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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 471-920-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - 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
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 417.36 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: EC 3
- AF for dose response relationship:
- 1
- Justification:
- Key study used a dose range that demonstrated a clear dose-response relationship.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- RE.8 Guidance: “since local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)”.
- AF for other interspecies differences:
- 1
- Justification:
- The matrix, mineral oil, for the product is not the same as the experimental conditions, acetone:olive oil (4:1) but is considered not to enhance penetration. Mineral oil that is ingested is excreted virtually unchanged, which indicates very low absorption
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- Only trained operators in controlled environments may be potentially exposed
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
There were no systemic effects noted in a 28-day repeat dose toxicology study using the oral dose route (Dhinsa et al, 2007) and no systemic effects noted in an acute dermal toxicity study (Mullaney, 2006).. The ECHA R8 guidance document states on page 157, “In case there was no effect at any of the exposure ranges, the study should not be used for derivation of the NOAEL, because there is no need to set a DNEL.” Thus as there were no systemic effects via the oral or dermal routes then the DNEL does not need to be calculated.
Furthermore no local effects were noted in either the repeat dose study or the acute irritation studies.
The substance is classified for skin sensitisation therefore an acute local dermal DNEL is calculated.
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 were no systemic effects noted in a 28-day repeat dose toxicology study using the oral dose route (Dhinsa et al, 2007) and no systemic effects noted in an acute dermal toxicity study (Mullaney, 2006).. The ECHA R8 guidance document states on page 157, “In case there was no effect at any of the exposure ranges, the study should not be used for derivation of the NOAEL, because there is no need to set a DNEL.” Thus as there were no systemic effects via the oral or dermal routes then the DNEL does not need to be calculated.
In the consumer final products, the substance is always present at less than 1%. As there is no skin sensitizer classification for the final consumer product a local DNEL is not required.
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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