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Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: study suffers from deficiencies: only 1 dose used, solvent (aquous glycerol) was not the control, detailed data of the results were not presented, result description did not differ between phenol and m-cresol

Data source

Reference
Title:
No information
Author:
Aerogen Inc. (2001) Inhalation safety of phenol and m-Cresol in rodents: a fourteen day repeat dose toxicity study, study abstract as presented at ISAM Congress 2001
Year:
2001

Materials and methods

Principles of method if other than guideline:
Method: see freetext ME
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
m-cresol
EC Number:
203-577-9
EC Name:
m-cresol
Cas Number:
108-39-4
Molecular formula:
C7H8O
IUPAC Name:
m-cresol

Test animals

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

Administration / exposure

Route of administration:
inhalation
Remarks on MMAD:
MMAD / GSD: migrated dataset
Duration of treatment / exposure:
2 weeks (14 exposures)
Frequency of treatment:
6 hrs/d, 7 d
Doses / concentrations
Remarks:
Doses / Concentrations:
target conc.: 20 ug/l of an 0.25 % solution in 1.6 % aquous glycerol
Basis:

Control animals:
other: yes, water
Details on study design:
Post-exposure period: 2 weeks

Examinations

Observations and examinations performed and frequency:
see section "any other information on material and methods"
Sacrifice and pathology:
see section "any other information on material and methods"
Other examinations:
see section "any other information on material and methods"
Statistics:
see section "any other information on material and methods"

Results and discussion

Any other information on results incl. tables

Observed concentration: 27 ug/l, achieved pulmonary dose level: 690 ug/kg bw no animal died during the study, no treatment related clinical signs; incidental observations in all treatment groups including control groupswere salivation, diarrhea, wet inguinal fur, red material around nose and eyes, alopecia, lesions and red material around nose seen sporadically and in low frequencies during recovery period.
Body weights, body weight gain, hematology, blood chemistry were not statistically different from control group.
Terminal and recovery sacrifices:
No statistically differences in organ weights when compared to controls and no test-article related gross or histopathologic lesions. Observed minor inflammatory or degenerative changes observed in peribronchial, perivascular and subserosal regions were evaluated as incidental findings in rodent inhalation studies.

Applicant's summary and conclusion

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