Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)

Endpoint summary

Description of key information

NOAEL (28 days, rat, dermal) ≥ 1000 mg/kg bw/day

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

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: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

The repeated dose toxicity of the test item was evaluated in a subacute, 28-day dermal study comparable to the OECD Guideline 410 (1981). 5 male and 5 female rats were administered 1000 mg test item/kg bw/day to the shaved, dorsal region for 6 hours/day for 28 days and monitored for mortality, skin irritation, clinical signs, body weight, food consumption, haematological abnormalities and clinical chemistry abnormalities. All animals were subjected to organ weighing and histological examination at termination. A negative control group was tested in parallel.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances are classified as specific target organ toxicants following repeated exposure, and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed. Substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure, are classified in Category 1 for target organ toxicity (repeat exposure). Classification in Category 1 is applicable when significant toxic effects are observed in a 90-day repeated-dose animal study at low concentrations (< 10 mg/kg bw/day in oral studies, and < 20 mg/kg bw/day in dermal studies) (CLP Regulation (EC 1272/2008): Annex 1, Part 3, Table 3.9.2).

Substances which can be presumed to have the potential to be harmful to human health following repeated exposure, based on evidence from animal studies, are classified in Category 2. Classification in Category 2 is applicable when significant toxic effects are observed in a 90-day repeated-dose animal study at generally moderate exposure concentrations (10 to 100 mg/kg bw/day in oral studies, and 20 to 200 mg/kg bw/day in dermal studies) (CLP Regulation (EC 1272/2008): Annex 1, Part 3, Table 3.9.3).

Equivalent guidance values for an equivalent 28-day study period raises the concentration values for classification by three-fold: classification in Category 1 is applicable at low concentrations (< 30 mg/kg bw/day in oral studies; < 60 mg/kg bw/day in dermal studies) and in Category 2 at generally moderate concentrations (30 to 300 mg/kg bw/day in oral studies, 60 to 600 mg/kg bw/day in dermal studies).

Based on the repeated dose subacute 28-day Dermal Toxicity Study on rats OECD 407 (1981), no classification of the substance is warranted for specific target organ toxicity: repeated exposure.