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

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: review

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Search from various sources.

Test material

Test material information

Constituent 1

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

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results

Executive summary:

TOXICOKINETICS EVALUATION No toxicokinetic study is performed for the substance. The evaluation is based on the available information from other toxicological studies. No systemic toxic effects were described after single oral application of the dose level 2000 mg/kg of the substance to rats. Observed coloured faeces faded away till 3 days after application of the test substance. No systemic toxic effects were recorded after single dermal application of the dose level 2000 mg/kg of the substance to rats. After single application on skin of rabbit, no irritant or corrosive effects were observed. No symptoms of systemic toxicity were observed in rats after application on skin. Examination of eye after single application of substance to the conjunctival sac demonstrated that the substance is not irritating for eye of rabbit; the changes observed were reversible (injected blood vessels up to diffusely crimson-coloured redness, swelling with the eyelids turned outwards, reddened iris, yellow discharge - these changes disappeared in two day after test substance application). No corrosive effects were observed on eyes of rabbit and no clinical signs of systemic intoxication were detected. In the sensitization test the substance elicited no response after topical application to the skin of the guinea pigs. No clinical signs of systemic toxicity were detected in this study. In the subacute oral toxicity study the substance was administered to rats for a period of 28 days at dose levels 62.5, 250 and 1000 mg/kg/day. No systemic toxicity was observed during the study. Only decreased specific weight of urine was recorded at the highest dose level. In the reproduction/developmental toxicity screening test the experimental animals were exposed to test item at 160, 400 and 1000 mg/kg/day were administered. Pathological examination revealed the test substance-colouring of caecum and stomach contents without changes of structure of organs. The following adverse effects caused by the test substance treatment at the highest dose level (limit dose) were decreased relative and absolute weight of prostate gland and occurrence of atrophic changes in prostate gland of parental males. These changes have no influence on fertility of parental males. Number of females achieving pregnancy, durations of mating and pregnancy, number of pups, sex ratio, average weight of litter, average body weight and postnatal development of pups were unaffected by the test substance treatment.