Registration Dossier
Registration Dossier
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EC number: 271-867-2 | CAS number: 68610-51-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). In accordance with ECHA Guidance R-8, the oral NOAEL for the rabbit (15 mg/kg bw) in a first step is transferred to humans with a factor of 2.4 for allometric scaling. With help of a standard human body weight (70 kg) and a default human breathing volume referring to the specific conditions of the respective population (10 m3 for workers in 8h and light activity), this dose is then translated into an air concentration.
Therefore, NAECcorr_inh = (15/2.4) x (70/10) = 43.75 mg/m3
As a worst case, oral absorption in rabbits is assumed to be 50% and inhalation absorption in humans is assumed to be 100%. Therefore, NAECcorr_inh = 43.75 x 50/100 = 21.88 mg/m3. See toxicokinetics summary in IUCLID Chapter 7.1 for justification of absorption factors.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required. Already taken into account in calculation for modifying the dose descriptor starting point (see above).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming that oral absorption in rabbits is 50% and that dermal absorption in humans is 10% (see toxicokinetics summary in IUCLID Chapter 7.1). Therefore dose descriptor after route to route extrapolation is 15 x 50/10 = 75 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default factor (rabbit to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The NOAEL from the prenatal developmental toxicity study was selected as starting point for deriving the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL.
In the absence of classification for systemic and local effects after acute oral and dermal exposure to phenol, 4-methyl, reaction products with dicyclopentadiene and isobutylene for acute toxicity, no acute DNELs are considered applicable.
In the absence of local effects after repeated exposure to phenyl, 4-methyl-, reaction products with dicyclopentadiene and isobutylene, no long-term DNELs for local effects are considered applicable.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.94 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). In accordance with ECHA Guidance R-8, the oral NOAEL for the rabbit (15 mg/kg bw) in a first step is transferred to humans with a factor of 2.4 for allometric scaling. With help of a standard human body weight (70 kg) and a default human breathing volume referring to the specific conditions of the respective population (20 m3 for general public in 24 h hours and basal caloric demand), this dose is then translated into an air concentration.
Therefore, NAECcorr_inh = (15/2.4) x (70/20) = 21.88 mg/m3
As a worst case, oral absorption in rabbits is assumed to be 50% and inhalation absorption in humans is assumed to be 100%. Therefore, NAECcorr_inh = 21.88 x 50/100 = 10.94 mg/m3. See toxicokinetics summary in IUCLID Chapter 7.1 for justification of absorption factors.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already taken into account in calculation for modifying the dose descriptor starting point (see above).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local 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 via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming that oral absorption in rabbits is 50% and that dermal absorption in humans is 10% (see toxicokinetics summary in IUCLID Chapter 7.1). Therefore dose descriptor after route to route extrapolation is 15 x 50/10 = 75 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default factor (rabbit to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral absorption (rabbit) = oral absorption (human)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default factor (rabbit to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there are sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The NOAEL from the prenatal developmental toxicity study was selected as starting point for deriving the long-term systemic inhalation DNEL, the long-term systemic dermal DNEL and the long-term systemic oral DNEL.
In the absence of classification for systemic and local effects after acute oral and dermal exposure to phenol, 4-methyl, reaction products with dicyclopentadiene and isobutylene for acute toxicity, no acute DNELs are considered applicable.
In the absence of local effects after repeated exposure to phenyl, 4-methyl-, reaction products with dicyclopentadiene and isobutylene, no long-term DNELs for local effects are considered applicable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
