Registration Dossier
Registration Dossier
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EC number: 445-090-6 | CAS number: 5614-37-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 422.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No effect concentration from 90-day study = 840 mg/m3. Adjustment for daily exposure = 8 hours (workers)/6 hours (rat exposure in subchronic study). Adjustment for respirometric volume of rat at rest vs worker undertaking light activity = 10/6.7. Starting point is therefore: 840*(6/8)*(6.7/10) = 422.0 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No adjustment made for dose response - the starting point is considered to be a true no effect level.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from sub-chronic (e.g. 90-day study) to chronic exposure. Refer to Table R8-5 of the ECHA guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling already accounted for in the route-to-route extrapolation (differenced in daily exposure duration and respirometric rates already incorporated in the extrapolation from rat exposure to anticipated worker exposure).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining interspecies differences. Refer to table R8-6 in the ECHA guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for Intraspecies correction for workers. Refer to table R8-6 of the ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- No correction made as the study from which the starting point (NOEL) was taken is considered reliable (performed according to international guidelines and in compliance with GLP).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.448 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Value:
- 44.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There is no data which indicates that the bioavailability or systemic absorbtion of the substance is greater by the dermal route than by the oral route (in actual fact, on the basis of the effects seen in the acute studies, absorbtion following oral exposure seems to be greater than by dermal exposure); on this basis the NOEL from the oral study is used as the starting point for the dermal DNEL, without modification.
Correction for differences between human and experimental exposure conditions (workers): 1.4
- AF for dose response relationship:
- 1
- Justification:
- No adjustment made for dose-response relationship because the starting point is considered a genuine No Observed Adverse Effect Level; no clinical signs were recorded during / after dosing, and no abnormalities were reported during the post-mortem examinations.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from sub-chronic (e.g. 90-day study) to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default Allometric Scaling factor for conversion between rats and humans. Refer to table R8-3 in the ECHA guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining interspecies differences. Refer to table R8-6 in the ECHA guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for Intraspecies correction for workers. Refer to table R8-6 of the ECHA guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- No correction made as the study from which the starting point (NOEL) was taken is considered reliable (performed according to international guidelines and in compliance with GLP).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
The substance is considered to present a low hazard for local effects following dermal or eye contact in accordance with ECHA "Guidance on information requirements and Chemical Safety Assesment, Part E: Risk Characterisation". The guidance indicates that a substance classified as Eye irritation category 2 (H319) or Skin irritation category 2 (H315) should be considered a low hazard for qualitative risk assessment.
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
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.
