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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
Study period:
28 January 1980 - 22 February 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Although a subacute study is not typically used to determine an acute inhalation classification, this study included concentrations 4 times above the current recommended toxicity testing limit. The exposure concentrations were measured, and rats were treated for 6 hours per day. Since no mortality or significant clinical signs beyond narcosis were noted, this study is considered sufficient to support a STOT SE 3 classification. Pathology examinations and clinical chemistry measurements were also included in the study allowing a reliable prediction of no classification for acute toxicity by inhalation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: to observe the effects of the test substance - BTFB on male rats after repeated inhalation exposures over a 2 week period.
- Short description of test conditions: Male Crl:CD rats were exposed to BTFB at 0.10% or 1.03% in air with the control group exposed to air only for 6hrs/day, 5 days/week for 2 weeks. Clinical observations were made throughout the testing period with clinical chemical analyses performed following 10th exposure. Pathological examinations performed following necropsy with body and organ weigh analysis performed.
- Parameters analysed / observed:Clinical observations, pathological analysis, clinical chemistry, body weight
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-bromo-3,3,4,4-tetrafluorobut-1-ene
EC Number:
242-440-8
EC Name:
4-bromo-3,3,4,4-tetrafluorobut-1-ene
Cas Number:
18599-22-9
Molecular formula:
C4H3BrF4
IUPAC Name:
4-bromo-3,3,4,4-tetrafluorobut-1-ene
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Crl:CD
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Remarks:
via glass exposure chambers
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass exposure chambers
- Method of holding animals in test chamber: Not stated
- Source and rate of air: Not stated
- Method of conditioning air: Not stated
- System of generating particulates/aerosols: Not stated
- Temperature, humidity, pressure in air chamber: Temperature = less than or equal to 30˚C, Atmosphere = greater than or equal to 19%
- Air flow rate: Not stated
- Air change rate: Not stated
- Method of particle size determination: Not stated
- Treatment of exhaust air: Not stated

TEST ATMOSPHERE
- Brief description of analytical method used: Test item vapours were analysed on a HP 5700A GC with flame ionised detector and an injection splitter.
- Samples taken from breathing zone: yes

VEHICLE (if applicable)
- Justification for use and choice of vehicle: Not stated
- Composition of vehicle: Air
- Type and concentration of dispersant aid (if powder): N/A
- Concentration of test material in vehicle: 0.1% and 1%
- Lot/batch no. of vehicle (if requir
Analytical verification of test atmosphere concentrations:
yes
Remarks:
GC with flame ionisation detector
Duration of exposure:
6 h
Remarks on duration:
5 days a week for 2 weeks
Concentrations:
1% = 84650 mg/m3 = 84.65 mg/L
0.1% = 8465 mg/m3 = 8.465 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Remarks:
0% concentration
Details on study design:
- Dose selection rationale: Not stated
- Rationale for animal assignment (if not random): Not stated
- Fasting period before blood sampling for clinical biochemistry: Not stated
- Rationale for selecting satellite groups: Not stated
- Post-exposure recovery period in satellite groups: Not stated
- Section schedule rationale (if not random): N/A
- Other: N/A

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
84 650 mg/m³ air
Based on:
test mat.
Exp. duration:
6 h
Mortality:
none
Clinical signs:
other: decreased response to sound and loss of coordination.
Body weight:
The mean body weights of animals exposed to test material at 1.0% were significantly lower than those in the control group from exposure 5 through to the recovery period. Rats showed normal rate of weight gain during the recovery period.

Applicant's summary and conclusion