Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic 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

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:
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

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
63
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
135 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
63
Dose descriptor starting point:
other: LOAEL

Workers - Hazard for the eyes

Additional information - workers

Crude 1,3 -dichloropropene was found to have an acute oral LD50 value of between 300 and 2000 mg/kg of body weight in female rats. All three animals placed on study at the high dose level of 2000 mg/kg died within two days of treatment. Based on the acute oral LD50 value of between 300 and 2000 mg/kg of body weight Crude 1,3-Dichloropropene is included in Toxicity Category 4, according to the Globally Harmonized System (GHS), (UNITED NATIONS, 2005).

Crude 1,3 -dichloropropene was found to be a skin irritant based on the outcome of Draft O.E.C.D. Testing Guideline "In Vitro Skin Irritation" study conducted with the human keratinocyte EPISKIN tissue model. The Relative Permeability reported in this study for Crude 1,3 -dichloropropene was 8.4 ± 1.3%. In an O.E.C.D. Testing Guideline No. 437, " Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants", Crude 1,3 -dichloropropene was not reported to be an eye irritant with a mean In Vitro Irritancy Score (IVIS) of 43.2 ± 9.9. Based on the outcome of an in vitro skin irritation O.E.C.D. Testing Guideline study Crude 1,3 -dichloropropene requires Classification and Labeling as R38, "Irritating to Skin". The data from an in vitro O.E.C.D. Testing Guideline No. 437 study do not support the Classification and Labeling of 1,3 -dichloropropene as an eye irritant.

Based on a Stimulation Index of 5.5 at the high concentration of Crude 1,3-dichloropropene of 50% v/v, Crude 1,3-dichloropropene is considered to be a skin sensitizer in the mouse LLNA. However, the limitations of the LLNA only allow prediction of the induction phase. The Dermal DNEL for the worker is believed to be protective of skin sensitization under Strictly Controlled Conditions encountered in the worplace.  

Crude 1,3 -dichloropropene was assessed for mutagenic potential with an O.E.C.D. 471 Testing Guideline study conducted by the preincubation method and GLP compliance. Treatment of tester strains TA 1535, TA 100 and WP2 uvrA with Crude 1,3-dichloropropene with and without rat liver derived S9 metabolic activation preparation resulted in positive mutational responses in this in vitro genotoxicity assay. 

General Population - Hazard via inhalation route

Systemic 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

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:
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

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
81 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
105
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
81 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
105
Dose descriptor starting point:
other: LOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
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

Additional information - General Population

The substance, Crude 1,3 -Dichloropropene is a Transported Intermediate handled by Strictly Controlled Conditions. Generally, no Generla Population exposure is anticipated. Dermal contact of the General Population to this volatile substance is very unlikely.