Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 157.895 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
other: TDLo
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 000 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
other: TDLo
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - workers

From the available study results as well as using the QSAR prediction approach, it is concluded that the chemical diiodohydroxyquinoline shall not exhibit acute toxicity by the oral, inhalation and dermal route in the concentrations mentioned in the study end points.

Diiodohydroxyquinoline does not shows irritation potential to the skin and eye of rabbit in the concentrations reported in the study results. Diiodohydroxyquinoline was found to be non sensitizing to skin.

The chemical does not demonstrate genetic toxicity potential. Within the doses reported in the available studies, Diiodohydroxyquinoline did not exhibit reproductive toxicity potential.

In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.

In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.

 

A standard approach to deriving DNEL values would be to use the repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the TDLo 120000 mg/kg body weight by oral route

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 217.391 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
other: TDLo
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 000 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
other: TDLo
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 030 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
other: TDLo
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population

Acute toxicity

Oral

 

Sr. No

End point name

Value

Test organism

Data Source

1

LD50

4470.499 mg/kg bw

Rat

QSAR

2

LD0.1 (maximum tolerated dose)

> 40000 mg/kg bw

Rat

RTECS, ACTOR

3

LDLo

300 mg/kg bw

Cat

RTECS, SAX

 

Inhalation

This end point was considered for waiver since the vapour pressure of diiodohydroxyquinoline is very low (0.00000332 Pa at 25 deg C). Hence exposure to humans is unlikely given the very low vapour pressure; thereby justifying the data waiver using the exposure consideration.

Dermal

The acute dermal LD50 of test compound Diiodohydroxyquinoline in Wistar albino rats when applied by dermal route was found to be more than 2000 mg/kg b.wt. (> 2000 mg/kg b.wt.). From this it is concluded that the substance Diiodohydroxyquinoline is non toxic by dermal route in an acute study of 14 days for the above mentioned dose.

 

Irritation / corrosion

From the skin and eye irritation studies conducted in New Zealand White Rabbit; the chemical diiodohydroxyquinoline is found to be non-irritating to the skin and eye. 

 

Sensitisation

According to the quantitative structure activity relationship model prediction (which is considered reliable by OECD), the substance diiodohydroxyquinoline was found to be weakly sensitising to skin. However, the sensitization potential was not considered significant enough for classification.