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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-2
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:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Most sensitive endpoint is the 28-day repeated dose study conducted with oral administration of test substance.
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL according to ECHA guidance (practical guide 14).
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for sub acute to chronic according to ECHA guidance (practical guide 14).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats according to ECHA guidance (practical guide 14).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences according to ECHA guidance (practical guide 14).
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA guidance (practical guide 14).
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL based on GLP study carried out in accordance with an internationally recognised test method
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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Most sensitive endpoint is the 28-day repeated dose study conducted with oral administration of test substance.
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL according to ECHA guidance (practical guide 14)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for sub acute to chronic according to ECHA guidance (practical guide 14).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats according to ECHA guidance (practical guide 14).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences according to ECHA guidance (practical guide 14).
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population according to ECHA guidance (practical guide 14).
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL based on GLP study carried out in accordance with an internationally recognised test method
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No extrapolation required, dose descriptor is taken from a 28 day repeated dose study where the substance is administered orally.
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL according to ECHA guidance (practical guide 14)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value for sub acute to chronic according to ECHA guidance (practical guide 14)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats according to ECHA guidance (practical guide 14).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences according to ECHA guidance (practical guide 14).
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population according to ECHA guidance (practical guide 14).
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL based on GLP study carried out in accordance with an internationally recognised test method
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.
