Registration Dossier
Registration Dossier
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EC number: 262-679-1 | CAS number: 61260-55-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Hazard assessment of systemic effects is sufficiently covered by hazard assessment of local effects. The available data on skin and eye irritation/corrosion indicate that the test substance fulfils the GHS criteria for classification as Skin Corrosive Category 1C and Eye Damage Category 1. Furthermore the available data indicates that dermal or inhalative exposure will primarily result in local effects due to the irritant/corrosive properties. Therefore, no systemic effects are expected.
Based on water solubility (1.76 g/L) and partition coefficient (log Pow = -1.3) alone, the skin penetration potential of the test substance is expected to be low due to its hydrophilicity, which limits penetration into the stratum corneum. Dermal absorption may be possible only when the skin is already hurt by corrosive effects. Due to the corrosive properties, dermal contact has to be avoided by use of appropriate PPE for dermal protection. Thus, human exposure via the dermal route is unlikely to occur under normal working conditions as appropriate operational conditions and necessary risk management measures are in place. Taking into account the corresponding operational conditions and necessary risk management measures, also human exposure via the inhalation route is unlikely to occur under normal working conditions.
Taking into account the classification of the substance it is
concluded that the substance poses a medium hazard [ECHA Guidance on
information requirements and chemical safety assessment, Part E: Risk
Characterization, Nov 2012].
DNELs for irritation/ corrosion can only be derived if dose-response
information is available. Acute, sub-acute or sub-chronic toxicity
studies in animals by the dermal or inhalation route may be able to
provide this information, provided that symptoms of irritation/corrosion
are recorded and reported in relevant studies [ECHA Guidance on
information requirements and chemical safety assessment, Chapter R.8:
Characterization of dose (concentration)-response for human health, Nov
2012]. For the substance no dose-response information in the form of
acute, sub-acute or sub-chronic toxicity studies in animals by the
dermal or inhalation route are available. Thus, in agreement with the
ECHA Guidance Chapter R.8, from eye/skin irritation/corrosion studies no
dose/concentration-response relationship can be obtained and therefore
no DNELs for local effects can be derived. The data set of the substance
indicates that the local irritant/corrosive properties are predominant
and potential systemic toxic effects are concluded to be secondary.
Thus, DNELs to assess the systemic exposure of the worker are not being
derived.
When no DNELs can be derived, a more qualitative approach to assessing
and controlling these risks is appropriate.
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
Since exposure for the general public is precluded, DNELs for the general population are not relevant and thus not derived.
Additional information:
N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
(HMBTAD), CAS-No. 61260-55-7, EC-No. 262-679-1 is used as a monomer for
the production of Light stabilizers 783 and 744. These light stabilizers
are authorized by EFSA for use as PPA's (polymer production aids) in
plastics. Light stabilizer 783 (CAS-No. 65447-77-0) and Light stabilizer
744 (CAS-No. 71878-19-8) has been authorized by EFSA (European Food
Safety Agency) for use in plastics come in contact with food. Both
substances are listed on Annex I of Regulation (EU) No. 10/2011 of 14
January 2011 on plastic materials and articles intended to come into
contact with food with the following items:
Light stabilizer 783 (FCM No. 716) with a SML (Specific Migration Limit)
of 30 mg/kg food whereas Light stabilizer 744 (FCM No. 740) has a SML
(Specific Migration Limit) of 3 mg/kg food.
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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