Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 October 1978 - 14 November 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study is performed pre-GLP and method is comparable to OECD 403. Method is well described but reporting of results is done with little detail. No necropsy was performed. Bodyweight of the animals are not recorded. Responses of individual animals are not shown. Since test substance preparation and animal exposure are described in detail the study is considered valid with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
The study was performed according to an in-house method from TNO (Zeist, The Netherlands) this method was comparable to OECD403.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Chloramine-T
Appearnce: white powder.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist , The Netherlands.
- Age at study initiation: no data
- Weight at study initiation: males 182g and females 140g
- Fasting period before study: none, during the study period the animals did not have access to food.
- Housing: The animals were exposed in a stainless steel exposure chamber with a capacity of 1.5 m3. In the exposure chamber the animals were individually housed in wire-screen cages. They could continuously be observed through the hard glass entrance door of the chamber. During the 14-day observation period the animals were housed in stainless steel cages which were suspended in an open rack.
- Diet (e.g. ad libitum): ad libitum, institute's stock diet for rats.
- Water (e.g. ad libitum): ad libitum, bottled unfluorinated water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 40-50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: 31 October 1978 To: 14 November 1978

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel exposure chamber
- Exposure chamber volume: 1.5 m3
- Method of holding animals in test chamber: wire-screen cages.
- Source and rate of air: air flow rate of 0.84 m3/h.
- Method of conditioning air: no data
- System of generating particulates/aerosols: "Wright" Dust Feed Mechanism
- Method of particle size determination: Particle size determinations and counts were carried out in samples taken from the atmosphere in the chamber with a Cascade impactor.
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the dispersed Chloramine T was determined gravimetrically by passing a measured amount of the test atmosphere through a glassfibre filter.
- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Particle size determinations in impaction samples revealed a maximum particle diameter of 6.7 µm. Eighty percent of the dispersion consisted of particles with a diameter of 0.8-4.7 µm.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
continuously at a max. conc. of 275 mg/m3 air
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 275 mg/m³ air
Exp. duration:
4 h
Mortality:
no mortality
Clinical signs:
other: During the first 30 minutes of the exposure period the rats were slightly restless. The restlessness gradually disappeared and after one hour all rats were quiet.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
It was concluded that the 4-hour LC50 of Chloramine T was higher than 275 mg/m3 air. This was the maximum attainable concentration in air. Therefore Chloramine T is not classified for acute inhalation toxicity.
Executive summary:

The acute inhalation toxicity of Chloramine T was studied by exposing rats for 4-hours to a dust dispersion of the substance in air at a concentration of 275 mg/m3 air. This was the maximum attainable concentration in air. No mortality occurred and no signs of intoxication were observed. It was concluded that the 4-hour LC50 of Chloramine T was higher than 275 mg/m3 air.