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EC number: 276-123-0 | CAS number: 71873-46-6
- 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
Endpoint summary
Administrative data
Description of key information
Not skin irritating
Not eye irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From May 26th to August 15th, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The read across approach is detailed into the document attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Association of Breeders of Hradec Kralove.
- Weight at study initiation: above 2.5 kg.
- Housing: the rabbits were house invidually in metal cages commercially produced without bedding, with automatic air-condition.
- Diet: rabbits were fed standard commercially manufacturing feed mixture TM-rabbit, ad libitum.
- Water: drinking water according to CSN 757111 ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod:12 hrs cycle dark /light
- Other: fluorescent light - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: an area of 6 cm × 6 cm was depilated. For the formation of scarified skin, four horizontal and four vertical incisions were made. Depilated area of skin outside of the application zone was used to control the assessment.
- Type of wrap if used: the sample was covered with gauze, above which aluminum film and cellulose wadding was applied. Technical tape was used so that the test substance was in contact with the depilated skin.
SCORING SYSTEM
The degree of erythema was diagnosed visually, and the degree of edema was assessed by visual examination and palpation, accordign to the OECD guideline 404. - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean erythema and edema score for the three rabbits is 0.
At 4, 24, 48 and 72 hours after removal of patch no rmacroscopic or pathomorphological changes were identified on the intact or scarified skin. The present sample after epicutaneous application to the skin of rabbits did not induce contact dermatitis. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC1272/2008)
- Conclusions:
- Not irritant.
- Executive summary:
The substance was evaluated for skin irritation/ corossion, according to OECD guideline 404. The test substance (0.5 g) was applied as a paste on the intact (left lateral depilated area) and scarified skin (right lateral depilated area) of three New Zealand white rabbits. Depilated area of skin outside the application zone was used to control the assessment.
After 4, 24, 48 and 72 hours of the removal of the patch the animals were examined for signs of erythema and ethema. No edema or erythema signs were identified on the intact skin and neither on the scarified skin.
Based on erythema and edema scores, the test substance is not considered to be irritating to the skin.
Conclusion
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 1272/2008).
Reference
Animal No | Reaction | Intact skin | Scarified skin | ||||||
4 hrs | 24 hrs | 48 hrs | 72 hrs | 4 hrs | 24 hrs | 48 hrs | 72 hrs | ||
14 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
29 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
30 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 24th to March 06th, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland.
- Age at study initiation: 14 - 15 weeks.
- Weight at study initiation: 2.4 - 2.5 kg.
- Housing: individually in steinless steel cage, equipped with automatic cleaning and drinking system.
- Diet: pelleted standard Kilba 341, batch 93/83, rabbit maintenance diet, ad libitum.
- Water: community tap water, ad libitum.
- Acclimation period: 4 days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10 - 15 air change per hour.
- Photoperiod: 12 hrs artificial light / hrs darkness.
- Other: at least 8 hours of music / light period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g per animal
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 maes and 2 females
- Details on study design:
- TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL and a Varta Cliptrix diagnostic-lamp.
OBSERVATIONS
- Viability/mortality: daily
- Body weight: pre-treatment, day 1 and at termination of the test.
SCORING SYSTEM
The rabbits were examined 1, 24, 48, 72 hours and 7 days after application of the test compound. The ocular reactions were scored according to the OECD guideline 405.
Opacity-degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse area (other than slight dulling of normal luster) details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacros area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
Conjunctivae Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis: lids and/or nictating membranes
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4 - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Test substance showed a primary irritation score of 2.1 when applied to the rabbits eye mucosa.
In the area of application a bluish discoloration of the cornea, sclera and conjunctivae was observed within 1 hour after treatrnent. This could be related to effects of the test article
No corrosion of the cornea was observed at each of the measuring intervals..
TOXIC SYMPTOMS / MORTALITY
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.
BODY WEIGHT
The body weight gain of all rabbits was similar. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not irritating
- Executive summary:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405. A single application 0.1 g of the test material was administered to the eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.
Test substance showed a primary irritation score of 2.1 when applied to the rabbits eye mucosa. In the area of application a bluish discoloration of the cornea, sclera and conjunctivae was observed within 1 hour after treatrnent. This could be related to effects of the test article. No corrosion of the cornea was observed at each of the measuring intervals.
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred. The body weight gain of all rabbits was similar.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of three tested animals. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Eye irritation scores
Animal N / sex | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24/48/72 hrs |
281 M | Cornea opacity | 0 | 1* | 1* | 0 | 0 | 0.67 |
282 F | Cornea opacity | 0 | 1* | 1* | 0 | 0 | 0.67 |
283 F | Cornea opacity | 1* | 1* | 1* | 0 | 0 | 0.67 |
281 M | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
282 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
283 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
281 M | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
282 F | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
283 F | Conjunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
281 M | Conjunctivae chemosis | 2* | 1 | 0 | 0 | 0 | 0.33 |
282 F | Conjunctivae chemosis | 2* | 2* | 0 | 0 | 0 | 0.67 |
283 F | Conjunctivae chemosis | 2* | 1 | 0 | 0 | 0 | 0.33 |
Primary irritation score
Time point | Mean scores |
1 hr | 2.3 |
24 hrs | 3.3 |
48 hrs | 2.0 |
72 hrs | 1.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
No information on the skin irritation/corrosion potential of the Target Substance is available. For this reason data coming from an analogue substance (Similar Substance 01) has been taken into account. More details aboit the similarity between the two substances is reported in the document attached in section 13.
The substance was evaluated for skin irritation/ corrosion, according to OECD guideline 404. The test substance (0.5 g) was applied as a paste on the intact (left lateral depilated area) and scarified skin (right lateral depilated area) of three New Zealand white rabbits. After 4, 24, 48 and 72 hours of the removal of the patch the animals were examined for signs of erythema and ethema; no edema or erythema signs were identified on the intact skin and neither on the scarified skin.
Based on erythema and edema scores, the test substance is not considered to be irritating to the skin.
EYE IRRITATION
A study was performed to assess the eye irritation potential of Acid Blue 278 to New Zealand White rabbit. The method followed OECD Guidelines No. 405. A single application 0.1 g of the test material was administered to the eye of three rabbits. Th eyes were not rinsed. Test substance showed a primary irritation score of 2.1 when applied to the rabbits eye mucosa. In the area of application a bluish discoloration of the cornea, sclera and conjunctivae was observed within 1 hour after treatrnent. No corrosion of the cornea was observed at each of the measuring intervals. No acute toxic symptoms were observed in the animals during the test period and no mortality occurred. The body weight gain of all rabbits was similar.
In addition, a sheet reporting the test results of an old experiment conducted on Acid Blue 278 is available. The effects were scored in accordance to the ETAD system. However, due to the fact that details on testing procedures and results are lacking, a reliability cannot be assiged. The result is here mentioned for completeness sake. The substance was indicated to be slightly irritating (Sheet of test results, 1977).
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
On the basis of the available information, the substance was not classified.
According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals. In addition, all the recorded effects were fully reversible within 72 hours.
In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.
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