Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 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):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to route extrapolation done
AF for dose response relationship:
1
Justification:
no other factors needed
AF for differences in duration of exposure:
2
Justification:
6 month study
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic
AF for intraspecies differences:
5
Justification:
individual variability
AF for the quality of the whole database:
1
Justification:
adequate
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Several repeated dose toxicity studies of CPC are available. In a 6-month chronic oral gavage study in the rat, CPC primarily displays local irritation and corrosion effects on the non-glandular forestomach and GI tract. Cecal distention is also commonly seen, either as a consequence of gastric irritation and inflammation, or as an alteration to the intestinal microflora. There is no evidence of systemic toxicity according to clinical chemistry, hematology and histological analysis of multiple organs. At doses above the local NOAEL for irritation, symptoms in the rats include salivation upon dosing, decreased body weights and body weight gain, and decreased food consumption. These effects are unable to be dissociated with the known histological effects of irritation and necrosis in the gastric mucosa, and the stress which the irritants engender.  Thus, there is no known systemic toxicity observed after chronic CPC administration by the oral route.

The SCCS evaluated the systemic risk of CPC as an ingredient in cosmetic products. Their 2012 conclusion, for concentrations up to 2% in selected types of formulations, is that that the use of CPC in the cosmetic product for oral and for dermal application is safe for the consumer, based on acceptable margins of safety from estimated daily intended use exposures compared to no-effect levels (9 mg/kg bw/d in rat repeated dose studies).

The Opinion of this authoritative body is extended to the worker. There is a low hazard for dermal systemic toxicity; the local toxicity hazard of CPC is due to its dermal and ocular irritation.

General Population - Hazard via inhalation route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

CPC is a substance which is found in consumer products (oral healthcare products and cosmetics, and in food applications). A risk assessment for adverse effects for these specific applications is outside the scope of the REACH regulation. Other industrial or environmental exposures to the consumer may occur via accidental releases to the environment, where dilution significantly decreases theoretical exposures. No significant systemic toxicity was identified for CPC. No local DNELs are required to be derived for the consumer in the general population.