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EC number: 235-628-6 | CAS number: 12392-64-2
- 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, In vivo, Rabbit : not irritating (Dystar, 1994)
in vitro skin irritation data not available
Eye, In vivo, Rabbit : H319 Category 2A (Dystar 1994)
in vitro eye irritation data not available
Respiratory system: no information available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo test. At the time of testing in-vitro test were not available
- 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: Study following official guidelines, GLP compliant, performed on a similar substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.- Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: the controlateral skin area not treated with test substance served as control
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h, 7d, 14d
- Number of animals:
- 3
- Details on study design:
- Approx. 24hours before the test fur was shaved from the dorso-lateral area of the trunk (6x6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used. 500 mg of the pulverised test substance were moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed in the opposite dorso-lateral areas of the trunk of each animal and were held in place with semiocclusive dressing for the duration of the exposure period. After the exposure time the dressing was removed and the exposed skin areas were carefully washed with water withou altering the existing response or the integrity of the epidermis.SCORING SYSTEM: for each animal the Draize scores recorded at 24, 48 and 72 h were added up. The total was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.TOOL USED TO ASSESS SCORE:fluorescein
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The substance was tested for skin irritation following OECD 404 and resulted not to have irritant potential to the skin.
- Executive summary:
The irritant/corrosive potential of the test substance was studied on the skin of rabbit in accordance with the OECD Guideline 404 for Testing of Chemicals.
Evaluation of erythema was not possible in all three animals due to the intense colouration by the test substance. Neverthless no other inflammatory signs (oedema or eschar formation) became apparent within the obervation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as "not irritating" to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo test. At the time of testing in-vitro test were not available
- 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: Study following official guidelines, GLP compliant, performed on a similar substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions. - Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- pulverized
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100ul (ca. 34 mg)
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 7d, 14d, 21d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PROCEDURE:After gently pulling the lower lid away from the eyeball a volume of 100ul of the pulverised test substance-equivalent to approx. 34 mg- was placed into the conjunctival sac of one eye of each of three rabbits. The lids were than getnly held together for about on second in oirder to limit loss of the material. The other eye remained untreated and served as contro.l 24 hours after instillation of the test substance the treated eye was rinsed with normale saline.SCORING SYSTEM: for each animal the Draize scores (cornea, iris, conjunctivae, erythema and swelling and discharge) and the Mcdonald score (aqueous humor) were used. For each animal the Draize scores recorded approx. 24, 48 and 72h after application were added up. The total of these three values was divided by 3 to give the irritation index.TOOL USED TO ASSESS SCORE:optical instrument (hand slit lamp) and fluorescin.Only effects persisting for more than 24 hours were included in the evaluation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The substance was tested for eye irritation following OECD 405 and resulted to be irritant to the eye with classification H319 Category 2A.
- Executive summary:
The irritant/corrosive potential of the test substance was studied on the eye of rabbit in accordance with the OECD Guideline 405 for Testing of Chemicals. Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea in all three animals. Additionally in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The potential of the test substance to cause acute dermal irritation or corrosion was assessed in vivo in rabbits according to OECD 405. In this study the test article did not show any irritative/corrosive potential by a semi-occlusive application of the test substance to the skin of 3 rabbits for 4 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for edema. It was not possible to assess erythema due to discoloration of the skin
Eye
The potential of the test substance to cause eye irritation or corrosion was assessed in 3 rabbits following OECD 404. The test substance was assesed to be eye irritant with a final classification H319 Category 2 due to conjunctivae score equal to 2 for all the 3 animals.
Respiratory system
No data available
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:
Skin irritant cat2:
1) Mean value of ≥ 2,3 - ≤ 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; o
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.
based on the results of the in vivo skin irritation test the substance is not classified as skin irritant
Eye irritant Cat 2:
at least in 2 of 3 tested animals, a positive response of:
1) corneal opacity ≥ 1 and/or
2) 2) iritis ≥ 1, and/or
3) conjunctival redness ≥ 2 and/or
4) conjunctival oedema (chemosis) ≥ 2
5) 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
Based on the results of the conjuncitva score the substance is classified as H319 Category 2
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