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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1979

Materials and methods

Principles of method if other than guideline:
One group of 15 male and 15 female rats was exposed six hours per day, five days per week, for thirteen weeks. eeks. The cumulative mean exposure concentration was 4.31 mg/m³. Animals were observed and mortality, body weight and clinical signs. Clinical and hematological parameters were determined. Necropsy examinations were performed on all survivors following the 13 week exposure.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplier: Monsanto Chemical Co., granular white dust

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Remarks on MMAD:
MMAD / GSD: avarage aerodynamic mass median diameter for the airborne dust was approximately 3.37 micrometers with an avarage geometric standard deviation of 2.51
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
six hours per day, 5 days per week for 13 weeks
Frequency of treatment:
five days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
4.31 mg/m³
Basis:

No. of animals per sex per dose:
one group of 15 male and 15 female rats
Control animals:
yes

Results and discussion

Effect levels

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

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

All animals survived the duration of the study. Increased incidences of dried red material around the nose of exposed animals was seen. Body weight was normal. No biologically significant differences in hematology, clinical chemistry and urinalysis was seen in exposed and control rats.

Body weight revealed no treatment related effects. Measurements of hematology, clinical chemistry and urinalysis did not show biologically significant differences between test material exposed and control rats.

analysis of organ weights, organ body weight ratios and organ brain weight ratios showed a few diffwerences between exposed and control values. The only one considered to represent a treatment related was the increase in lung weights in the exposed group.

Applicant's summary and conclusion

Executive summary:

One group of 15 male and 15 female rats was exposed six hours per day, five days per week, for thirteen weeks. eeks. The cumulative mean exposure concentration was 4.31 mg/m³. Animals were observed and mortality, body weight and clinical signs. Clinical and hematological parameters were determined. Necropsy examinations were performed on all survivors following the 13 week exposure.

All animals survived the duration of the study. Increased incidences of dried red material around the nose of exposed animals was seen. Body weight was normal. No biologically significant differences in hematology, clinical chemistry and urinalysis was seen in exposed and control rats.

Body weight revealed no treatment related effects. Measurements of hematology, clinical chemistry and urinalysis did not show biologically significant differences between test material exposed and control rats.

analysis of organ weights, organ body weight ratios and organ brain weight ratios showed a few diffwerences between exposed and control values. The only one considered to represent a treatment related was the increase in lung weights in the exposed group.

Treatment related lesions were seen grossly and microscopically in the lungs of the exposed group.