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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006

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:
C24H30O6
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 animals

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

Administration / exposure

Route of administration:
oral: feed
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days treatment and 28 days reversibility period.
Frequency of treatment:
7d/week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
Males 123.1, 406.4 and 1261.3 mg/kg bw/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
Females 135.7, 478.5 and 1479.2 mg/kg bw/day
Basis:
nominal in diet
No. of animals per sex per dose:
Treatment groups: 20 males/20 females
Control group: 30 males/30 females
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

BODY WEIGHT: Yes :

FOOD CONSUMPTION: No data ; AND COMPOUND INTAKE (if feeding study): Yes

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: Yes .

Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
CLINICAL SIGNS AND MORTALITY
There were no deaths and no clinical signs.

BODY WEIGHT AND WEIGHT GAIN
A decreased bodyweight gain was noted in males receiving 406.4 mg/kg bw/day (not statistically significant) and males and females receiving 1261.3 or 1479.2 mg/kg bw/day (statistically significant).

CLINICAL CHEMISTRY

A very slight increase in blood urea nitrogen was noted in rats receiving1261.3 or 1479.2 mg/kg bw/day (not statistically significant) This effect was reversible after 4 weeks without treatment.

HISTOPATHOLOGY: NON-NEOPLASTIC

No histopathological findings were considered to be treatment related.


Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
406.4 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Decreased bodyweight gain in males and females receiving 1261.3 or 1479.2 mg/kg bw/day.
Dose descriptor:
NOEL
Effect level:
123.1 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test substance is of low subchronic oral toxicity to rats