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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butylbenzenesulphonamide
EC Number:
222-823-6
EC Name:
N-butylbenzenesulphonamide
Cas Number:
3622-84-2
Molecular formula:
C10H15NO2S
IUPAC Name:
N-butylbenzenesulfonamide
Details on test material:
- Name of test material (as cited in study report): Dellatol BBS
- Substance type: mono constituent substance - organic
- Physical state: clear liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): 0.1% Diphenylsulphon/0.1% water/0.1% Butylbenzeensulphate/0.02% Butylamine
- Composition of test material, percentage of components: 99.8% Dellatol BBS
- Isomers composition:
- Purity test date: 20-11-1989
- Lot/batch No.: 174-180
- Expiration date of the lot/batch:
- Stability under test conditions: stable
- Storage condition of test material: roomtemperature and dark room
- Other:

Berechnung der Dampf-sättigungskonzentration

°c Dampfdruck (kPa) Sättigungskonz. (mg/m³ Luft)

15 0,38614 E-06 0,34332 E-01
17 0,48044 E-06 0,42422 E-01
19 0,59598 E-06 0,52264 E-01
21 0,73715 E-06 0,64203 E-01
23 0,90913 E-06 0,78648 E-01
25 0,11181 E-05 0,96077 E-01
27 0,13713 E-05 0,11705
29 0,16773 E-05 0,14222
31 0,20462 E-05 0,17236
33 0,24897 E-05 0,20835
35 0,30217 E-05 0,25122
37 0,36581 E-05 0,30218
39 0,44178 E-05 0,36259
41 0,53225 E-05 0,43406
43 0,63973 E-05 0,51842
45 0,76714 E-05 0,61776
47 0,91784 E-05 0,73449
49 0,10957 E-04 0,87138

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Kres Paderborn
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 180 - 210g
- Fasting period before study:
- Housing:Makrolon-cages type III, 5 animals by cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2°c
- Humidity (%): +- 50%
- Air changes (per hr): +- 10 changes per hour
- Photoperiod 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 23-11-1990 To: 07-12-1990

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: breathing room from the firma Rhema Labortechnik
- Exposure chamber volume: Ø: 30cm, h: 28cm, (volume: +- 20l)
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air: aerosolfilter
- Temperature, humidity, pressure in air chamber: with rats: temperature: 25°c, humidity: 34%
without rats: temperatures: 24°c, humidity: 14%


TEST ATMOSPHERE
- Brief description of analytical method used: GC FID
- Samples taken from breathing zone: yes


VEHICLE
- Composition of vehicle (if applicable):/
- Concentration of test material in vehicle (if applicable):/
- Justification of choice of vehicle: /
- Lot/batch no. (if required): /
- Purity: /


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: With an aerodynamic particle sizer with laser-velocimeter (TSI-APS 3300)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
BBSA 99.8% - concentration at saturation (in air) : 0.06 µg/l at 20°c
No. of animals per sex per dose:
air controle: 5 males/5 females
3431 mg/m³: 5 males/5 females
3439 mg/m³: 5 males/5 females
4066 mg/m³: 5 males/5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other:

Results and discussion

Preliminary study:
standard acute method
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 066 mg/m³ air
Exp. duration:
4 h
Mortality:
no mortality
Clinical signs:
other:
Body weight:
no changes in body weight
Gross pathology:
no changes
Other findings:
- Organ weights: /
- Histopathology: /
- Potential target organs: /
- Other observations:/

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50-inhalation (aerosol) is > 4066 mg/m³ (4h). The NOEL is 3431 mg/m³. At the lowest applied dose (3431 mg/m³) the rats tolerated the test substance without symptoms. At higher doses (3439 mg/m³and
4066 mg/m³) piloerection was observed. After one day no clinical symptoms were observed.
Executive summary:

An acute inhalation study in male and female Wistar rats was conducted according to nose/head only procedure at concentrations of 3431 and 3439 mg/m³.The LC50-inhalation (aerosol) is > 4066 mg/m³ (4h) and the NOEC is 3431 mg/m³. At the lowest applied dose (3431 mg/m³) the rats tolerated the test substance without symptoms. At higher doses (3439 mg/m³and

4066 mg/m³) piloerection was observed. After one day no clinical symptoms were observed.

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