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EC number: 269-304-0 | CAS number: 68214-62-0
- 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
- 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
Non skin irritating
Non 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.9 kg.
- Housing: individually in stainless steel cages equipped with a automatic cleaning and drinking system.
- Diet: pelleted standand KIiba 341, Batch 94/84 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, Switzerland), ad libitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: four days under Iaboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 air changes per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.
- Other: at least 8 hours music/light period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single dose was administrated to the left eye of each animal. The individual dose volume was 0.1 g per animal.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.
OBSERVATIONS
- Viability/mortality: daily.
- Body weight: pre-test, day 1 and at termination of test on Mettler PK 16 balance.
SCORING SYSTEM
The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. The irritation was assessed according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 48 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: 72 hrs
- Irritant / corrosive response data:
- Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa.
In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article.
No corrosion was observed at each of the measuring intervals. - Other effects:
- TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animlas 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 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Three rabbits were used to test the eye irritation potential of the substance, in accordance with OECD guideline 405. 0.1 g of the undiluted test material were placed into the conjunctival sac. The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. Reading scores for ocular lesions were made according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
Under the conditions of the experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa. In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
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 chemosis, in all the tested animals. All the reactions were fully reversible.
Thus, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June from 01st to 04th, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.8 kg.
- Housing: individually in stainless steel cages equipped with a automatic cleaning and drinking system.
- Diet: pelleted standand KIiba 341, Batch 25/87 and 26/87 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, Switzerland), ad libitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: five days under Iaboratory conditions, after veterinary examination. The eyes of the animals were observed 24 hours prior to test article administration.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 40 - 70 %
- Air changes: 10 - 15 air changes per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.
- Other: music/light period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single dose was administrated to the left eye of each animal. The individual dose volume was 0.1 g per animal.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.
OBSERVATIONS
- Viability/mortality: daily.
- Body weight: pre-test, day 1 and at termination of test on Mettler PK 16 balance.
SCORING SYSTEM
The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. The irritation was assessed according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded. - 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: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- Under the conditions of the experiment, the test item was found to cause a primary irritation score of 1.9 when applied to the rabbit eye mucosa.
Corneal opacity was observed in two animals duning the test. Anlmal no. 458 (male) showed sllght opacity from 1 to 48 hours, anirnal no. 459 (female) showed diffuse opacity from 1 to 24 hours after test article application. - Other effects:
- TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animlas 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 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Three rabbits were used to test the eye irritation potential of the substance, in accordance with OECD guideline 405. 0.1 g of the undiluted test material were placed into the conjunctival sac. The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration. Reading scores for ocular lesions were made according to the OECD guideline for testing of Chemicals, Section 4, number 405 "Acute Eye Irritation/Corrosion" adopted May 12, 1981.
Under the conditions of the experiment, the test item was found to cause a primary irritation score of 1.9 when applied to the rabbit eye mucosa.
Corneal opacity was observed in two animals duning the test. Anlmal no. 458 (male) showed sllght opacity from 1 to 48 hours, anirnal no. 459 (female) showed diffuse opacity from 1 to 24 hours after test article application.
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 chemosis, in all the tested animals. All the reactions were fully reversible within 72 hours.
Thus, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).
Referenceopen allclose all
Eye irritation score
Animal N. | Reaction | After | Mean 24/48/72 hrs | ||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | |||
320 M | Cornea opacity | 1 | 1 | 0 | 0 | 0 | 0.33 |
321 F | Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
322 F | Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
320 M | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
321 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
322 F | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
320 M | Conjuntivae redness | 1 | 2 | 2 | 1 | 0 | 1.67 |
321 F | Conjuntivae redness | 1 | 1 | 1 | 1 | 0 | 1.00 |
322 F | Conjuntivae redness | 1 | 1 | 1 | 1 | 0 | 1.00 |
320 M | Conjunctivae chemosis | 2 | 2 | 1 | 0 | 0 | 1.00 |
321 F | Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0.33 |
322 F | Conjunctivae chemosis | 2 | 1 | 0 | 0 | 0 | 0.33 |
Eye irritation score
Animal N. | Reaction | After | Mean 24/48/72 hrs | |||
1 hr | 24 hrs | 48 hrs | 72 hrs | |||
457 M | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
458 M | Cornea opacity | 1 | 1 | 1 | 0 | 0.67 |
459 F | Cornea opacity | 1 | 1 | 0 | 0 | 0.33 |
457 M | Iris | 0 | 0 | 0 | 0 | 0.00 |
458 M | Iris | 0 | 0 | 0 | 0 | 0.00 |
459 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
457 M | Conjuntivae redness | 1 | 1 | 1 | 0 | 0.67 |
458 M | Conjuntivae redness | 1 | 1 | 1 | 0 | 0.67 |
459 F | Conjuntivae redness | 1 | 1 | 1 | 0 | 0.67 |
457 M | Conjunctivae chemosis | 1 | 0 | 0 | 0 | 0.00 |
458 M | Conjunctivae chemosis | 2 | 2 | 1 | 0 | 1.00 |
459 F | Conjunctivae chemosis | 1 | 1 | 0 | 0 | 0.33 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
An old experiment was conducted on the test item; however, due to the fact that details on testing procedures and results are lacking, a reliability cannot be assigned. The result is here mentioned for completeness sake. The skin irritation potential was assayed in rabbits and scored according to the U.S. Hazardous Substance Act of 16.09.1964.. The substance was indicated to be non skin irritating (see attachment).
In order to assess the skin irritation potential of Acid Blue 280, the available information on the structural analogue Similar Substance 03 was taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID 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
An old experiment was conducted on the test item; however, due to the fact that details on testing procedures and results are lacking, a reliability cannot be assigned. The result is here mentioned for completeness sake. The eye irritation potential was assayed in rabbits and scored according to the U.S. Hazardous Substance Act of 16.09.1964.. The substance was indicated to be non eye irritating (see attachment).
In order to clarify the eye irritation potential of Acid Blue 280, the available information on the structural analogues Similar Substance 02 was taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).
Two different experiments are available; in both the cases, Similar Substance 02 was tested in accordance with OECD guideline 405 and 0.1 g of the undiluted test material were placed into the conjunctival sac.
Under the conditions of the first experiment, the test item was found to cause a primary irritation score of 1.9 when applied to the rabbit eye mucosa. Corneal opacity was observed in two animals duning the test. Animal no. 458 (male) showed sllght opacity from 1 to 48 hours, anirnal no. 459 (female) showed diffuse opacity from 1 to 24 hours after test article application.
In the second experiment, the test item was found to cause a primary irritation score of 2.2 when applied to the rabbit eye mucosa. In the area of application a bluish dicoloration of the conjunctivae was observed within 1 hour after treatment; this could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
In both the experiments, 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 chemosis, in all the tested animals. All the reactions were fully reversible within 72 hours.
REFERENCE
See attachment
Justification for classification or non-classification
According to the CLP Regulation (EC 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.
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.
According to the CLP Regulation (EC 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. Eye irritation means the production of changes in the eye, which are 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 chemosis, in all the tested animals. All the reactions were fully reversible within 72 hours.
In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).
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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.