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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
A read-across justification is provided in the IUCLID chapter "assessment reports"

Data source

Reference
Reference Type:
publication
Title:
Effects of several alcohols on glucosidase activities in rat liver and brain
Author:
San-Juan I et al.
Year:
1992
Bibliographic source:
Comp. Biochem. Physiol. Vol. 101B, No. 1/2, pp. 41-47

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Analysis of glycosidases from liver and brain of alcohol-treated rats and their kinetics
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
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): amyl alcohol
- Source: Mallinckrodt

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: 35 days
- Weight at study initiation: mean 75 g
- Diet (e.g. ad libitum): A-04 rat chow from Panlab (Barcelona, Spain), containing 17% protein, 3% lipids and 59% carbohydrates; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
50 day
Frequency of treatment:
continuously, ad libitum
Doses / concentrations
Remarks:
Doses / Concentrations:
1 -4% for 8 days , followed by an additional period of 40-50 days using a 4% aqueous alcohol solution
Basis:
nominal in water
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent vehicle
Details on study design:
The alcohols were given progressively at 1-4% for 8 days (adaptation period), followed by an additional period of 40-50 days using a 4% aqueous alcohol solution. During the same period of time, control rats, belonging to the same litter as the alcohol-treated rats, drank only water.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The only effects on glycosidases seen after treatment with amyl alcohol was an significant increase in the activity of beta-D-glucuronidase from brain (0.09 +/-0.02 mU/mg protein; control 0.08 +/-0.01 mU/mg protein).

Applicant's summary and conclusion