Registration Dossier
Registration Dossier
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EC number: 405-490-3 | CAS number: 613-62-7 BENZYL-2-NAPHTHYLETHER; BETA-NAPHTHYLBENZYLETHER (BON); BNE; BON; NIPAFAX BNE; SENSLON-50; ZO-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Workers - Hazard for the eyes
Additional information - workers
1. Identification of relevant dose descriptor
For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 427 mg/kg/day.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance toGuidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
Workers: NOAEL (oral) = 427 mg/kg bw =>NOAEL(corrected)= 753 mg/m3
4. Application of assessment factors
The following assessment factors were chosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation), remaining differences account for 2.5. Intraspecies differences account for a factor of 5. For exposure duration a factor of 2 is employed. Overall, assessment factors of 100 and 25 were employed for oral/dermal and inhalation route, respectively.
5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects
DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.
DNEL- acute, inhalation, local:
Not quantifiable.
DNEL- acute, dermal, systemic: The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided.
DNEL- acute, dermal, local:
Not quantifiable
DNEL- long-term, inhalation, local:
Not quantifiable.
DNEL- long-term, inhalation, systemic:
NOAEL (corrected) / Sum of assessment factors applicable
753 mg/m3 /25 = 30 mg/m3
DNEL- long-term, dermal, systemic:
NOAEL (oral) / Sum of assessment factors applicable
427 mg/kg bw / 100 = 4.3 mg/kg bw
The
dermal route is typically covered by oral route information in the
absence of data for this administration route.
DNEL- long-term, dermal, local:
Not quantifiable and not considered applicable.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
1. Identification of relevant dose descriptor
For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 427 mg/kg/day.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance toGuidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
General population: NOAEL (oral) = 427 mg/kg bw =>NOAEL(corrected)= 371 mg/m3
4. Application of assessment factors
The following assessment factors were chosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation), remaining differences account for 2.5. Intraspecies differences account for a factor of 5. For exposure duration a factor of 2 is employed. Overall, assessment factors of 200 and 50 were employed for oral/dermal and inhalation route, respectively.
5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects
DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.
DNEL- acute, inhalation, local:
Not quantifiable.
DNEL- acute, dermal, systemic: The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided.
DNEL- acute, dermal, local:
Not quantifiable
DNEL- long-term, inhalation, local:
Not quantifiable.
DNEL- long-term, inhalation, systemic:
NOAEL (corrected) / Sum of assessment factors applicable
371 mg/m3 /50 = 7.4 mg/m3
DNEL- long-term, dermal, systemic:
NOAEL (oral) / Sum of assessment factors applicable
427 mg/kg bw / 200 = 2.1 mg/kg bw
The
dermal route is typically covered by oral route information in the
absence of data for this administration route.
DNEL- long-term, dermal, local:
Not quantifiable and not considered applicable.
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