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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.2 mg/m³
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEL

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:
medium hazard (no threshold derived)

Additional information - workers

Since the cyclohexylamine data are recently reviewed by the Health Council of the Netherlands, 2001, an a health based TWA of 5 mg/m3 was recommended by the committee this assessment was taken as a base for the DNEL calculation.

Starting point: The most sensitive effect for systemic toxicity is repeated dose toxicity observed at doses higher than 15 mg/kg/day. An NOAEL of 15 mg/kg/day was observed in a chronic 2 years study in rats and higher NOAEL values were reported for mice and monkeys.

Assessment factors applied by the NL Health Council:

- Allometric scaling: 4

- Overall factors for intra- and interspecies: 9

This results in an overall Assessment factor of 4 x 9 = 36

Assuming a 70 kg worker inhales 10 m3 during an 8-hour working day and retention of 100% this leads to a value of 2.9 mg/m3. The NL Health Council applied the preferred value approach and derived a health-based occupational exposure limit of 5 mg/m3.

Based on the above mentioned parameters the following DNELs are derived for long term systemic toxicity:

Oral and dermal exposure: (15 mg/kg/day / 36) = 0.4 mg/kg

Inhalation: 5 mg/m3

For peak short term exposure the long term value might be exceeded by a factor of 2 resulting in the following DNELs for short term systemic toxicity:

Oral and dermal exposure: (0.4 mg/kg x 2) = 0.8 mg/kg

Inhalation: 8.2 mg/m3 (2 ml/m3; this value is also recommended by the German MAK commission as the long term MAK value)

Cyclohexylamine is labeled with R34 (corrosive); according to REACH TGD "Guidance on information requirements and chemical safety assessment, Part E: Risk Characterization, May 2008" this translates to the “moderate hazard band”

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Value:
1.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
36
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Systemic DNELs for the general population were based on the respective DNEL for worker by applying and additional factor (based on the intraspecies factor mentioned in the REACH TGD for workers (5) and for the general population (10) a factor of 2 between worker and the general population is derived). This results in an overall assessment factor for the general population of (4 x 9 x 2 )= 72

The following oral and dermal DNEL were derived:

long term systemic toxicity: (15 mg/kg/day / 72) = 0.2 mg/kg

short term systemic toxicity: (long-term DNEL 0.2 mg/kg x 2) = 0.4 mg/kg

The following inhalation DNEL were derived:

Assuming a 60 kg worker inhales 20 m3 during a 24h day.

long term systemic toxicity: (15 mg/kg/day / 72 x 60 kg/person / 20 m3 air/day) = 0.6 mg/m3

short term systemic toxicity: (long-ertm DNEL 0.6 mg/m3 x 2) = 1.2 mg/m3

Concerning the local effects: the Compound is labeled with R34 (corrosive); according to REACH TGD "Guidance on information requirements and chemical safety assessment, Part E: Risk Characterization, May 2008" this translates to the “moderate hazard band”