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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-288-2 | CAS number: 41272-40-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.98 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 12.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC = (7/4 x 70)/10 [NAEC = modified starting point; 7 mg/kg = NOAEL (Culp NTP, 2004); 4 = AF interspecie; 70 kg bw = standard human body weight; 10 m^3 = default worker breathing volume in 8h]
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- From chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Scaling issues just evaluated in modified starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
1 from oral to dermal route
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- From chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Other differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- No futher uncertainties
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:
- medium hazard (no threshold derived)
Additional information - workers
The tests considered about toxicological information were performed on several salification forms at the same organic molecule; the salts are chloride, acetate and oxalate. In all cases for those end points the toxicological influence of those counter ions is negligible compared to the toxicity and the metabolic pathway of the organic molecule. Therefore all the studies can be used in read-across to assess the related end point.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.245 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 6.125 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC = (7/4 x 70)/20 [NAEC = modified starting point; 7 mg/kg = NOAEL (Culp NTP, 2005); 4 = AF interspecie; 70 kg bw = standard human body weight; 20 m^3 = default human breathing volume]
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- From chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Scaling issues just evaluated in modified starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
1 from oral to dermal route
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- From chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remainig differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.07 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
1 oral to oral
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- From chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differrences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
According to CLP regulation (EC1272/2008) Malachite Green is classified as:
Acute tox 4: H302 - Harmful if swallowed
Eye Dem 1: H318 - Causes serious eye damage
Skin Sens 1: H317 - May cause an allergic skin reaction
Repro 2: H361d - Suspected of damaging the unborn child
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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