Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-752-1 | CAS number: 71-41-0
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Blood and Brain n-Pentanol in Inhalation Exposure
- Author:
- Savolainen S, Pfaeffli and Elovaara
- Year:
- 1 985
- Bibliographic source:
- Acta pharmacol et toxicol 56: 260-264
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- RIFM
- Year:
- 2 009
- 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 substance name:
- Pentan-1-ol
- EC Number:
- 200-752-1
- EC Name:
- Pentan-1-ol
- Cas Number:
- 71-41-0
- Molecular formula:
- C5H12O
- IUPAC Name:
- pentan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): n-pentanol
- Analytical purity: analytical grade
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
