference substance name:
sec.- butylchloroformate
IUPAC Name:
sec.- butylchloroformate
Constituent 3
Reference substance name:
87/0122
IUPAC Name:
87/0122
Details on test material:
- Name of test material (as cited in study report): sek.Butylchlorformiat ( sec-butyl carbonochloridic acid ester) - Physical state: clear liquid - Analytical purity: > 99 % - Expiration date of the lot/batch: not reported - Stability under test conditions: ca. 12 month- Storage condition of test material: ca. 5°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Dr. K. Thomae GmbH, Biberach, D- Age at study inition: 8-9 weeks- Weight at study initiation: males 275 +- 25.3 g; females 191 +- 12.5 g- Diet (e.g. ad libitum): KLIBA Labordiaet Ratte/Maus 24 343-4 10 mm Pellet, Klingentalmuehle AG, Kaiseraugst, CH- Water (e.g. ad libitum): tap waterENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%): 30 - 70- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- Exposure apparatus: The vapour was produced by a constant infusion pump coupled with a glas evaporator with a thermostat.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
determined by GC
Duration of exposure:
4 h
Concentrations:
analytical: 0.44 mg/L; 2.33 mg/L nominal: 0.64 mg/L; 2.70 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: weighing was performed at the beginning of the study and on d 7 and d 14; observations were performed serveral times on the day of exposure and at least once per work day- Necropsy of survivors performed: yes
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.44 - < 2.33 mg/L air
Exp. duration:
4 h
Mortality:
All animals of the high dose group died within 24 h. No mortality observed in the low dose group.
Clinical signs:
other: In both groups: At the beginning, eyelid closure, squatting posture, accelerated respiration, followed by irregular/ intermittent respiration, reduced startle reaction, anemic.Additionally in the high dose group: aqueous eye and nose discharge, salivation
Body weight:
Mean body weight gain of the low dose group was slightly reduced in the first observation week, but comparable to the reported historical control data in the second week.
Gross pathology:
Died animals: lung edemaSacrificed animals: nothing abnormal found

Applicant's summary and conclusion

Executive summary:

The study is conducted according to the OECD Guideline 403 and is reliable with out any restriction.

5 male and female Wistar rats were exposed to 0.44 and 2.33 mg/L sec.-Butylchloroformate for 4 h. No animal died at 44 mg/L. The acute LC50 of sec.-Butylchloroformate is > 0.44 and < 2.33 mg/L after inhalative exposure for 4 h. Squatting posture and irregular respiration were seen even in the low dose group, where no mortality appeared.

Conclusion:   

According to the results of the present study, the test substance sec.-Butylchloroformate has to be regarded as toxic after single inhalative exposure (R 23 according to EU classification requirements; acute inhalative Cat. 2 according to GHS requirements).