Registration Dossier

Administrative data

Description of key information

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.