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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: 1 low dose level only; limited set of investigations (respiratory tract only)

Data source

Reference
Title:
No information
Author:
Marshall HE, Keenan KP, McDowell EM (1987). The stathmokinetic and morphological response of hamster respiratory epithelium to intralaryngeal instillations of saline and ferric oxide. Fundam Appl Toxicol 9, 705-714.

Materials and methods

Principles of method if other than guideline:
weekly repeated intralaryngeal instillation 15 to 20 animals per group
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Diiron trioxide
EC Number:
215-168-2
EC Name:
Diiron trioxide
Cas Number:
1309-37-1
Molecular formula:
Fe2O3
IUPAC Name:
Diiron trioxide
Details on test material:
IUCLID4 Test substance: other TS: Fe2O3 (Pfizer Chemical, type R3098R, Lot J5)

TS-Freetext:
Fe2O3; purchased from Pfizer Chemical; no further data

Test animals

Species:
hamster, Syrian
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
other: intralaryngeal
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
1, 5, 10, or 15 weeks
Frequency of treatment:
once a week
Doses / concentrations
Remarks:
Doses / Concentrations:
3 mg/animal/dose
No. of animals per sex per dose:
no data
Control animals:
yes
Details on study design:
Post-exposure period: no

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
No difference of mitotic rate on the tracheal and bronchial
epithelium but in the bronchioles; bronchioalveolar hyper-
plasia after 5 applications and less prominent after 10 or
15 treatments

Applicant's summary and conclusion

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