Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-407-2 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
An extrapolation is needed to convert oral exposures in the 28 day study (NOAEL: expressed as mg/kg/bw) to a dose descriptor relevant for inhalation exposures (NOAEC expressed as mg/m3).
This is calculated based on the methods described in the ECHA guidance document: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14
https://echa.europa.eu/documents/10162/13655/pg_14_on_hazard_endpoint_en.pdf
Workers:
Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38m3/kg/d)*0.67*(ABSoral/ABSinhuman)
This yields a NOECcorr of 50 mg/kg/d*(1/0.38 m3/kg/d)*0.67*(0.5*1)
= 50 * 2.63 * 0.67 * 0.5
= 44 mg/m3= NOECcorr Workers
Assessment factors were calculated in accordance with the 2008 ECHA technical guidance document R.8 (1).
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- A time-scaling factor for concentration-time correction should be applied for in case where the starting point is an inhalatory NOAEC and when the experimental exposure conditions (e.g. 6h /d) for the inhalation study do not equal the human exposure conditions (e.g. workers 8h/d, general p. 24 h/d). The oral repeated dose study was used for NOEC derivation, thus the time scaling factor is not used for the NOEC correction.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default - worker
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient to determine health outcomes
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
DNELs for acute effects are recommended to be derived if an acute toxicity hazard (leading to classification and labelling) has been identified and there is a potential for high peak exposure (R.8. 1.2.5, p. 16). PACM Adduct is classified for acute effects of skin sensitisation and corrosion, and is therefore anticipated to be a respiratory irritant.
Concerning exposure to PACM Adduct, in the scenarios reported by users, there may be opportunities for short intermittent dermal or inhalation exposure in the workplace, such as during sampling or transferring material. The low vapour pressure of the substance maybe a mitigating factor in exposures. Oral exposure is deemed unlikely.
According to the ECHA Guidance, Appendix R 8.8, there is “no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by more conservative long-term systemic DNELs” (p. 106).
One well-established method used to estimate an acute threshold limit value (TLV) is the multiplication of the long-term DNEL by a factor of 3 (Guidance R.8, Appendix R.8.8, p. 110, 2008, equivalent to dividing by 0.33 as required in the IUCLID5 format).
Therefore the following Acute Systemic DNELs are derived:
Worker:
Acute Systemic Inhalation:0.58 x 3 =1.74 mg/m3
It should be noted that, at exposures to these levels, a local irritant effect may already be obvious to the user. The amelioration of local skin/eye risks should provide an adequate degree of safety from systemic effects.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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
There are no consumer uses and exposure of the general population is not anticipated as the substance is matrix-bound after use.
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.
