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EC number: 240-005-7 | CAS number: 15876-39-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female Outbred Wistar in 90 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1079 .5999 mg/Kg bw/day.
Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Repeated dose toxicity: Dermal
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose dermal toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female New Zealand White rabbits in 28 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1500.0 mg/Kg bw/day.
Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is from OECD QSAR Toolbox version 3.3 and the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3, 2017
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test material: 2',4',5',7'-Tetrabromofluorescein aluminum salt
- IUPAC name: 2-(2,4,5,7-tetrabromo-3,6-dihydroxy-9H-xanthen-9-yl)benzoic acid
- Molecular formula: C20H8Br4O5.2/3Al
- Molceular weight: 1991.5992 g/mol
- Substance type: Organic - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Outbred
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- No data
- Remarks:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 1 079.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1079 .5999 mg/Kg bw/day.
- Executive summary:
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female Outbred Wistar in 90 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1079 .5999 mg/Kg bw/day.
Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((((((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and ("j"
and (
not "k")
)
)
and ("l"
and (
not "m")
)
)
and ("n"
and (
not "o")
)
)
and "p" )
and ("q"
and (
not "r")
)
)
and ("s"
and (
not "t")
)
)
and ("u"
and "v" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Phenols (Chronic toxicity) by
US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Aryl OR Aryl halide OR
Carboxylic acid OR Fused carbocyclic aromatic OR Fused saturated
heterocycles OR Phenol OR Xanthene by Organic Functional groups ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aryl OR Aryl halide OR
Carboxylic acid OR Overlapping groups OR Phenol OR Xanthene by Organic
Functional groups (nested) ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acid, aromatic attach [-COOH] OR
Alcohol, olefinic attach [-OH] OR Aliphatic Carbon [CH] OR Aliphatic
Carbon, two phenyl attach [-C-] OR Aliphatic Oxygen, two aromatic
attach [-O-] OR Aromatic Carbon [C] OR Bromine, aromatic attach [-Br] OR
Bromine, olefinic attach [-Br] OR Carbonyl, olefinic attach [-C(=O)-] OR
Carbonyl, one aromatic attach [-C(=O)-] OR Hydroxy, aromatic attach
[-OH] OR Miscellaneous sulfide (=S) or oxide (=O) OR Olefinic carbon
[=CH- or =C<] OR Oxygen, one aromatic attach [-O-] OR Oxygen, two
olefinic attach [-O-] OR Tertiary Carbon by Organic functional groups
(US EPA) ONLY
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Aromatic compound OR Aryl
bromide OR Aryl halide OR Carbonic acid derivative OR Carboxylic acid OR
Carboxylic acid derivative OR Diarylether OR Ether OR Halogen derivative
OR Heterocyclic compound OR Hydroxy compound OR Phenol by Organic
functional groups, Norbert Haider (checkmol) ONLY
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as AN2 OR AN2 >> Nucleophilic
addition to alpha, beta-unsaturated carbonyl compounds OR AN2 >>
Nucleophilic addition to alpha, beta-unsaturated carbonyl compounds >>
alpha, beta-Unsaturated Aldehydes OR AN2 >> Schiff base formation OR AN2
>> Schiff base formation >> alpha, beta-Unsaturated Aldehydes OR Michael
addition OR Michael addition >> Quinone type compounds OR Michael
addition >> Quinone type compounds >> Quinone methides OR Non-covalent
interaction OR Non-covalent interaction >> DNA intercalation OR
Non-covalent interaction >> DNA intercalation >> DNA Intercalators with
Carboxamide Side Chain OR Radical OR Radical >> Radical mechanism by ROS
formation (indirect) or direct radical attack on DNA OR Radical >>
Radical mechanism by ROS formation (indirect) or direct radical attack
on DNA >> Organic Peroxy Compounds OR Radical >> ROS formation after GSH
depletion OR Radical >> ROS formation after GSH depletion >> Quinone
methides OR SN1 OR SN1 >> Alkylation after metabolically formed
carbenium ion species OR SN1 >> Alkylation after metabolically formed
carbenium ion species >> Polycyclic Aromatic Hydrocarbon Derivatives OR
SN2 OR SN2 >> Alkylation, direct acting epoxides and related OR SN2 >>
Alkylation, direct acting epoxides and related >> Epoxides and
Aziridines OR SN2 >> Alkylation, direct acting epoxides and related
after P450-mediated metabolic activation OR SN2 >> Alkylation, direct
acting epoxides and related after P450-mediated metabolic activation >>
Polycyclic Aromatic Hydrocarbon Derivatives by DNA binding by OASIS v.1.3
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OECD
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Michael addition OR Michael
addition >> P450 Mediated Activation of Heterocyclic Ring Systems OR
Michael addition >> P450 Mediated Activation of Heterocyclic Ring
Systems >> Furans OR Michael addition >> P450 Mediated Activation to
Quinones and Quinone-type Chemicals OR Michael addition >> P450 Mediated
Activation to Quinones and Quinone-type Chemicals >> Alkyl phenols OR
Michael addition >> P450 Mediated Activation to Quinones and
Quinone-type Chemicals >> Arenes OR Michael addition >> P450 Mediated
Activation to Quinones and Quinone-type Chemicals >> Hydroquinones OR
Michael addition >> Polarised Alkenes-Michael addition OR Michael
addition >> Polarised Alkenes-Michael addition >> Alpha, beta-
unsaturated amides OR Michael addition >> Polarised Alkenes-Michael
addition >> Alpha, beta- unsaturated esters OR SN1 OR SN1 >> Iminium Ion
Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
OR SN2 OR SN2 >> Epoxidation of Aliphatic Alkenes OR SN2 >> Epoxidation
of Aliphatic Alkenes >> Halogenated polarised alkenes by DNA binding by
OECD
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding alerts for Chromosomal aberration by OASIS v1.1
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as AN2 OR AN2 >> Michael addition
to alpha, beta-unsaturated acids and esters OR AN2 >> Michael addition
to alpha, beta-unsaturated acids and esters >> alpha, beta - Unsaturated
Carboxylic Acids and Esters OR AN2 >> Michael-type addition to quinoid
structures OR AN2 >> Michael-type addition to quinoid structures >>
Phenols by Protein binding alerts for Chromosomal aberration by OASIS
v1.1
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding alerts for skin sensitization by OASIS v1.3
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Azlactones and unsaturated lactone
derivatives OR Michael Addition OR Michael Addition >> Michael addition
on conjugated systems with electron withdrawing group OR Michael
Addition >> Michael addition on conjugated systems with electron
withdrawing group >> alpha,beta-Carbonyl compounds with polarized double
bonds OR Nucleophilic addition OR Nucleophilic addition >> Addition to
carbon-hetero double bonds OR Nucleophilic addition >> Addition to
carbon-hetero double bonds >> Ketones OR Schiff base formation OR Schiff
base formation >> Benzoyl Schiff base formation OR Schiff base formation
>> Benzoyl Schiff base formation >> Benzoyl phosphine oxides OR SNAr OR
SNAr >> Nucleophilic aromatic substitution on activated aryl and
heteroaryl compounds OR SNAr >> Nucleophilic aromatic substitution on
activated aryl and heteroaryl compounds >> Activated aryl and heteroaryl
compounds by Protein binding alerts for skin sensitization by OASIS v1.3
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as No alert found by Respiratory
sensitisation
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Michael Addition OR Michael
Addition >> Polarised alkenes OR Michael Addition >> Polarised alkenes
>> Indigotine and related OR Pro-SN2 OR Pro-SN2 >> Pro-ring opening SN2
OR Pro-SN2 >> Pro-ring opening SN2 >> Vinyl benzenes by Respiratory
sensitisation
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Not bioavailable by Lipinski
Rule Oasis ONLY
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Halogens AND Non-Metals by
Groups of elements
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as Metalloids by Groups of elements
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 16
- Oxygen O AND Group 17 - Halogens Br AND Group 17 - Halogens
F,Cl,Br,I,At by Chemical elements
Domain
logical expression index: "t"
Referential
boundary: The
target chemical should be classified as Group 15 - Nitrogen N OR Group
15 - Phosphorus P by Chemical elements
Domain
logical expression index: "u"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 5.14
Domain
logical expression index: "v"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 9.91
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 079.6 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from OECD QSAR toolbox 3.3
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is from OECD QSAR Toolbox version 3.3 and the supporting QMRF report has been attached
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3, 2017
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test material: 2',4',5',7'-Tetrabromofluorescein aluminum salt
- IUPAC name: 2-(2,4,5,7-tetrabromo-3,6-dihydroxy-9H-xanthen-9-yl)benzoic acid
- Molecular formula: C20H8Br4O5.2/3Al
- Molceular weight: 1991.5992 g/mol
- Substance type: Organic - Species:
- rabbit
- Strain:
- New Zealand White
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- No data
- Remarks:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1500.0 mg/Kg bw/day.
- Executive summary:
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose dermal toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female New Zealand White rabbits in 28 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1500.0 mg/Kg bw/day.
Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
(((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and ("j"
and "k" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Phenols (Chronic toxicity) by
US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Aryl OR Aryl halide OR
Carboxylic acid OR Fused carbocyclic aromatic OR Fused saturated
heterocycles OR Phenol OR Xanthene by Organic Functional groups ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aryl OR Aryl halide OR
Carboxylic acid OR Overlapping groups OR Phenol OR Xanthene by Organic
Functional groups (nested) ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acid, aromatic attach [-COOH] OR
Alcohol, olefinic attach [-OH] OR Aliphatic Carbon [CH] OR Aliphatic
Carbon, two phenyl attach [-C-] OR Aliphatic Oxygen, two aromatic
attach [-O-] OR Aromatic Carbon [C] OR Bromine, aromatic attach [-Br] OR
Bromine, olefinic attach [-Br] OR Carbonyl, olefinic attach [-C(=O)-] OR
Carbonyl, one aromatic attach [-C(=O)-] OR Hydroxy, aromatic attach
[-OH] OR Miscellaneous sulfide (=S) or oxide (=O) OR Olefinic carbon
[=CH- or =C<] OR Oxygen, one aromatic attach [-O-] OR Oxygen, two
olefinic attach [-O-] OR Tertiary Carbon by Organic functional groups
(US EPA) ONLY
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Aromatic compound OR Aryl
bromide OR Aryl halide OR Carbonic acid derivative OR Carboxylic acid OR
Carboxylic acid derivative OR Diarylether OR Ether OR Halogen derivative
OR Heterocyclic compound OR Hydroxy compound OR Phenol by Organic
functional groups, Norbert Haider (checkmol) ONLY
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as SN1 OR SN1 >> Alkylation after
metabolically formed carbenium ion species OR SN1 >> Alkylation after
metabolically formed carbenium ion species >> Polycyclic Aromatic
Hydrocarbon Derivatives OR SN2 OR SN2 >> Alkylation, direct acting
epoxides and related after P450-mediated metabolic activation OR SN2 >>
Alkylation, direct acting epoxides and related after P450-mediated
metabolic activation >> Polycyclic Aromatic Hydrocarbon Derivatives by
DNA binding by OASIS v.1.3
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.3
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Michael Addition OR Michael
Addition >> Michael addition on conjugated systems with electron
withdrawing group OR Michael Addition >> Michael addition on conjugated
systems with electron withdrawing group >> alpha,beta-Carbonyl compounds
with polarized double bonds OR SN2 OR SN2 >> SN2 Reaction at a sp3
carbon atom OR SN2 >> SN2 Reaction at a sp3 carbon atom >> Activated
alkyl esters and thioesters OR SNAr OR SNAr >> Nucleophilic aromatic
substitution on activated aryl and heteroaryl compounds OR SNAr >>
Nucleophilic aromatic substitution on activated aryl and heteroaryl
compounds >> Activated aryl and heteroaryl compounds by Protein binding
by OASIS v1.3
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log BCF max which is >= 2.28
log(L/kg wet)
Domain
logical expression index: "k"
Parametric
boundary:The
target chemical should have a value of log BCF max which is <= 4.39
log(L/kg wet)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Data is from K2 OECD QSAR Toolbox 3.3
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Prediction model based estimation and data from read across chemicals have been reviewed to determine the toxic nature of 2',4',5',7'- Tetrabromofluorescein aluminum salt upon repeated exposure by oral and dermal route of exposure. The studies are as mentioned below:
Repeated dose toxicity: Oral
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female Outbred Wistar in 90 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1079 .5999 mg/Kg bw/day.
Repeated dose oral toxicity study of structurally similar read across chemical D&C Red No. 28 ( RA CAS no 18472 -87 -2; IUPAC name: 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one ) was performed in rats. Fischer-344 (F-344) male rats were treated with D&C Red No. 28 orally in diet in the concentration of 500 mg/kg/day. The animals were observed for changes in body weight and excretion of the dye in urine of treated animals. Increase in body weight gain was observed in treated rats over the 14 days observation period. 8-week-old rats weighed 168 g±6 g and by 10 weeks they weighed 225 g±10 g. As there is no control in the study the effect were not supposed to be treatment related. Daily intake was observed to be 500 mg/kg for 14 days. Therefore, the No Observed Adverse Effect Level (NOAEL) was considered to be 500 mg/kg/day when Fischer-344 (F-344) male rats were treated with D&C Red No. 28.
In another repeated dose oral toxicity study performed as part of the evaluation of teratogenicity for structurally similar read across chemical, the toxicity of Phloxine (RA CAS no 6441 -77 -6; IUPAC name: Food Dye Red No. 104) was studied using female Wistar rats. The rats were orally exposed to Phloxine via their diet at a dosage of 0, 03, 1.0 or 3.0%. (0, 300, 1000and 3000 mg/kg bw/day). The animals were observed for clinical signs, body weight and food consumption changes, food efficiency and utrine weight. No signs of toxicity were noted during the period of pregnancy. At the highest dose level of 3000 mg/Kg, a slight depression of weight gain was noted. No marked changes in body weight were noted in 300 and 1000 mg/Kg groups. The net amounts of phloxine ingested daily during pregnancy were 2870 mg/kg for 3000 mg/Kg group, 920 mg/kg for 1000 mg/Kg group and 280 mg/kg for 300 mg/Kg group, respectively. At 3000 mg/Kg, a decrease in food efficiency were observed. No significant differences between the phloxine-treated and control groups were found in the uterus weight at the studied dose levels. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) was considered to be 3000 mg/kgbw/day in the pregnant female Wistar rats when they were orally exposed to Phloxine (Food Red No. 104) during gestation.
Repeated dose toxicity: Inhalation
The melting point 2',4',5',7'- Tetrabromofluorescein aluminum salt is >300 C. This suggests that dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido- 3-oxoxanthen-9-yl)benzoate] decomposes between 334.5 °C -338 °C at 972.1hPa without melting and does not exhibit very high vapour pressure. Inhalation is therefore not the likely route of exposure and hence this end point is considered for waiver.
Repeated dose toxicity: Dermal
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose dermal toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female New Zealand White rabbits in 28 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1500.0 mg/Kg bw/day.
Combined repeated dose & carcinogenicity by the dermal route was performed to determine the dermal toxic nature of structurally similar read across chemical 2',4',5',7'-Tetrabromofluorescein (RA CAS no 15086 -94 -9) upon repeated application. The test chemical was applied to the clipped dorsal area mice. The animals were observed for mortality, clinical signs and gross pathology and histopathology was performed. The percent survival of the treated mice changed with the duration of the treatment. The survival was 97% in 4 months, 93% in 10 months, 68% in 12 months and 50% in 18 months respectively. The incidence of extramedullary hematopoesis of the spleen (5 male and 5 females: 10%) in the test group was consistent with that found in the distilled water vehicle control groups. The incidence in the three distilled water control groups was 13 % , 18 % , and 22 % for a mean of 17.7 % . The test group did not show a greater incidence than a control group. The incidence of ectoparasitism was greater in the dye treated group than found in the vehicle controls. This increase in skin mite infestation may have contributed to the increase in epidermal change dermatitis, acanthosis, and hyperkeratosis observed in the dye treated groups. Although the number of neoplasias involving the mammary glands or internal organs was noted in the test group, there was, however, no apparent change in their pattern which could be attributed to the dermal application of the test dye compound. The incidence and severity of lesions of interstitial nephritis, cystitis, amyloidosis, and bronchopneumonia though observed in the test groups but there were no significant variations that could be attributed to application of the test compound. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound 2',4',5',7'-Tetrabromofluorescein is considered to be 140.1 mg when ICR mice were exposed with the test compound for 473 days.
Based on the data available for the target chemical and its read across, 2',4',5',7'-Tetrabromofluorescein aluminum salt does not exhibit toxicity upon repeated exposure by oral and dermal route of exposure and hence it is not likely to classify as toxic as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical and its read across, 2',4',5',7'-Tetrabromofluorescein aluminum salt (CAS no 15876 -39 -8) does not exhibit toxicity upon repeated exposure by oral and dermal route of exposure and hence it is not likely to classify as toxic as per the criteria mentioned in CLP regulation.
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