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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Colourless liquid
received 20 November 1989
stored in dark at ambient temperature
Acid value 0.01 mg KOH/g
water contnet = 0.04%
colour H.U.= 10
Det. Index at 25C: 1.463

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles RiverUk Ltd, Margate
- Age at study initiation: not given
- Weight at study initiation: 111-139g
- Fasting period before study: none
- Housing:1-2 rats per cage, polypropylene with steel mesh lids and bottoms
- Diet (e.g. ad libitum): Rat and Mouse (modified) No1 Diet SQC expanded ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:at least 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-23C
- Humidity (%): 36-68%
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12hr light dark cycle


IN-LIFE DATES: From:20 Feb 1990 To:10 MArch 1990

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:cylindrical aluminium exposure chamber
- Exposure chamber volume: 41.5 litres
- Method of holding animals in test chamber: polycarbonte restraint tubes
- Source and rate of air: hydrovane compressors 8 litres/min
- Method of conditioning air:
- System of generating particulates/aerosols:sage syringe pump continuous metering of substance through a glass concentric jet atomiser.
- Method of particle size determination: Marple cascade impactor in breathing zone of animals 2l/min sampling rate
- Treatment of exhaust air:high efficiency filter to a metered vaccum system
- Temperature, humidity, pressure in air chamber: 18-19C, RH for three groups 38-72%, 38-80%, 71-90%


TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric method sorbent(silica) gel sampling tubes
- 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: 42% <3.5µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 4.6µm/ GSD 3.3µm


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Remarks:
measured gravimetric concentration
Duration of exposure:
4 h
Concentrations:
3.8 mg/L dose rangefinding
7.19 mg/L main study
No. of animals per sex per dose:
2 groups of 2 male and 2 female Sprague-Dawley rats were exposed to a measured gravimetric concentration of TCPP of up to 3.80 mg/L by snout only inhalation, in a dose range finding study, for a period of 4 hours. A further group of 5 female and 5 male Sprague-Dawley rats were exposed to a concentration of TCPP of 7.19 mg/L, also for 4 hours. This was based on the results obtained with the concentration used in the range-finding study.
Control animals:
not specified
Details on study design:
All animals were observed continuously for clinical signs throughout the exposure period, for the first 1-2 hours post-dosing and thereafter once daily during the subsequent 3 day (dose range finding study) or 14 day (main study) observation period. All rats were weighed immediately before dosing and on days 1 and 3 post exposure for the dose ranging finding study and on days 2, 3, 4, 7, 10 and 14 post exposure for the main study. At the end of the study, all animals were subjected to a macroscopic post mortem exam.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7 mg/L air
Exp. duration:
4 h
Mortality:
There were no deaths during the study.
Clinical signs:
No unusual clinical observations were recorded during the exposure period. All animals appeared slightly unkempt and had red staining around the snout and eyes immediately after dosing. No abnormalities were observed during the subsequent 14-day observation period.
Body weight:
There was no effect on body weight.
Gross pathology:
No abnormalities were observed at post mortem.
Other findings:
lung/bodyweight ratios observed were considered to be within normal limits.

Any other information on results incl. tables

The acute inhalation LC50 is taken to be greater than 7 mg/L from this study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation LC50 is taken to be greater than 7 mg/L from this study.
Executive summary:

2 groups of 2 male and 2 female Sprague-Dawley rats were exposed to a measured gravimetric concentration of TCPP of up to 3.80 mg/L by snout only inhalation, in a dose range finding study, for a period of 4 hours. A further group of 5 female and 5 male Sprague-Dawley rats were exposed to a concentration of TCPP of 7.19 mg/L, also for 4 hours. This was based on the results obtained with the concentration used in the range-finding study. The acute inhalation LC50 is taken to be greater than 7 mg/L from this study.