Diiodohydroxyquinoline

Endpoint summary

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Data is from RTECS ,SAX handbook and ACToR database.

GLP compliance:

not specified

Species:

other: Human

Strain:

other: not applicable

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

2 years

Frequency of treatment:

intermittent frequency

Dose descriptor:

other: TDLo

Effect level:

120 000 other: mg/kg

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Sense Organs and Special Senses (Eye) - visual field changes

Critical effects observed:

not specified

Conclusions:

Repeated dose oral toxicity value of diiodohydroxyquinoline to Human - child was found to be TDLo(Lowest published toxic dose): 120000 mg/kg, when diiodohydroxyquinoline was administered orally for 2 years.

Executive summary:

Repeated dose oral toxicity value of diiodohydroxyquinoline to Human - child was found to be TDLo(Lowest published toxic dose): 120000 mg/kg, when diiodohydroxyquinoline was administered orally for 2 years.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

chronic

Species:

other: human

Quality of whole database:

Data is from a long term study (2 years) wherein the TDLo was found to be greater than 120000 mg/kg body weight in humans

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 adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

Data is from a long term study (2 years) wherein the TDLo was found to be greater than 120000 mg/kg body weight in humans

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

The low vapour pressure of the chemical diiodohydroxyquinoline shall ensure that the exposure to vapours shall be negliglible and therefore it is expected that the chemical shall not exhibit repeated dose toxicity by the inhalation route.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:

From the acute dermal study results and also considering the fact that the chemical diiodohydroxyquinoline is used as a skin antiseptic it is assumed that the chemical shall not exhibit repeated dose toxicity by the dermal route in low concentrations.

Justification for classification or non-classification

The data for repeated dose toxicity by the oral route is from a long term study (2 years) wherein the TDLo was found to be greater than 120000 mg/kg body weight in humans. Given that the oral route of exposure is considered to be the most prominent route of exposure, it is concluded that the chemical shall not exhibit repeated dose toxicity via the oral, inhalation and dermal route.