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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Information from migrated NONS file, as per inquiry number 06-2120053365-59- 0000, permission to refer granted by ECHA
Title:
Unnamed
Year:
2014

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:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
EC number 401-560-2
Notification number 87-04-0062-02
Result Partly provided (some studies submitted less than 12 years previously)

Test animals

Species:
rat
Strain:
other: rat, Wistar Bor:WISW (SPF-Cpb)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Substance was dissolved in demineralized water
Details on oral exposure:
Magensonde (gavage)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
In all animals of the treatment groups blueish discoloured faeces were found.
Mortality:
mortality observed, treatment-related
Description (incidence):
In all animals of the treatment groups blueish discoloured faeces were found.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
40 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

Any other information on results incl. tables

In the males of the high dose group reduced serum values for inorganic phosphorus, total protein and albumin were found. Increased cholesterol values were found in the females from the medium and high dose groups.

In the animals of the middle and high dose group a blue discolouring of the kidneys was found, additionally in the animals of the high dose group a blue discolouring of the connective tissue, the testes and the gastro-intestinal tract was seen. In the females of the high dose group the absolute and relative liver weight were increased. Microscopically no treatment related effects were found.

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified