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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-040-0
EC Name:
-
Cas Number:
272460-97-6
Molecular formula:
C30H26O4S2
IUPAC Name:
1-{4-[(4-benzoylphenyl)sulfanyl]phenyl}-2-methyl-2-(4-methylbenzenesulfonyl)propan-1-one
Test material form:
solid
Details on test material:
Nature of substance: ESACURE 1001

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of 0.5% methocel
Duration of treatment / exposure:
28 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
Dose / conc.:
800 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 100 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 800 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 800 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No toxicologically significant clinical signs were seen during the study and at the post-dose observations performed daily.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No statistically significant differences were observed in body weight or food consumption between control and treated groups throughout the study.
Haematological findings:
no effects observed
Description (incidence and severity):
No changes of toxicological significance were detected in haematological and coagulation parameters.
Urinalysis findings:
effects observed, non-treatment-related
Description (incidence and severity):
Urea levels were increased in both sexes from the low, mid and high dose groups when compared with controls. Although these changes achieved statistical significance at all dose-levels tested, they were considered without any toxicological significance because urea levels detected in all individual animals were within the expected range of historical data (mean, standard deviation: 41.1 mg/ml, 10.3 for males and 47.4 mg/ml, 10.3 for females). No toxicological significance was attributed to all other statistically significant changes observed as they were not corralted with the dose-level and were not consistent between sexes
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Terminal body weight, absolute and relative organ weights were unaffected by treatment and no macroscopic change was seen in the sacrificed animals that could considered to be treatment-related
Neuropathological findings:
no effects observed
Description (incidence and severity):
Neurotoxicity tests and measurements performed at the end of treatment did not show changes attribuitable to treatment

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
800 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
800 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:
Not classified