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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:
other information
Study period:
11/11/1983 - 01/20/1984
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant metholdological deficiences.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 10 male and 10 female rats were exposed to dust atmospheres of VazoR 64 for single 1-hour periods. The purpose of this study was to determine the 1-hour LC50 for VazoR 64 in male and female rats.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Purity > 98%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding laboratories, Kingston, NY
- Age at study initiation: 8-9 week old
- Weight at study initiation: 240-265 g (males), 161-181g (females)
- Fasting period before study: no data
- Housing: in pairs (sexes separate) in 8''x8''x14'' stainless steel, wire-mesh cages.
- Diet (e.g. ad libitum): Purina certified rodent chow #5002, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:n 1 week

ENVIRONMENTAL CONDITIONS
- Temperature : 74+/-2°F
- Humidity (%): 50+/-10
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: no data
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
1 h
Concentrations:
1.57 , 3.40, 7.78 mg/L
No. of animals per sex per dose:
10 animals/ sexe/dose
Control animals:
no
Details on study design:
All rats were weighed and observed daily for 2 weeks post exposure, except for the saturday a,d sunday of the second week post exposure.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7.78 mg/L air
Exp. duration:
1 h
Mortality:
One male rat died one day after exposure to 1.57 mg/l of Vazo 64. No death occurred after exposure followed by a return to a normal weight gain rate.
Clinical signs:
other: About half of the rats showed wet or stained perineal areas for one to two days after exposure.
Body weight:
Most rats showed moderate to severe weight losses one or two days after exposure followed by a return to a normal weight gain rate.

Applicant's summary and conclusion

Conclusions:
LC50 was not determined with this study. During exposures, only 10% at most of the airborne dust was of respirable size (<10 µm aerodynamic diameter).