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EC number: 941-899-8 | CAS number: -
- 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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Poods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- yes
- Remarks:
- occlusive testing conditions, abraded testing conditions used
- Principles of method if other than guideline:
- Guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate
- EC Number:
- 941-899-8
- Cas Number:
- 1625603-53-3
- Molecular formula:
- C29H18Br2N5Na3O13S3 . C29H19Br3N5Na3O13S3
- IUPAC Name:
- Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate
- Test material form:
- other: solid
Constituent 1
- Specific details on test material used for the study:
- None
Test animals
- Species:
- rabbit
- Strain:
- other: Russian breed,
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs,
- Housing: kept separately in V2A wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hr
- Observation period:
- 72 hr
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: gauze patch size was 2.5 x 2.5 cm
- Type of wrap if used: patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 24 hr
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- No effects observed
- Remarks on result:
- other: animal 4 & 5 showed edima score 1 on sacrified skin. The effects were full reversable at the end of 72 hr
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritant / corrosive response data:
- All animals except animal #4 and #5 showed no effects. Animal 4 & 5 showed edema score 1 on sacrified skin. The effects were fully reversible after 72 hrs. The primary irritation index of FAT 40065/A was 0.1.
- Other effects:
- None
Any other information on results incl. tables
Table 1: Skin irritation – individual scores
Animal No. |
Sex |
Skin reaction |
2 4 h after application |
72 h after application |
||
intact skin |
scarified skin |
intact skin |
scarified skin |
|||
1 |
female |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
||
2 |
female |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
||
3 |
female |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
||
4 |
male |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
1 |
0 |
0 |
||
5 |
male |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
1 |
0 |
0 |
||
6 |
male |
erythema |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40065/A is considered to be not a skin irritant.
- Executive summary:
The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by test substance FAT 40065/A on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
FAT 40065/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it.
The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.1. Rabbit # 4 and 5 had only observation of edema scored as 1 at 24 h observation, which was found to reverse at 72 h observation. No other findings were recorded. Hence, the scoring does not meet the threshold scores for classification as proposed by Regulation EC No. 1272/2008. Hence, FAT 40065/A is considered to be not a skin irritant.
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