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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Red 0106-PP1
IUPAC Name:
Red 0106-PP1

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF-bred Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG300
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
10 Males and 10 females
Dose / conc.:
50 mg/kg bw/day (nominal)
Remarks:
5 Males and 5 females
Dose / conc.:
200 mg/kg bw/day (nominal)
Remarks:
5 Males and 5 females
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Remarks:
10 Males and 10 females

Results and discussion

Results of examinations

Description (incidence and severity):
No test item-related clinical signs of toxicological relevance were noted during daily cageside observations or detailed weekly observations
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
effects observed, non-treatment-related
Description (incidence and severity):
Grip strength
No test item-related changes in the mean fore- or hindlimb grip strength were noted in males or females at any dose level.
Locomotor activity
No test item-related differences in mean locomotor activity were noted at any dose level.
Description (incidence and severity):
Elevated absolute and relative liver weights were noted after four weeks' treatment in females treated with 1000 mg/kg/day. These differences were largely reversible after two weeks' recovery.
No further test item-related changes in absolute or relative organ weights were noted at any dose level when compared with the controls.
Description (incidence and severity):
At necropsy, red-brown discoloration of the mucosa of the stomach and/or small and large intestine was recorded in some males and females after 4 weeks' treatment with 1000 mg/kg/day. These findings were considered to be test item-related and were no longer evident in the animals necropsied afler 2 weeks' recovery.
Description (incidence and severity):
No test item-related microscopic findings were noted in this study. No microscopic findings which corresponded to the aforementioned macroscopic findings were noted. All findings noted in this study were considered to be spontaneous findings commonly observed in rats of this strain and age.

Effect levels

Dose descriptor:
NOAEL
Effect level:
200 mg/kg bw/day (nominal)
Basis for effect level:
gross pathology
organ weights and organ / body weight ratios
urinalysis

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL = 200 mg/kg bw/day
NOEL = 200 mg/kg bw/day