Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Provides basic data for initial dose selection in the 90 day study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: standard repeated dose
Principles of method if other than guideline:
Method: other
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Resorcinol
EC Number:
203-585-2
EC Name:
Resorcinol
Cas Number:
108-46-3
Molecular formula:
C6H6O2
IUPAC Name:
benzene-1,3-diol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
8 hrs/day
Doses / concentrations
Remarks:
Doses / Concentrations:
220 ppm
Basis:

Details on study design:
A preliminary 14 day inhalation exposure was conducted on 10 rats, five males and five females, to detemine the feasibility of the 220 ppm 
concentration for the 90 day study.  At the end of the exposure, all animals were sacrificed and examined grossly.

Results and discussion

Results of examinations

Details on results:
Except for slight hemorrhagic spotting on the lungs of one male rat, all tissues appeared essentially normal.  No tissues of animals in this group were examined histopathologically.  On the basis of this pilot study, it was concluded that the 220 ppm concentration was appropriate for the 90 day study

Effect levels

Dose descriptor:
other: Determination of definitive study concentration
Effect level:
220 ppm
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
A 14 day range finding study in 5 male and female Wistar rats (exposed to 220 ppm for 8 hrs/day) was conducted to determine appropriate concentrations for a subsequent 90 day study. At 220 ppm only one male rat had slight hemorrhagic spotting on the lungs while the remaining tissues appeared normal. No tissues of animals in this group were examined histopathologically. The subsequent 90 day study was considered invalid as it does not meet the requirements of current guidelines.