Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 276-882-8 | CAS number: 72828-69-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- EC Number:
- 276-882-8
- EC Name:
- Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- Cas Number:
- 72828-69-4
- Molecular formula:
- C47H42N10O12S4.2Na
- IUPAC Name:
- disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- Details on test material:
- A yellow powder, labelled FAT 21015/A
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: New Zealand White
- Sex: male and female
- Age at study initiation (in days): 63 - 105 days
- Weight at study initiation: 2.60 kgs (males) and 2.58 kgs (females)
- Housing: Semi-barrier system
- Die: Styles-Oxoid commercial irradiated diet ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: 1 week
Animals:
Healthy New Zealand white rabbits (Porton strain) aged 9-15 weeks with average body weights of 2.60 Kgs. (M) and 2.58 Kgs. (F), bred on the premises and maintained under a semi-barrier system. Six rabbits (3M and 3F) were acclimatized in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (± 1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one side abraded and other side shaved only
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml; 0.75 ml of which was applied.
Dose: 0.5 g - Duration of treatment / exposure:
- After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h. The assessment of the macroscopic skin reaction was made according to the following grading system.
- Observation period:
- 72 h
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- Method:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 c.m. square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h. The assessment of the macroscopic skin reaction was made according to the following grading system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Individual Animal Score: Erythema
Animal Number |
Intact Skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
1 |
0 |
12 |
0 |
0 |
1 |
0 |
14 |
1 |
0 |
1 |
0 |
16 |
0 |
0 |
0 |
0 |
Individual Animal Score: Edema
Animal Number |
Intact Skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
1 |
0 |
2 |
1 |
13 |
1 |
0 |
1 |
0 |
15 |
1 |
0 |
2 |
0 |
12 |
3 |
0 |
3 |
1 |
14 |
1 |
0 |
2 |
1 |
16 |
3 |
0 |
3 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine skin irritation of FAT 21015/A in rabbits according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six animals with intact and abraded skin were used for this purpose. 10 g of the test compound was mixed uith 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad (conc:0.5 g). Slight erythema and very slight to moderate oedema were seen in 3/6 and 6/6 rabbits respectively 24 h after application of the compound. Very slight oedema was still present on 4/6 abraded sites only at 72 h. The primary irritation score was 1.3. However, the substance did not warrant classification according to the CLP (Regulation 1272/2008) criteria. Hence, FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.
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.