Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Endpoint summary

Description of key information

28- day repeated oral toxicity (OECD 407): NOAEL (rat, male / female) 1000 mg/kg bw/day. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes

Limit test:

no

Species:

rat

Strain:

Wistar

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

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

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

Critical effects observed:

not specified

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

exposure considerations

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

exposure considerations

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated toxicity of the test substance was evaluated in a guideline compliant study in accordance with GLP. The male and female rats were exposed to test substance in graduated doses for 28 days. 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.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The guideline compliant study.

Justification for classification or non-classification

Based on the available data there is currently no need for classification of this substance for repeated toxicity according to the CLP Regulation (EC) 1272/2008 and EU Directive 67/548/EEC.