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EC number: 221-343-4 | CAS number: 3071-73-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See Section 1. “HYPOTHESIS FOR THE ANALOGUE APPROACH” in the attached reasoning: “7.4.1 – EC 221-343-4 – Acid Black 24 – Reasoning.pdf”
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITI ES)
See Section 2. “SOURCE AND TARGET CHEMICAL(S) – INCLUDING INFORMATION ON PURITY AND IMPURITIES” in the attached reasoning: “7.4.1 – EC 221-343-4 – Acid Black 24 – Reasoning.pdf”
3. ANALOGUE APPROACH JUSTIFICATION
See section 3. “JUSTIFICATION FOR THE ANALOGUE APPROACH” in the attached reasoning: “7.4.1 – EC 221-343-4 – Acid Black 24 – Reasoning.pdf”
4. DATA MATRIX
See section 4. “DATA MATRIX” in the attached reasoning: “7.4.1 – EC 221-343-4 – Acid Black 24 – Reasoning.pdf”
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: data sharing dispute
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The room temperature varied between 21°C and 25°C during the study procedure.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed according to a generally accepted method.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS- Number of animlas: 30 males distributed as: 20 main test, 10 control group
6 males for the pre-test distributed as: 2 for intradermal test and 4 for epidermal
test - Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzer
land- Weight at study initiation: 306-377 g test group / 295-430 g Positive control group - Housing:
Individually in Makrol on type-3 cages with autoclaved standard softwood bedding ("Lignocel", Schill
AG, CH-4132 Muttenz)- Diet : Diet: Pelleted standard Kliba 342, Batch no. 63/94 guinea pig breedin
g/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum. Results of analy
ses for contaminants are included in this report.- Water: Community tap water from Fiillinsdorf, ad
libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water. Results of b
acteriological, chemical and contaminant analyses are included in this report.- Acclimation period:
One week for the control and test group under test conditions after health examination. No acclimati
zation for the animals of the pretest. Only animals without any visual signs of illness were used for
the study.Regular cleaning and disinfection of cages was performed to prevent contamination of pat
hogens according to standard operating procedure.ENVIRONMENTAL CONDITIONS- Temperature
(°C): 21° C - 25°C- Humidity (%): 52% -70%- Photoperiod: 12-hour light cycle- Music during the light
period - Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for intradermal injections and vaselinum alba for epidermal application
- Concentration / amount:
- For injections: 5 %,of the tested substance in water solution
For topic application: for induction peridod 50% of tested substance in vaseline alba, for the challenge 25 % of tested substance in vaseline alba - Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water for intradermal injections and vaselinum alba for epidermal application
- Concentration / amount:
- For injections: 5 %,of the tested substance in water solution
For topic application: for induction peridod 50% of tested substance in vaseline alba, for the challenge 25 % of tested substance in vaseline alba - Adequacy of challenge:
- not specified
- No. of animals per dose:
- Experimental group: 20 males Control group: 10 males
- Details on study design:
- A. INDUCTION: INTRADERMAL INJECTIONDay 1- treated group: An area of dorsal skin from the s
capular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections
(0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region as follows: i
njection 1: a 1:1 mixture Freunds Complete Adjuvant (FCA)/physiological saline injection 2:
5 % of the test substance in bi-distilled water solution injection 3: 5 % of the test substance
in water solution formulated in a 1:1 mixture FCA/waterDay 1- control group: Three paires
of intradermal injections of 0,1 ml volume were applied to the shaved area. injection 1: a 1:1
mixture FCA/physiological saline injection 2: bi-distilled water for injection injection
3: 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline. INDUCTION: TOPICAL APPLICATIONDay 8- treated group:
Tested area was again shaved on day 7. On the identical site of intradermal injection was applie
d a filter paper (2x4cm) which was loaded with 50% of tested substance in white vaseline
and held in contact by an occlusive dressing. The patch was covered with aluminum foil and
firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with
impervious adhesive tape. The dressings were left in place for approximately 48 hours. The epidermal
application procedure described ensured intensive contact of the test article. Day 8- control
group: Tested area was again shaved. White vaseline was applied to an
identical area of intradermal injection on filter paper (2x4 cm) in occlusive dressing for 48
hours. The gauze pad was kept in contact with the skin by an adhesive hypoalle rgenic patch
under an occlusive aluminum foil sheet. B. CHALLENGE: TOPICAL APPLICATIONDay 22- treated
and control group: On the right side of the animals was applied a filter paper (2x2 cm) impr
egnated with 25% solution of the tested substance in water for injections, occlusive dressing covered
a period of 24hrs. After 24 and 48 after the patch removal, the challenge area was cleaned
with water and was carried out clinical trials, focusing on the intensity of erythema and edema. - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol; 4-aminobenzoic acid ethyl ester
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in vaselinum album
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in vaselinum album. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in vaseline album
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in vaseline album. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + r eactions: 0.0. Total no. in groups: 10.0. Clinical observations: Erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + r eactions: 0.0. Total no. in groups: 10.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in vaseline album
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in vaseline album. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in vaseline album
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in vaseline album. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. No with. + r eactions: 0.0. Total no. in groups: 10.0. Clinical observations: Oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + r eactions: 0.0. Total no. in groups: 10.0. Clinical observations: Oedema.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The tested substance is a skin sensitizer.
- Executive summary:
In this study 40% of the animals were positive at the 24-hour reading and 25% at the 48-hour reading
after treatment with a non-irritant test substance concentration of 25% in vaselinum album.
The response of at least 30% positive animals is considered positive and the substance needs to be
classified as H317 following the Regulation (CE) 1272/2008.
Pathology - Necropsy: No necropsies were performed on the animals sacrificed at termination of the
observation period.
The animals were sacrificed with an intraperitoneal injection of NARCOREN (Rhone Merieux GmbH,
D-88471 Laupheim) at a dose of at least 5.1 ml/kg body weight (equivalent to 810 mg sodium
pentobarbitone/kg body weight) and discarded.
Clinical signs: No symptoms of systemic toxicity were observed in the animals.
Body weight: The body weight of the animals was within the normal range of variability. Three animals
of the test group and three of the epidermal pretest lost weight during the acclimatization period. They had recovered during the treatment
period.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
- Justification for non-LLNA method:
- Not reported
Test material
- Reference substance name:
- Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
- EC Number:
- 221-343-4
- EC Name:
- Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
- Cas Number:
- 3071-73-6
- Molecular formula:
- C36H25N5O6S2.2Na
- IUPAC Name:
- disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the available information and the reasoning explained above, it should be possible to infer that the target substance Acid Black 24 (EC: 221-343-4) is a skin sensitizer based on reliable data and no more experimental test is needed for the endpoint 7.4.1.
- Executive summary:
In conclusion, the target substance can be predicted to be a skin sensitizer. This substance has a molecular structure that is very similar to that of the source substance. The numerical similarity index between the target and the selected source is very high: 0.948 (in a range between 0 and 1).
In accordance with the scenario N°2 of the RAAF document [1] (different compounds having the same type of effects); on the basis of a reliable and robust read-across with the source substance Acid Blue 113 (EC: 222-111-5) it is possible to classify the target compound as a Skin Sensitizer with a good reliability.
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