Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 440-870-2 | CAS number: 1013-88-3
- 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
The test substance is irritating to the skin of rabbits (OECD TG 404, GLP).
The test substance is mildly irritating to the eyes of rabbits (OECD TG 405, GLP).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
- Stability under test conditions: proven by reanalysis - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet : Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5 ml unchanged liquid test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece, Baiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: mild detergent (lutrol, lutor/water (1:1))
- Time after start of exposure: 4 hours
SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION VALUE
0: NO ERYTHEMA
1: VERY SLIGHT ERYTHEMA (BARELY PERCEPTIBLE)
2: WELL DEFINED ERYTHEMA
3: MODERATE TO SEVERE ERYTHEMA
4: SEVERE ERYTHEMA (BEET REDNESS) TO ESCHAR FORMATION PREVENTING GRADING OF ERYTHEMA
EDEMA FORMATION VALUE
0: NO EDEMA
1: VERY SLIGHT EDEMA (BARELY PERCEPTIBLE)
2: SLIGHT EDEMA (EDGES OF AREA WELL DEFINED BY DEFINITE RAISING)
3: MODERATE EDEMA (RAISED APPROX. 1 MM)
4: SEVERE EDEMA (RAISED MORE THAN 1 MM AND EXTENDING BEYOND AREA OF EXPOSURE) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritant / corrosive response data:
- The average score (24 - 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Intensive scaling was observed on day 8 and day 14. No necrosis was observed
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
- Executive summary:
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of three white New Zealand rabbits for 4 hours under semi-occlusive dressing. The study was conducted according to OECD TG 404 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
Reference
Table 1: IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME:
Reading | Animal | Erythema | Edema |
1 hour | 1 | 3 | 3 |
2 | 3 | 3 | |
3 | 3 | 3 | |
24 hours | 1 | 4 | 3 |
2 | 4 | 3 | |
3 | 4 | 4 | |
48 hours | 1 | 4 | 2 |
2 | 3 | 1 | |
3 | 3 | 2 | |
72 hours | 1 | 4 | 2 |
2 | 2 | 1 | |
3 | 3 | 2 | |
8 days | 1 | 3 | 0 |
2 | 2 | 1 | |
3 | 2 | 1 | |
15 days | 1 | 2 | 0 |
2 | 2 | 1 | |
3 | 2 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
- Stability under test conditions: proven by reanalysis - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet : Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
- Washing: washed out with water
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Cornea*: opacity (op): Degree of density (area most dense taken for reading)
0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, na details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.
Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼ ; < ½
3 ≥ ½; < ¾
4 ≥ ¾
Conjunctivae*: redness (red): (Refers to palpebral and bulbar conjunctivae, cornea and iris)
0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible.
3 = Diffuse beefy red.
Chemosis (sw): Lids and/or nictating membranes (sw)
0 = No swelling.
1 = Any swelling above normal (includes nictating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye
Iris:*
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circunicorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, haemorrhage, gross destruction (any or all of these).
Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 =Discharge with moistening of lids.
3 =Discharge with moistening of the lids and hairs, and considerable area around the eye
* Table according to OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- The average score (24 - 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. See table 1.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.
- Executive summary:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in three white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0. The study was conducted according OECD TG 405 and GLP.
The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Symptoms observed and described in the respective obdervation table in detail together with the average score for irritation do not indicate an irritant property of the test substance to the eye.
Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.
Reference
Table 1: IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME:
Reading | Animal # | Cornea Opacity | Iris | Conjunctivae Erythema | Chemosis |
1 hour | 1 | 0 | 0 | 1 | 2 |
2 | 0 | 0 | 2 | 2 | |
3 | 0 | 0 | 2 | 1 | |
24 hours | 1 | 1 | 1 | 3 | 1 |
2 | 1 | 1 | 3 | 2 | |
3 | 1 | 0 | 2 | 2 | |
48 hours | 1 | 1 | 0 | 2 | 0 |
2 | 1 | 1 | 3 | 2 | |
3 | 1 | 1 | 2 | 1 | |
72 hours | 1 | 1 | 0 | 1 | 0 |
2 | 1 | 1 | 2 | 1 | |
3 | 1 | 1 | 2 | 1 | |
8 days | 1 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of three white New Zealand rabbits for 4 hours under semi-occlusive dressing. The study was conducted according to OECD TG 404 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
Eye irritation
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in three white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0. The study was conducted according OECD TG 405 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Symptoms observed and described in the respective obdervation table in detail together with the average score for irritation do not indicate an irritant property of the test substance to the eye. Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.
The test substance was irritating to the skin of rabbits in a study according OECD TG 404 and GLP and mildly irritating to the eyes of rabbits ina a GLP-compliant OECD TG 405 study. Therefore, the test is classified for skin irritation Cat. 2 and eye irritation Cat. 2 under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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.