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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:
disregarded due to major methodological deficiencies
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was performed by a CRO known for falsifying data. Therefore, the quality of this study cannot be judged. However, since acute toxicity data on the inhalation route is not required according to Annex VIII of regulation (EC) 1907/2006, this IBT study is disregarded.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
The vapor was generated by passing a stream of clean, dry air (-40°C dewpoint) through a gas washing bottle containing the undiluted test material and into the test chamber.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: light brown powder

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: in stainless steel cages
- Diet: Wayne LAB-BLOX for Rats, Allied Mills, Inc., Chicago, Illinois, ad libitum (except during inhalation exposure)
- Water: ad libitum (except during inhalation exposure)
- Acclimation period: 5 days

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
GENERATION OF ATMOSPHERE
Vapor was generated by bubbling a stream of clean, dry air (-40°C dewpoint) through the undiluted test material. The resulting air-vapor mixt\ire was introduced into the exposure chamber at the top center, dispersed by a baffle plate and exhausted at the bottom of the chamber. The vapor generator was of all-glass construction and was linked to the exposure chamber by a short length of Tygon tubing. The air flow rate through the system was measured with a rotameter connected upstream of the generator. The rotameter was calibrated with a wet-test meter after the exposure was. completed. The average nominal vapor concentration was calculated by dividing the generator weight loss by the total volume of air used during the test.

EXPOSURE
Test animals were exposed in a specially constructed inhalation chamber. The chamber was designed so that the animals could be introduced into the test atmosphere after 99 percent of the maximum vapor concentration was established. Each animal was caged separately during exposure to minimize filtration of inspired air by animal fur.

TEST CHAMBER
Size: 80 l
atmospheric pressure: 29.92 (inches Hg)
temperature: 25 °C
air flow: 3.16 (l/min)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before exposure and at the end of observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6 300 mg/m³ air
Based on:
test mat.
Remarks on result:
other: Maximum attainable concentration at conditions stated.
Mortality:
No mortality occurred.
Clinical signs:
other: There were no untoward reactions during exposure or the 14-day observation period which followed.
Body weight:
The average 2-week body weight gains were within the normal limits.
Gross pathology:
Necropsy did not reveal any gross pathologic alterations.

Applicant's summary and conclusion