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EC number: 239-311-3 | CAS number: 15267-95-5
- 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/corrosion (OECD 404): not irritating
Eye irritation (OECD 405): not 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:
- 09 August 2011 to 14 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit ud Lebensmittelsicherheit, Munich, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl: KBL (NZW)
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany (The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.)
- Age at study initiation: approximately 15 – 16 weeks
- Weight at study initiation: > 2kg
- Housing: in ABS - plastic rabbit cages, floor 4200 cm² (Semi barrier in an air-conditioned room)
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1415), rich in crude fibre, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 (recommendations of TVT [10], GV-SOLAS [11])
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: the residual test material was removed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed on the intact skin of the three female rabbits after a contact time of 4 hours.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed. The body weight was not affected by the test item application.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was tested for its skin irritating properties according to the OECD TG 404 and in compliance with GLP. No irritant effects were noted during the 72 h observation period following 4 h of exposure. No deaths occured, no signs of systemic toxicity were reported, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to EC/1272/2008 is not warranted.
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:
- 27 October 2011 to 14 November 2011
- 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:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: 2608.6–2795.9 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 35/11, Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 122201, imported by Indulab AG, Gams, Switzerland from ABEDD® - LAB & VET GmbH, 1160 Vienna, Austria) and a haystick 4642 (batch no. 06/11, Provimi Kliba AG, 4303 Kaiseraugst, Switzerland) were also provided for environmental enrichment.
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music played during the daytime light period.
IN-LIFE DATES: From 11 November 2011 to 14 November 2011 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- single application in to the left eye
- Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. )
- Details on study design:
- SCORING SYSTEM: Draize scoring system and according to Regulation (EC) 440-2008
TOOL USED TO ASSESS SCORE: hand-slit lamp (Varta Cliptrix diagnostic-lamp, Roth AG, 4153 Reinach, Switzerland) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: The maximum conjunctivae score for this animal was 1 at 1 and 24 h post treatment.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the measurement intervals. Slight redness of the conjunctivae was noted in one animal (no.3) at 1 and 24 hours after treatment. Thereafter, all animals were negative.The mean score was calculated separately for each animal across three scoring times (24, 48, and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 in two animals and 0.33 in one animal for reddening and all 0.00 for chemosis.
- Other effects:
- Viability/Mortality: No intercurrent deaths occurred during the course of the study.
Clinical signs: No clinical signs were recorded throughout the entire observation period.
Body weights: The body weights were within the range commonly recorded for this strain and age. - Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was tested for its eye irritating properties according to the OECD TG 405, and in compliance with GLP. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the measurement intervals. Slight redness of the conjunctivae was noted in one animal at 1 and 24 hours after treatment. Thereafter, all animals were negative. No deaths occured, no signs of systemic toxicity were repoted, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to EC/1272/2008 is not warranted.
Reference
see attachments
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
In the available key study (BSL BIOSERVICE, 2011a) the test item was tested for its skin irritating properties according to the OECD TG 404 and in compliance with GLP. 3 female New Zealand White rabbits were semiocclusively treated with 0.5 ml of the test material on the shaved dorsal area of the trunk for 4 hours. No irritant effects were noted during the 72 h observation period. No deaths occurred, and no signs of systemic toxicity were reported. Moreover, the body weight was not affected by the treatment. In conclusion, the test material was considered to be not irritating to the rabbits' skin under the conditions of the test.
Eye irritation:
In the available key study (Harlan, 2012c) the test item was investigated for eye irritation according to the OECD TG 405, and in compliance with GLP. The test item was applied by instillation of 0.1 ml into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours post treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the measurement intervals. Slight redness of the conjunctivae was noted in one animal at 1 and 24 hours after treatment. Thereafter, all animals were negative. The mean score was calculated separately for each animal across three scoring times (24, 48, and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.0 for all three animals. The individual mean scores for the conjunctivae were 0.0 in two animals and 0.33 in one animal for reddening and all 0.0 for chemosis. No deaths occurred, no signs of systemic toxicity were reported, and the body weight was not affected by the treatment. Hence, the test item was considered to be not irritating to the rabbits' eye under the conditions of the test.
Justification for classification or non-classification
The available data are reliable and suitable for classification. Based on these data classification for skin irritation and eye irritation according to EC/1272/2008 is not warranted.
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