Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

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: other: see freetext ME
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: m-cresol, not specified further

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
migrated dataset

Administration / exposure

Route of administration:
inhalation
Vehicle:
other: migrated dataset
Remarks on MMAD:
MMAD / GSD: migrated dataset
Details on inhalation exposure:
migrated dataset
Details on analytical verification of doses or concentrations:
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:

No. of animals per sex per dose:
migrated dataset
Control animals:
other: yes, water
Details on study design:
Post-exposure period: 2 weeks

Examinations

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

Results and discussion

Effect levels

Dose descriptor:
other: migrated dataset
Effect level:
other: migrated dataset
Basis for effect level:
other: migrated dataset: see section " remarks on results"

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:

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

Executive summary:

migrated dataset