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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD 403 compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
231-494-8
EC Name:
Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7585-41-3
Molecular formula:
C18H13ClN2O6S.Ba
IUPAC Name:
barium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Details on test material:
- Substance type: red powder
- Physical state: solid
- Expiry date: > 5 years (1998)
- Lot/batch No.: 93/1068
- 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 (UK) Ltd., Manston, Kent (UK)
- Age at study initiation:
- Weight at study initiation: malles weighed 237 - 264g, and the females 200 - 207g
- Fasting period before study: not applicable
- Housing: groups of five by sex in
- Diet and water (e.g. ad libitum): With the exception of the exposure period, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.)
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23°C
- Humidity (%): 46 - 61%.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12 August 1993 To: 31 August 1993

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose-only apparatus
- Exposure chamber volume: 30 Litres
- Method of holding animals in test chamber: tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and
sealed by means of a rubber '0' ring
- Source and rate of air: Compressed air was supplied by means of a Gast oil free compressor and was passed through a water trap and respiratory quality filters which removed particulate material above 0.005 μm before it was introduced to the dust feed. Flow rate was 8 litres/min providing 36
air changes per hour.
- Method of conditioning air: Compressed air was supplied by means of a Gast oil free compressor and was passed through a water trap and respiratory quality filters which removed particulate material above 0.005 μm before it was introduced to the dust feed.
- System of generating aerosols: Wright Dust Feed' mechanism located at the top of the exposure chamber and driven by a variable speed motor. The dust feed was connected to a metered compressed air supply.
- Method of particle size determination: Cascade Impactor (10, 6, 3.5, 1.6, 0.9 and 0.5 μm cut-off points)
- Treatment of exhaust air: Extract from the exposure chamber passed through a 'scrubber' trap and was connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: negative pressure, humidity 41 - 50%, temperature 20 - 23°C


TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric method, employed glass fibre filters (Gelman type A/E 25 mm) placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone. Exposure chamber air was drawn through the filter at a measured rate using a vacuum pump for a suitable time period.
- Samples taken from breathing zone: yes


TEST ATMOSPHERE
- Particle size distribution: 83.1% < 4 μm; 100% < 10 μm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.4 μm / 0.34

The tested concentration was the highest attainable concentration.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4
Concentrations:
4.76 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:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.76 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: (range 3.24 - 6.34 mg/litre); 1/10 rats died.
Mortality:
One male was found dead approximately 186 minutes after the start of the exposure.
Clinical signs:
other: During exposure animals commonly showed wet fur, laboured, decreased or increased respiratory rate and red staining of the fur from the test material. On removal from the chamber and one hour after completion of exposure additional signs of toxicity noted
Body weight:
A marginal reduction in bodyweight gain was noted in several animals during the first week of the study. Expected bodyweight development was observed during week two.
Gross pathology:
The male that died during the study showed swollen and abnormally dark lungs and pink contents in the small intestine at necropsy. No abnormalities were detected in surviving animals at the end of the study.

Applicant's summary and conclusion