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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
89.957 mg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
70
Modified dose descriptor starting point:
NOAEC
Value:
6 296.986 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
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:
51.02 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
70
Modified dose descriptor starting point:
NOAEL
Value:
3 571.425 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
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

Toxicokinetics:

In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the colorFD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats.None of the colors was found in the urine.The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.

 

Thus, it can be concluded that the color FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential. There are certain reports though which indicate that these colorsare capable of producing tumors in rats at the site of subcutaneous injections repeated over periods of months.

Acute Toxicity (Oral, Dermal, Inhalation):

From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to exhibit acute toxicity by the oral, inhalation and dermal route of exposure. Thus, the chemical is not classified for acute toxicity by either of the 3 routes of exposure.

Irritation effect (Skin & Eye):

From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to cause irritation to skin and eyes. Thus, the chemical is not classified for skin and eye irritation.

Skin sensitization:

Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium, disodium salt is estimated to be non-sensitising in a Guinea pig maximisation test.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22.183 mg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEC
Value:
3 105.587 mg/m³
AF for intraspecies differences:
10
Justification:
general population default
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:
25.51 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEL
Value:
3 571.425 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
General population default
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:
12.755 mg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
140
Modified dose descriptor starting point:
NOAEL
Value:
1 785.713 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population default
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

DNEL derivation

From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to exhibit acute toxicity by the oral, inhalation and dermal route of exposure. Thus, the chemical is not classified for acute toxicity by either of the 3 routes of exposure. The chemical is also not likely to exhibit toxic effects by the repeated oral route of exposure. The chemical is not likely to be carcinogenic. It is however likely to have mutagenic effects

A standard approach to deriving DNEL values has been to use the carcinogenecity dataset (oral route) and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 7142.857 mg/kg bw/d in oral category.