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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with GLP standards according to Guideline OECD 407. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1987

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
Chemical structure
Reference substance name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
EC Number:
403-530-4
EC Name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
Cas Number:
129423-54-7
Molecular formula:
C17H13CaClN4O7S2
IUPAC Name:
calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Sesamol
Details on oral exposure:
28 days
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 62.5 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 62.5 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:No mortalities or symptoms of toxicity occurred during the test period.
Laboratory findings:
Haematologically, there were no changes to the measured values. A reduction in the inorganic phosphor values occurred among the females from the high-dose group. However, it was still within the range of physiological variation. The urine of the animals from the high-dose group had a reduced specific weight, something which was not, however, regarded as of toxicological significance.

Effects in organs:No substance-related changes

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:
1 000 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:
The repeated toxicity of the test substance was evaluated in a subacute 28-day oral toxicity study in rats. The study was conducted in accordance with the OECD guideline 407 and in compliance with GLP. The NOAEL was determined to be 1000 mg/kg bw/day.
Executive summary:

The test substance was orally administered daily in graduated doses (0, 62.5, 250, 1000 mg/kg bw/day) to male and female rats, one dose level per group for a period of 28 days. During the period of administration the animals were observed each day for signs of toxicity and for mortality. No mortalities or no symptoms of toxicity occurred during the test period. Based on the observations during the study the NOAEL was established to be 1000 mg/kg bw/day.