Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles For justification of read-across please refer to section 13.
Justification for type of information:
A read-across justification is provided in the IUCLID Chapter "Assessment reports"

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Blood and Brain n-Pentanol in Inhalation Exposure
Author:
Savolainen S, Pfaeffli and Elovaara
Year:
1985
Bibliographic source:
Acta pharmacol et toxicol 56: 260-264
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2009
Bibliographic source:
RIFM database

Materials and methods

Principles of method if other than guideline:
Analysis of tissue distribution of the test substance in rats after inhalation exposure (with body weight changes evaluation)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-pentanol
- Analytical purity: analytical grade

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 months
- Weight at study initiation: 254 ± 29 g for test group, 253 ± 22 g in control group

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Remarks on MMAD:
MMAD / GSD: not given
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic chamber (1 m3) technique with continous I.R. control
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
7 - 14 weeks
Frequency of treatment:
5 days per week, 6 hours daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100, 300, 600 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
0.36, 1.08, 2.16 mg/l
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes, sham-exposed
Details on study design:
Post-exposure period: none

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes

FOOD CONSUMPTION: no data

FOOD EFFICIENCY: no data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data
Sacrifice and pathology:
The tissue distribution of test substance was analysed at necropsy
Other examinations:
- alcohol and aldehyde concentrations in the brain were determined by gas chromatography
- calcium aggregated regated microsomes from liver and kidneys were analyzed for their cytochrome P-450 content
- Cytosolic n-pentanol dehydrogenase activities were also assayed in liver and kidney
Statistics:
The least squares method was used to find out the mathematical relationship of the inhaled and blood n-pentanol concentrations. All results were statistically evaluated with variance analysis.

Results and discussion

Results of examinations

Details on results:
BODY WEIGHT AND WEIGHT GAIN
The weight of the exposed animals did not differ from that of controls at the end of the experiment:
100 ppm: 435 ± 4 g
300 ppm: 397 ± 74 g
600 ppm: 400 ± 34 g
control: 419 ± 29 g

Effect levels

Dose descriptor:
NOAEL
Effect level:
2.16 mg/L air (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: only body weight data were considered (no changes observed); no additional data provided

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion