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EC number: 274-393-4 | CAS number: 70209-96-0
- 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
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- Flash point
- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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:
- other: data on Acid Blue 225_constituent 1
- Adequacy of study:
- key study
- 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:
- The experiment was conducted on one of the substance components. It should be noted that the lot tested was characterized by the Acid Blue 225_constituent 1 as main component; however, the impurity profile (which includes also the Acid Blue 225_constituent 2) resulted to be similar to that characterizing the substance under assessment (details are given in the document attached to IUCLID section 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 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).
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Blue 225_constituent 1
- IUPAC Name:
- Acid Blue 225_constituent 1
Constituent 1
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 kg.
- Housing: in order to prevent injuries by bites, the rabbits were kept separately in V2A wire cages.
- Diet: food (NAFAG, Gossau SG, rabbit food), ad libitum.
- Water: ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and scarified
- Vehicle:
- other: 50 % polyethylene glycol trituration (PEG 400)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 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.
- Type of wrap if used: the patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
OBSERVATION TIME POINTS
24 and 72 hours.
SCORING SYSTEM
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.
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Remarks:
- both intact and scarified skin
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Remarks:
- both intact and scarified skin
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index of test item was 0.
Any other information on results incl. tables
Evaluation of the Skin Reactions
Animal No. Sex | Reaction | 24 hrs after application | 72 hrs after application | ||
Intact skin | Scarified skin | Intact skin | Scarified skin | ||
1 M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
2 M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
3 M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
4 F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
5 F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
6 F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non irritating
- Executive summary:
A study was performed to determine the skin irritation potential of test item on Russian breed rabbits according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
3 males and 3 females rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. The test item was applied to each side in quantities of 0.5 g; before application a 50 % polyethylene glycol trituration (PEG 400) was made.
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.
The primary irritation index, as the measure of the acute irritation to the skin of rabbits, was found to be 0; therefore test item resulted to be as non-irritant to the skin of rabbits.
Discussion and conclusion
The scoring system criteria used to record the severity of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008.
None of the animals showed any observable response to treatment throughout the 72 hours observation period, in both the cases of intact and scarified skin. Therefore, it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
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