Diutan gum

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Report of an acute inhalation toxicity study using standard method, in accordance with EPA guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA 40 CFR 163.81-3

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

439-070-6

EC Name:

-

Cas Number:

125005-87-0

Molecular formula:

Not applicable

IUPAC Name:

(2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

215-300g weight at study start, housed in groups by sex (except during exposure) at 70 +/-2 degrees F and 30-60% RH.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Rats restrained individually within a 392L dynamic airflow exposure chamber. Spengler dust generator used to create test atmosphere (nominal concentration 4.9 mg/l based on sample weight consumed and air volume passing through exposure chamber). Achieved atmospheric concentration and particle size distribution measured.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetric measurement: atmospheric samples taken near animals breathing zone (6 minutes collection into vacuum sampler) 30,90,150 and 210 minutes after start of exposure.

Duration of exposure:

4 h

Concentrations:

The test atmosphere (nominally 4.9 mg/l ) was determined by measurement to 0.316 mg/l (mean across sampling times).
Particle size distribution (measured using Andersen plate sampler during the final 15 minutes of exposure): 100% <10 microns, 28.9% =/<1.1 microns.

No. of animals per sex per dose:

5 males, 5 females.

Control animals:

yes

Details on study design:

After 14 days post-exposure observation, all rats were terminated: following gross pathology observations at necropsy, lungs and tracheal structures were collected into buffered formalin. Lungs and tracheal samples were also collected from a sample of rats taken at the time of animal delivery (pre-study) and from a supplementary non-exposed control group (additional to the air-exposed controls) at study termination.

Statistics:

Not applicable.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: NOAEC

Effect level:

0.316 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Equal to a nominal exposure level of 4.9 mg/L

Mortality:

None

Clinical signs:

other: No significant treatment-related effects (intermittent nose-rubbing during exposure).

Body weight:

No effect on weight gain (test animals compared to exposed controls).

Gross pathology:

3 test animals showed mottled lungs (one with areas of consolidation) and one showed a mottled kidney. Two unexposed controls showed mottled lungs.

Other findings:

Histopathology: indications of intercurrent infection (tracheitis, focal pneumonitis or peribronchitis) were seen in some rats, but the incidence and severity of this did not differ across test, exposed control and unexposed control groups.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No evidence of toxicity was seen after 4-hour exposure of rats to a test substance dust atmosphere nominally 4.9 mg/l and measured at 0.316 mg/l. The difference between nominal and measured concentrations may indicate that close to a maximum practicable concentration was achieved.