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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
repeated dose toxicity: oral
Remarks:
other: no data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. That´s why the reliability is estimated to be at level 2.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 408 (1981) EEC Directive 87/302 (1987) - Annex V Part B
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-110-2
EC Name:
-
Cas Number:
135861-56-2
Molecular formula:
C24 H30 O6
IUPAC Name:
(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
other: Sprague-Dawley rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: /
Details on oral exposure:
Method of administration:
dietary admixture.
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 30 animals at 0 mg/kg bw/day
Male: 20 animals at 123.1 mg/kg bw/day
Male: 20 animals at 406.4 mg/kg bw/day
Male: 20 animals at 1261.3 mg/kg bw/day
Female: 30 animals at 0 mg/kg bw/day
Female: 20 animals at 135.7 mg/kg bw/day
Female: 20 animals at 478.5 mg/kg bw/day
Female: 20 animals at 1479.2 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No mortality and no treatment-related clinical signs were
noted.
A decreased body weight gain was noted for group 3
males
(not significant) and group 4 males and females
(statistically significant).
Laboratory findings:
A very slight increase of blood urea nitrogen was noted in
group 4 (not significant when compared to controls). This
effect was reversible after 4 weeks without treatment.
Effects in organs:
No histopathological finding was considered to be
treatment related.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
406.4 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
123.1 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