Registration Dossier
Registration Dossier
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EC number: 271-078-3 | CAS number: 68515-37-7 A complex combination of hydrocarbons produced by the esterification of phthalic anhydride with isononyl alcohol. It consists predominantly of C9 primary alcohols, C9 paraffins, and saturated and unsaturated C18 ethers and boiling in the range of approximately 120°C to 220°C (248°F to 428°F).
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
- Although “residual” interspecies variability may remain following allometric scaling, this is largely accounted for in the default assessment factor proposed for intraspecies variability.
- Following analysis of the inherent variability in human toxicokinetic and toxicodynamic parameters, a difference of 3 (close to the 90th percentile) was considered appropriate to account for variability present in worker groups while a value of 5 (equivalent to the 95th percentile) was appropriate for the general population.
The REACH Technical Guidance Document R.8 contains default assessment factors which should be applied to a modified dose descriptor in order to obtain a DNEL. These factors are multiplicative and can lead to a human chronic NAEL that is 100 or 200 fold lower than the equivalent rat subchronic NOAEL. However other guidance is available from ECETOC (2003), which supports smaller assessment factors to account for inter- and intra- species differences; leading to a human chronic NAEL that is only 24 to 40 -fold lower than an equivalent rat sub\chronic NOAEL.
The ECETOC technical report includes scientific justification for the magnitude of these assessment factors, including:
Section R.8.4.3.3 of the REACH Technical Guidance Document recognizes that the overall assessment factor applied to an experimental NOAEL when developing a DNEL is multiplicative in nature, and that “Care should be taken to avoid double counting several aspects when multiplying the individual factors.” Based on the information presented in ECETOC (2003) and summarized above, use of the standard defaults for inter- and intra- species variability contained in REACH Technical Guidance Document appears to result in “double counting”, and if used inappropriately, would lead to a large, conservative overall assessment factor.
In order to retain the scientific credibility in its DNEL setting process, we will adopt the assessment factors proposed by ECETOC (2003) when developing DNELs.
Inhalation – Worker (Long term effects – Local)
The only effect CAS#98072-31-2 is anticipated to exhibit in repeated exposure is local irritation in the respiratory system; demonstrated by CAS#68526-82-9.
Dose descriptor
A rat inhalation NOAEC of 100 mg/m3 will be used to derive the DNEL long term effects-local inhalation.
Modification of dose descriptor
Correct the NOAEC to adjust for differences in duration in the animal study (6 h) and the
worker (8 h) and light work following the TGD Figure R.8-2:
100 mg/m3 x [6 h / 8 h] x [6.7 m3 / 10 m3] x [5d / 5d] = 50.25 mg/m3
It is assumed that DCPD is similarly and efficiently (100%) absorbed after inhalation by rats and humans.
Assessment factors
Uncertainty AF Justification
Interspecies differences |
1 |
default for inhalation route |
Intraspecies differences |
3 |
default AF for workers |
Duration of exposure |
1 |
irritation expected regardless of exposure duration |
Dose-response |
1 |
default |
Overall |
3 |
|
DNELlong term local inhal = 50.25 mg/m3 / 3
= 16.75 mg/m3
Risk management measures and other occupational controls are designed to limit local irritation effects will also protect against long term local respiratory tract effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.57 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
- Although “residual” interspecies variability may remain following allometric scaling, this is largely accounted for in the default assessment factor proposed for intraspecies variability.
- Following analysis of the inherent variability in human toxicokinetic and toxicodynamic parameters, a difference of 3 (close to the 90th percentile) was considered appropriate to account for variability present in worker groups while a value of 5 (equivalent to the 95th percentile) was appropriate for the general population.
The REACH Technical Guidance Document R.8 contains default assessment factors which should be applied to a modified dose descriptor in order to obtain a DNEL. These factors are multiplicative and can lead to a human chronic NAEL that is 100 or 200 fold lower than the equivalent rat subchronic NOAEL. However other guidance is available from ECETOC (2003), which supports smaller assessment factors to account for inter- and intra- species differences; leading to a human chronic NAEL that is only 24 to 40 -fold lower than an equivalent rat sub\chronic NOAEL.
The ECETOC technical report includes scientific justification for the magnitude of these assessment factors, including:
Section R.8.4.3.3 of the REACH Technical Guidance Document recognizes that the overall assessment factor applied to an experimental NOAEL when developing a DNEL is multiplicative in nature, and that “Care should be taken to avoid double counting several aspects when multiplying the individual factors.” Based on the information presented in ECETOC (2003) and summarized above, use of the standard defaults for inter- and intra- species variability contained in REACH Technical Guidance Document appears to result in “double counting”, and if used inappropriately, would lead to a large, conservative overall assessment factor.
In order to retain the scientific credibility in its DNEL setting process, we will adopt the assessment factors proposed by ECETOC (2003) when developing DNELs.
Inhalation – General Population (Long term effects – Local)
The only effect CAS#98072-31-2 is anticipated to exhibit in repeated exposure is local irritation in the respiratory system; demonstrated by CAS#68526-82-9.
Dose descriptor
A rat inhalation NOAEC of 100 mg/m3 will be used to derive the DNEL systemic effects-local inhalation.
Modification of dose descriptor
Correct the NOAEC to adjust for differences in duration in the animal study (6 h) and the population (24 h) and light work following the TGD Figure R.8-2:
100 mg/m3 x [6 h / 24 h] x [5d / 7/] = 17.85 mg/m3
It is assumed that DCPD is similarly and efficiently (100%) absorbed after inhalation by rats and humans.
Assessment factors
Uncertainty AF Justification
Interspecies differences |
1 |
default for inhalation route |
Intraspecies differences |
5 |
default AF for population |
Duration of exposure |
1 |
irritation expected regardless of exposure duration |
Dose-response |
1 |
default |
Overall |
5 |
|
DNEL long term local nhal = 17.85 mg/m3 / 5
= 3.57 mg/m3
Risk management measures and other occupational controls are designed to limit local irritation effects will also protect against long term local respiratory tract effects.
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.
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