Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

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

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.23 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Worker-DNEL long-term for dermal route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 8 mg/m3 (SCOEL/SUM/16, 2003)

 

Correction of starting point:

Route of exposure (inhalation versus dermal exposure): OEL of 8 mg/m3 is converted to 80 mg/person/day assuming a breathing volume of 10 m3 in workers.

Similar exposure conditions (occupational exposure during 8 h shift).

Average person weight of 65 kg

 

8 mg/m3 x 10 m3/d /65 kg= 1.23 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure:

Assessment factors have been included in derivation of OEL, therefore no further assessment factor

 

Overall assessment factor: 1

 

DNEL worker long-term dermal systemic = 1.23 mg/kg bw/day

 

 

Worker-DNEL long-term for inhalation route-systemic

Relevant dose-descriptor for the endpoint concerned: SCOEL (2003) used the 90 day NOAEC of 5 ppm (20 mg/m3) (Sandage, 1961). “Although this was a well-designed and wide-ranging study, the SCOEL felt that limited reporting of results, especially regarding irritation of the upper respiratory tract, was a difficulty. However, no significant systemic toxicity seems likely to have been produced in any of the three species at this level.”

This approach by SCOEL was supported by the Hoffmann et al. 2001 subacute inhalation study which specifically addressed local effects in the respiratory tract and concluded on a NOAEC of 96 mg/m3.

Assessment factors relating to the extrapolation procedure:

According to SCOEL, an uncertainty factor of 2 was applied to allow for the absence of human data, but taking into account a 24h/d exposure of monkeys. Taking into account the preferred value approach, an 8-hour TWA of 2 ppm (7.8 mg/m3) is recommended. [5ppm/2 =2 ppm, rounded]

 

DNEL worker long-term inhalation systemic = 7.8 mg/m3 (2 ppm)

 

Worker-DNEL acute for inhalation route-local

According to SCOEL, it was judged that ais required to protect against upper respiratory tract irritation. There are no human data to suggest a particular value for the, but on the basis of animal data a STEL (15 min) of 4 ppm was recommended.

 

DNEL worker acute inhalation local: 15.6 mg/m3 (4 ppm)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.32 mg/m³
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Data were taken from phenol dossier - read across appreach was chosen because the content of phenol in the registered substance could be up to 50% (w/w).

General population -DNEL long-term for dermal route-systemic

Relevant dose-descriptor for the endpoint concerned: OEL of 7.8 mg/m3 (SCOEL/SUM/16, 2003), rounded up to 8

 

Correction of starting point:

Route of exposure (inhalation versus dermal exposure): the OEL of 8 mg/m³ is converted to 160 mg/person/day assuming a breathing volume of 20 m3 in general population

Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33

Average person weight of 65 kg

 

8mg/m3 x 20 m3/d x 0.33 /65 kg= 0.81 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure:

Interspecies differences: not necessary as OEL was staring point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

 

Overall assessment factor: 2

DNEL general population chronic dermal systemic: 0.4 mg/kg bw/day

 

 

General population -DNEL long-term for inhalation route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 7.8 mg/m3 (SCOEL/SUM/16, 2003), rounded up to 8

 

Correction of starting point:

Same route of exposure.

Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.

 

8mg/m3 x 0.33 = 2.64 mg/m3

 

Assessment factors relating to the extrapolation procedure:

Interspecies differences: not necessary as OEL was starting point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

 

Overall assessment factor: 2

DNEL general population long-term inhalation systemic = 1.32 mg/m3

 

 

General population-DNEL long-term for oral route-systemic

Relevant dose-descriptor for the endpoint concerned: OEL of 7.8 mg/m3 (SCOEL/SUM/16, 2003), rounded up to 8

 

Correction of starting point:

Route of exposure (inhalation versus oral exposure): the OEL of 8 mg/m3 is converted to 160 mg/person/day assuming a breathing volume of 20 m3 in general population;

Exposure conditions (occupational exposure versus continuous exposure): Daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.

Average person weight of 65 kg

 

8mg/m3 x 20 m3/d x 0.33 /65 kg= 0.81 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure:

Interspecies differences: not necessary as OEL was starting point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

 

Overall assessment factor: 2

DNEL general population long-term oral systemic: 0.4 mg/kg bw/day