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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 696-271-3 | 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:
- 35.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory long term, systemic
R.8 Example B. 3 Modification of the starting point
For general population (24h/d exposure)
corrected inhalatory N(L)OAEC= oral N(L)OAEL×(1/sRVrat)×(ABSoral-rat/inh-rat)×(inh-rat/ABSinh-human)
=oral N(L)OAEL×(1/sRVrat)×(ABSoral-rat/ABSinh-human)
For workers (8h/d exposure)
corrected inhalatory N(L)OAEC=oral N(L)OAEL×(1/sRVrat)×(ABSoral-rat/ABSinh-human)×(sRVhuman/wRV)
ABS: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume
OECD 422 (~57d) study on SE7B, NOEL = 1000 mg/kg bw/d
corrected inhalatory N(L)OAEC worker = 1000×(1/0.38)×(50/100)×(6.7/10) = 881.6 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- route-route concentration
- AF for other interspecies differences:
- 2.5
- Justification:
- Default from guidance
- AF for intraspecies differences:
- 5
- Justification:
- worker default
- AF for the quality of the whole database:
- 1
- Justification:
- data on substance
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal long term, system
Example B. 5 Dermal exposure; oral N(L)OAEL rat
For step b: convert oral N(L)OAEL rat (in mg/kg bw/day) into dermal N(L)OAEL rat (in mg/kg bw/day) by correcting for differences in absorption between routes (if the case) as well as for differences in dermal absorption between rats and humans (if the case):
corrected dermal N(L)OAEL=oral N(L)OAEL×(ABSoral-rat/dermal-rat)×(dermal-rat/ABSdermal-human)
OECD 422 (~57d) study on SE7B, NOEL = 1000 mg/kg bw/d
corrected dermal N(L)OAEL=1000×(50/50) = 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R. 8-3 Default - Rat AS factor
- AF for other interspecies differences:
- 2.5
- Justification:
- Default from guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default from guidance - Worker
- AF for the quality of the whole database:
- 1
- Justification:
- data on substance
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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
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:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory long term, systemic
R.8 Example B. 3 Modification of the starting point
For general population (24h/d exposure)
corrected inhalatory N(L)OAEC= oral N(L)OAEL×(1/sRVrat)×(ABSoral-rat/inh-rat)×(inh-rat/ABSinh-human)
=oral N(L)OAEL×(1/sRVrat)×(ABSoral-rat/ABSinh-human)
OECD 422 (~57d) study on SE7B, NOEL = 1000 mg/kg bw/d
corrected inhalatory N(L)OAEC general population = 1000×(1/1.15)×(50/100) = 434.8 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- route-route concentration
- AF for other interspecies differences:
- 2.5
- Justification:
- Default from guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default from guidance - general population
- AF for the quality of the whole database:
- 1
- Justification:
- data on substance
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal long term, systemic
Example B. 5 Dermal exposure; oral N(L)OAEL rat
For step b: convert oral N(L)OAEL rat (in mg/kg bw/day) into dermal N(L)OAEL rat (in mg/kg bw/day) by correcting for differences in absorption between routes (if the case) as well as for differences in dermal absorption between rats and humans (if the case):
corrected dermal N(L)OAEL=oral N(L)OAEL×(ABSoral-rat/
ABSdermal-rat)×(ABSdermal-rat/ABSdermal-human)OECD 422 (~57d) study on SE7B, NOEL = 1000 mg/kg bw/d
corrected dermal N(L)OAEL=1000×(50/50) = 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic - chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default - Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default from guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default from guidance
- AF for the quality of the whole database:
- 1
- Justification:
- data on substance
- AF for remaining uncertainties:
- 1
- Justification:
- none known
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
no effects observed in acute dermal study
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:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No starting point modification required = 1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default - Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default from guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default - General Population
- AF for the quality of the whole database:
- 1
- Justification:
- data on substance
- AF for remaining uncertainties:
- 1
- Justification:
- none known
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.
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