Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex VI
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
423-630-1
EC Name:
-
Cas Number:
62435-71-6
Molecular formula:
C7H14O2
IUPAC Name:
2-(ethoxymethyl)oxolane

Test animals

Species:
other: Rat (Sprague-Dawley)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Distilled water
Details on oral exposure:
Method of administration:
Gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality data:

There were no deaths during the study.


Clinical observations:

No clinically observable signs of toxicity were detected in
test or control aniamls throughout the study period.

Increased salivation was detected prior to and/or
approximately two minutes after dosing in 1000 or 500
mg/kg/day animals from Days 4 or 5 respectively together
with incidents of fur wetting. This was considered to be a
consequence of an unpalatable or slightly irritant test
material formulation and was considered not to be indicative
of toxicity.


Functional observations:

There were no adverse treatment-related behavioural,
functional performance or sensory reactivity effects
observed.


Bodyweight:

No adverse effect on bodyweight development was detected.


Food consumption:

No adverse effect on dietry intake was detected.


Water consumption:

No intergroup differences were detected.

Laboratory findings:
Haematology:

No treatment-related effects were detected.


Blood chemistry:

In females, small but dose-related decreases in urea, total
protein and albumin were observed all of which were
statistically significant at 500 mg/kg/day and above.


No such changes were detected at the other dose levels.

Effects in organs:
Necroscopy:

No macroscopic abnormalities were detected at terminal kill.


Organ weights:

Animals of either sex treated with 1000 mg/kg/day showed an
increased liver weight, relative to bodyweight (18% in
males, 12% in females) and also absolute weight (24% in
males, 14% in females) when compared with controls. There
were no other changes considered toxicologically
significant.


Histopathology:

Microscopic examination of liver secretions revealed changes
identified as centrilobar hepatocyte enlargement for animals

of either sex treated with 1000 mg/kg/day and for one male
treated with 500 mg/kg/day.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified