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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 47 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: most closely equivalent to ECHA REACH Guidance
- Overall assessment factor (AF):
- 18.75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- ECHA REACH Guidance default procedure: correction factor = 1/0.38m3/kg x 1/2 x 6.7m3/person (8h) / 10m3/person (8h)
- AF for dose response relationship:
- 0.5
- Justification:
- The default AF of 1 for NOAEL was modified because of the absence of any adverse effects at the higest dose level tested
- AF for differences in duration of exposure:
- 3
- Justification:
- The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications suggesting accumulation. Moreover in an one-generation reproduction toxicity study applying treatment periods above 28 days an NOAEL of 1000 mg/kg bw was determined for parental toxicity.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No AF applied because already implemented in the calculation of the correct starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance default AF
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality
- AF for remaining uncertainties:
- 1
- Justification:
- No AF applied
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: most closely equivalent to ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- worst case assumption: absorption after dermal exposure does not deceed absorption after oral ingestion
- AF for dose response relationship:
- 0.5
- Justification:
- The default AF of 1 for NOAEL was modified because of the absence of any adverse effects at the higest dose level tested
- AF for differences in duration of exposure:
- 3
- Justification:
- The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications suggesting accumulation. Moreover in an one-generation reproduction toxicity study applying treatment times above 28 days an NOAEL of 1000 mg/kg bw was determined for parental toxicity.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance default AF for rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance default AF
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance default AF for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality
- AF for remaining uncertainties:
- 1
- Justification:
- No AF applied
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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
The intended use of the pigment is coloration of plastic materials. As such the pigment is bound in a matrix which prevents a relevant exposure of the general population. Therefore and because of the very low toxicity DNELs for the general population were not derived.
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.
