Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.996 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Value:
299.737 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.695 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Value:
341.7 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Toxicokinetics:

In vitro dermal/percutaneous absorption study with radiolabelled[14C] 4-chlororesorcinol was conducted ondermatomed pig skin, 380 μm thickness. The total recovery of radioactivity was 103% (with hydrogen peroxide) and 107% (without hydrogen peroxide).[14C] 4-chlororesorcinol dissolved in the vehicle hydrogen peroxide and water exhibited low dermal penetration of the test substance.

 

Acute Toxicity (Oral, Dermal, Inhalation) :

Acute toxicity oral:

Acute oral toxicity study was conducted on male and female CFY strain rats to study the toxic nature of the test material 4-chlororesorcinol. The acute oral median lethal dose (LD50) of 4-chlororesorcinol in CFY male and female rats is found to be 369 (314-433) mg/kg bw.

Acute Toxicity Inhalation:Vapour pressure of test substance 4-Chlororesorcinol is found to be 0.0012 mm Hg at 25 °C. This value is equivalent to 0.1599 Pascal at 25°C. Considering this low vapour pressure values, this end point was considered for waiver

Acute toxicity dermal:

Based on the QSAR prediction done for acute toxicity of 4-chlororesorcinol via dermal route, the LD50 value is estimated to be 3437.57 mg/kg bw on rabbits. Thus it can be concluded that 4-chlororesorcinol is considered to be not classified as per criteria of CLP regulation.

Irritation effect (Skin & Eye) :

The available data indicates that the substance 4-Chlororesorcinol is likely to classify as a skin and eye irritant according to criteria of the CLP regulation.

Skin Senitization :

The available study indicates that the substance4-Chlororesorcinolis likely to be classified as a skin sensitiser.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.232 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC
Value:
147.826 mg/m³
AF for intraspecies differences:
10
Justification:
general population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.417 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
170 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
General population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.833 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
340 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

4-chlororesorcinol exhibits acute toxicity by only oral route of exposureand thus will be considered in acute toxic category for classification. 4-chlororesorcinolis found to be irritating to skin and eye, thus leading to a conclusion that the target will be irritant to skin as well as eye.  Available studies indicate that the chemical does not exhibit genotoxicity and is not a reproductive toxin within the dose levels mentioned in the end points 

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 reproductive toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of680mg/kg bw/d in dermal category.