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EC number: 282-617-7 | CAS number: 84281-74-3
- 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
skin irritation (rabbit, occlusive, intact and abraded skin BASF 1979): not irritant
eye irritation (rabbit, powder, BASF, 1979): classified as H318: causes serious eye damage
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.41
- Principles of method if other than guideline:
- The hair was removed from the lateral skin over an area of about 8 x 8 cm on both sides of the trunks of 6 rabbits with an average weight of 2.3 kg using electric clippers 24 hours before the beginning of the study. The skin on the right flank was also abraded by means of a scarifier at the site where the test patch was to be applied. Patches (2.5 x 2.5 cm) of double layers of surgical gauze were coated/impregnated with 500 mg of the test substance made into a paste with water and covered with indifferent impermeable PVC film (5 x 5 cm). The film with the patch underneath was attached to the two test sites by means of adhesive tape (Leukoflex R ) that does not irritate the skin. The whole trunk of the animals was then bandaged with an elastic fixed bandage (Elastoflex R ) for the duration of the exposure period of 24 h. The animals were restrained.Findings were reported immediately (about 30 min) after the removal of the patches (24-h value) and then 48 h and 72 h after the beginning of the study (48 h after the first reading).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, F.R.G.- Housing: animals were housed in single cages.- Diet: "muemmel z" feed (sniff, Soest F.R.G.) ad libitum- Water: ad libitum- Acclimation period: 4-6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 500 mg
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: Leukoflex, ElastoflexSCORING SYSTEM: Erythema and eschar formation: Value- 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): 4Edema formation- No edema: 0- Very slight edema (barely perceptible): 1- Slight edema (edges of area weil defined by definite raising): 2- Moderate edema (raised approximately 1 mm): 3- Severe edema (raised more than 1 mm and extending beyond the area of exposure): 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test substance. Staining persisted until study end (8 days).
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: The 48-h value does not appear on the report sheet.
- Interpretation of results:
- other: Not classified under Regulation 1272/2008
- Conclusions:
- The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.
- Executive summary:
The analogue substance 1 was tested for skin irritation following Code of Federal Regulations, Title 16, Section 1500.41 . Under the experimental conditions the substance does not show any skin irritation potential.
Reference
Reading and exact calculation of the erythema index not possible because of staining of the skin caused by the test.
Mean edema score:
Animal No. | 24h | 72h | 8 days | mean 24 -72 h | mean score all animals (24 - 72 h) | |||||
intact skin | 1 | 0 | 0 | 0 | 0 | |||||
2 | 1 | 1 | 2 | 1 | ||||||
3 | 0 | 0 | 0 | 0 | ||||||
4 | 0 | 3 | 0 | 1.5 | ||||||
5 | 1 | 2 | 2 | 1.5 | ||||||
6 | 0 | 2 | 0 | 1 | ||||||
0.83 | ||||||||||
abraded skin | 1 | 1 | 0 | 0 | 0.5 | |||||
2 | 1 | 2 | 2 | 1.5 | ||||||
3 | 1 | 1 | 0 | 1 | ||||||
4 | 1 | 3 | 1 | 2 | ||||||
5 | 1 | 2 | 2 | 1.5 | ||||||
6 | 0 | 0 | 0 | 0 | ||||||
1.083 |
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:
- migrated 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:
- other: Guideline study with acceptable restrictions performed on analogue substance 1
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Principles of method if other than guideline:
- The test was carried out by applying 100 µl bulk volume of the crystalline substance to the conjunctival sac of the lower right eyelid of rabbits that had been previously examined and had a mean weight of 2.3 kg. The lids were then gently held together for 1 sec. The eye was not washed after the application. The second, left eye of the rabbits always remained untreated as the control. The assessment was made with the aid of an ophthalmoscope.Cornea findings were verified after 8 days using the fluorescein test (instillation of 1 drop of fluorescein solution in an ophthalmological formulation directly onto the cornea. After washing with physiological saline solution corneal lesions appear yellow-green, UV light or cobalt blue-filter).Findings were obtained 24, 48 and 72 h and 8 days after the beginning of the study.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Versuchstierzuchten W. Ostrop, Meerbusch, FRG- Weight at study initiation: 2.3 kg- Housing: animais were housed in single cages- Diet: "muemmel z" feed (ssniff, Soest, FRG) ad libitum.- Water: ad libitum- Acclimation period: 4-6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 16-18 °C- Humidity (%): 40%
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 100 µl
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: classified under Regulation 1272/2008 H318, Eye Damage 1
- Conclusions:
- The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage (iris score > 1.5 for 4 animals out of 6).
- Executive summary:
The analogue substance 1 was tested for eye irritation following Code of Federal Regulations, Title 16, Section 1500.42 . Based on the iris average indexes at 24, 48 and 72h, under the experimental conditions and following critieria set by Regulation 1272/2008 the substance is classified as Eye Damage 1, H318: Causes serious eye damage.
Reference
24h | 48h | 72h | 8 days | |||||||||||||||||||||
Animal No. | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 |
Cornea |
||||||||||||||||||||||||
A) Opacity | 3 | 3 | 2 | 1 | 1 | 1 | 3 | 2 | 2 | 1 | 2 | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 1 |
B)Area | 4 | 4 | 4 | 1 | 1 | 3 | 3 | 2 | 2 | 1 | 3 | 2 | 3 | 1 | 1 | 1 | 1 | 1 | 4 | 1 | 1 | 1 | 1 | 1 |
a=A*B*5 | 60 | 60 | 40 | 5 | 5 | 15 | 45 | 20 | 20 | 5 | 30 | 10 | 15 | 10 | 10 | 10 | 10 | 5 | ||||||
Iris |
2 | 2 | 2 | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
b=A*5 | 10 | 10 | 10 | 5 | 5 | 10 | 10 | 10 | 10 | 5 | 5 | 10 | 10 | 10 | 10 | 5 | 5 | 10 | ||||||
Conjunctivae |
||||||||||||||||||||||||
A) Redness | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 1 | 2 | 1 | 1 | 3 |
B) Swelling | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 2 | 2 | 2 | 4 | 4 | 3 | 2 | 3 | 2 | 3 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
C) Discharge | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 0 | 1 | 1 | 1 | 2 |
c=(A+B+C)*2 | 20 | 20 | 18 | 20 | 20 | 20 | 20 | 14 | 14 | 14 | 20 | 20 | 16 | 14 | 14 | 14 | 16 | 16 | ||||||
total= a+b+c(max. 110) | 90 | 90 | 68 | 30 | 30 | 45 | 75 | 44 | 44 | 24 | 55 | 40 | 41 | 34 | 34 | 29 | 31 | 31 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two in vivo studies are available for the assessment of irritation/corrosion potential of the analogue substance 1 to the skin and the eye.
The intact and abraded skin of New Zeakand rabbits were exposed to the substance in an occlusive way without showing any irritation effect (only oedema could be assessed and not erythema due to the staining of the skin by the dye substance).
The eye irritation potential was tested with powdered form of the substance on New Zealand rabbits showing a mean value (24,48 and 72h) of the iris score equal to 2 for 4 animals out of 6, which classifies the substance as H318: serious eye damage.
based on the read across considerations the same classification for eye irritation potential is applied to Basic Brown 1 acetate.
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on provided data the substance is classified as H318: Causes serious eye damage, Eye Damage 1 under the Regulation 1272/2008.
Based on the provided data the substance is not classified for skin irritation
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