Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Some details are provided on the generation of the test atmosphere. A NOAEC was not derived and the results provided as a very concise summary.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1970

Materials and methods

Principles of method if other than guideline:
The inhalation toxicity of 109 substances has been studied by exposing experimental animals to known concentrations in air for periods of about three weeks.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Triboron trimethyl hexaoxide
EC Number:
203-016-8
EC Name:
Triboron trimethyl hexaoxide
Cas Number:
102-24-9
Molecular formula:
C3H9B3O6
IUPAC Name:
trimethoxy-1,3,5,2,4,6-trioxatriborinane
Details on test material:
- Name of test material (as cited in study report): Trimethoxyboroxine
- Physical state: liquid

Test animals

Species:
rat
Strain:
other: Alderley Park specific-pathogen-free
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ± 200 g
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
The air used for the atmospheres was filtered, dried to a relative humidity of less than 10%, and supplied at a line pressure of 1 atm (1.013 E05 Nm-2).A nearly saturated vapour obtained by passing air through a liquid contained in a bubbler with a sintered glass air-distributor disc. The volume of the liquid was usually 10-20 mL and, if the size of the sample available permitted, it was replaced daily. The bubbler was maintained in a water-bath at room temperature (±20°C)

CHAMBER DESCRIPTION
In all of these experiments the animals have been exposed to dynamic atmospheres, that is, to atmospheres continuously generated and passed through the exposure chamber. A glass desiccator, containing wire mesh partitions to separate the animals, was used.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The nearly saturated concentration prepared was estimated by weighing the sample before and after the day's run, and relating the weight loss to the volume of air passing. This concentration, expressed in milligrams per litre, was converted to parts per million on the assumption that the sample was pure.
Duration of treatment / exposure:
6 hours/day
Frequency of treatment:
9 exposures
Doses / concentrations
Remarks:
Doses / Concentrations:
3 mg/L
Basis:
analytical conc.
No. of animals per sex per dose:
3 males and 4 females
Control animals:
yes, sham-exposed

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Each morning

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No data

HAEMATOLOGY: Yes / No / No data
- Time schedule for collection of blood:One day after last exposure
- Anaesthetic used for blood collection: Yes (halothane)
- Animals fasted: No
- How many animals: All

CLINICAL CHEMISTRY: No data

URINALYSIS: Yes
- Time schedule for collection of urine: Overnight after the last exposure
- Metabolism cages used for collection of urine: No data
- Animals fasted: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
Slight lethargy was observed

GROSS PATHOLOGY
Organs were normal

Effect levels

Dose descriptor:
NOAEC
Remarks on result:
not determinable
Remarks:
no NOAEC identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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