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EC number: 274-490-1 | CAS number: 70236-60-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Februaryfrom 1st to 4th, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines and performed according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact skin
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 rabbits
- Details on study design:
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
SCORING SYSTEM
Primary Irritation Index:
0: non-irritant
> 0 < 2: Mild irritant
> 2 < 5: Moderate irritant
> 5 < 8: Severe irritant - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 2.3
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 2.3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- Primary irritation index: 0.0
No evidence of skin irritation was noted. - Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating
- Executive summary:
Method
The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC) .
A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
Results and conclusion
Primary Irritation Index: 0.0
The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
Reference
Individual Skin Reactions Following 4-Hour Exposure Period
Skin Reaction | Observation time | Individual Scores - Rabbit Number and Sex | Total | ||
35 Male | 40 Male | 41 Male | |||
Erythema/Eschar formation | 1-h | 0 STA | 0 STA | 0 STA | 0 |
24-h | 0 STA | 0 STA | 0 STA | 0 | |
48-h | 0 STA | 0 STA | 0 STA | 0 | |
72-h | 0 STA | 0 STA | 0 STA | 0 | |
Oedema formation | 1-h | 0 | 0 | 0 | 0 |
24-h | 0 | 0 | 0 | 0 | |
48-h | 0 | 0 | 0 | 0 | |
72-h | 0 | 0 | 0 | 0 | |
Sum of 24 and 72 Hour Readings (S) | 0 | ||||
Primary Irritation Index (S/6) and Classification* | 0/6 = 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:
- February from 7th to 17th, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines and performed according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- A single application of 0.1 ml (51.3 mg) of the test material was administered to the non irrigated eye of three rabbits.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Ocular reactions were recorded 1,24,48 and 72 hours after administration.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 1
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- < 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Irritant / corrosive response data:
- The test material produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-hour observation.
Maximum Group Mean Score: 12.7. Mild irritant (Class 4 on A 1-8 scale) - Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating.
- Executive summary:
Method
The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09). The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).
A single application of 0.1 ml (51.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.
Results
The test material produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72 hour observation.
Maximum Group Mean Score: 12.7
Mild irritant (Class 4 on A 1-8 scale).
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 animals.
Therefore the substance does not meet the criteria to be classified as eye irritating.
In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).
Reference
Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex | 97 Male | 104 Male | 105 Male | ||||||||||||
IPR = 2 | IPR = 3 | IPR = 0+ | |||||||||||||
Time After Treatment |
1 hour | 24 hours | 48 hours | 72 hours | Mean 24, 48 and 72 hrs | 1 hour | 24 hours | 48 hours | 72 hours | Mean 24, 48 and 72 hrs | 1 hour | 24 hours | 48 hours | 72 hours | Mean 24, 48 and 72 hrs |
CORNEA |
|||||||||||||||
E = Degree of Opacity |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = Area of Cornea Involved | 0 | 0 | 0 | 0 | / | 0 | 0 | 0 | 0 | / | 0 | 0 | 0 | 0 | / |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
IRITIS | |||||||||||||||
D | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 0 | 0 | 0 | / | 5 | 0 | 0 | 0 | / | 5 | 0 | 0 | 0 | / |
CONJUNCTIVAE | |||||||||||||||
A = Redness | 1 Sf | 1 Sf | 1 Sf | 0 Sf | 0.7 | 2 Sf | 1 Sf | 1 Sf | 0 Sf | 0.7 | 1 Sf | 1 Sf | 1 Sf | 0 Sf | 0.7 |
B = Chemosis | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0.7 | 2 | 1 | 0 | 0 | 0.3 |
C = Discharge | 1 Re | 1Re | 0 | 0 | / | 2 Re | 1 Re | 1 Re | 0 | / | 2 | 1 | 1 | 0 | / |
Score (A + B + C) x 2 | 6 | 4 | 2 | 0 | 12 | 6 | 6 | 0 | 10 | 6 | 4 | 0 | |||
Total Score |
6 | 4 | 2 | 0 | 17 | 6 | 6 | 0 | 15 | 6 | 4 | 0 |
IPR = Initial pain reaction
+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
Sf = Black staining of the fur around the treated eye
Re = Black residual test material
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
Under the experimental conditions employed Acid Brown 282 (ABr282) did not induce skin irritation when applied to the rabbits skin.
EYE IRRITATION
The eye irritation potential of the ABr282 was assessed in tests conducted at different dye concentrations and ABr282 was judged as non irritating.
Two Huntsman's studies (Huntsman Textile Effects (Germany) GmbH, 1984 and 1974) were disregarded despite they were conducted according to internationally accepted testing procedures, because the substance concentration used was low and one of the impurity compounds of the lots tested is tetrahydro-furfurylalcohol (10.5 % and 11.9 %, respectively), which is classified according to the CLP Regulation, Annex VI, as eye irritant, category 2. Therefore, it is not known if the effects recorded should be attributed to the substance itself or if they are determined by the presence of tetrahydro-furfurylalcohol. Furthermore, another relevant aspect, that may be determinant in the assessment, is that it is not known if the solid substance tested was removed within 1 hours after application; in fact, the test guideline version followed (OECD 405, 1981) in the current test did not envisage the removal of the substance within 1 hours, therefore, it cannot be excluded that the irritation potential determined by the powder form may contributed to the reactions observed. In conclusion, the study has been disregarded.
Justification for selection of skin irritation / corrosion endpoint:
Study conducted according to internationally accepted testing guidelines and performed according to GLP.
Justification for selection of eye irritation endpoint:
Study conducted according to internationally accepted testing guidelines and performed according to GLP.
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.
In the key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
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 animals in the key study.
In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).
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