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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
Annex V B.7, OECD n.407
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Version / remarks:
Annex V B.7, OECD n.407
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
472-110-0
EC Name:
-
Cas Number:
71868-15-0
Molecular formula:
C20H22O5
IUPAC Name:
2-hydroxy-1-{4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]phenyl}-2-methylpropan-1-one
Test material form:
solid
Details on test material:
- Appearance: white powder

Test animals

Species:
rat
Strain:
other: Hsd

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Water ad inj.
Details on oral exposure:
Method of administration:
Gavage of a suspension, using a stomach tube
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
No severe treatment-related clinical signs were observed.
Mortality:
no mortality observed
Description (incidence):
No animals died during the study.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Bodyweight were affected by treatment in male high dose group
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Food consumption were affected by treatment in male high dose group
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
Some individual haematology deviations were observed but considered not biologically relevant.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No differences between dosed group and control are observed in urine parameters.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Histopathological findings considered to be direcly treatment-related were observed in the adrenal gland, liver, lung and spleen, in 50 and 150 mg/kg bw dose groups.
After 14 days recover period for High dose group, liver changes were fully reversible and adrenal gland, lung and spleen chenges had almost reversed.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
5 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
histopathology: non-neoplastic

Target system / organ toxicity

Key result
Critical effects observed:
no
Lowest effective dose / conc.:
50 mg/kg bw/day (actual dose received)

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day.
Executive summary:

A study was conducted to determine the repeated dose oral toxicity of the test substance according to OECD Guideline 407 and EU Method B.7, in compliance with GLP. Groups of 5 male and female Hsd rats were administered 0, 5, 50 and 150 mg/kg bw/day of test substance by oral gavage for 28 days. There were no treatment-related changes at 5 mg/kg bw/day. No severe treatment-related clinical signs were notede at any dose. Individual haematology deviations were observed but considered not biologically relevant. No significant changes were observed in urine parameters. In the high dose group, feed consumption and body weight were affected in males. Treatment-related histopathological findings were observed in the adrenal gland, liver, lung and spleen, at 50 and 150 mg/kg bw. After 14 days recovery period for the high dose group, liver changes were fully reversible and adrenal gland, lung and spleen changes had almost reversed. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day (Bioservice, 2007).