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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
- 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 irritant to skin.
Irreversible eye damage.
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:
- From April 18th to 25th, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 17th, 1992
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- test substance was moistened with bi-distilled water before application.
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours after the removal of the dressing, guaze patch and test substance.
- Number of animals:
- 3 animals: 1 male, 2 females
- Details on study design:
- The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures.
To classify the irritating potential of the test article, the mean values of erythema/eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Commission Directive 93/21/EEC, April 27th, 1993). - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- COLORATION: blue to light blue staining by the test substance of the treated skin was observed.
CORROSION: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
MORTALITY: no mortality occured. - Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008).
- Conclusions:
- Not irritant to skìn.
- Executive summary:
The study procedures described in this report are based on the OECD Guideline 404 adopted July 17th, 1992.
Under the conditions of this experiment, the test item was found to cause blue to light blue staining of the treated skin.
No corrosion was observed at each of the measuring intervals.
Reference
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 April 25th to May 20th, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 24th, 1987
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg into one eye
- Duration of treatment / exposure:
- No rinsing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7, 14, 21 days after administration
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: no observation at 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 7 days. No corrosion was observed at any of the measuring intervals.
- Other effects:
- COLORATION: conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
MORTALITY/CLINICAL SIGNS: no mortality and no clinical signs were observed. - Interpretation of results:
- other: Eye Dam. 1 (H318), according to the CLP Regulation No (EC) 1272/2008
- Conclusions:
- Blue staining of the sclera and conjunctivae by the test article was observed in all animals. Conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
No corrosion was observed at any of the measuring intervals. - Executive summary:
The study procedures described in this report are based on the OECD Guideline 405 adopted February 24th, 1987.
Under the conditions of this experiment, the test item was found to cause blue staining of the sclera and conjunctivae.
Reversibility of any observed effect: changes fully reversible within 7 days.
No corrosion was observed at any of the measuring intervals..
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
The study procedures described in this report are based on the OECD Guideline 404 adopted July 17th, 1992.
Under the conditions of this experiment, the test item was found to cause blue to light blue staining of the treated skin.
No corrosion was observed at each of the measuring intervals.
The study procedures described in this report are based on the OECD Guideline 405 adopted February 24th, 1987.
Under the conditions of this experiment, the test item was found to cause blue staining of the sclera and conjunctivae.
Conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
Justification for classification or non-classification
Skin irritation
According to the CLP Regulation (EC) No. 1272/2008, Table: 3.2.2, Substances can be allocated in category 2 if the:
(1) Mean score of ≥ 2,3 and ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
For the substance under investigation the scores for erythema and oedema are always below the treshold for classification set out in the CLP Regulation, therefore the substance is not classified as skin irritant.
Eye irritation
According to the CLP Regulation (EC) No. 1272/2008, Table: 3.3.1, Substances can be allocated in category 1 if:
(a) in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or
(b) in at least 2 of 3 tested animals, a positive response of:
(i) corneal opacity ≥ 3; and/or
(ii) iritis > 1,5;
calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material.
For the substance under investigation, scleral staining persisted over 21 days. Therefore, the test substance is classified as Eye Dam. 1 according to the CLP Regulation (EC) No. 1272/2008.
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