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EC number: 945-889-4 | CAS number: -
- 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: The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.
EYE : The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
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:
- 25 August 2015 - 01 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS Ltd, Leicestershire UK.
- At the start of the study the animals weighed 2.56 to 2.76 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days, each animal was given a unique number within the study by writing with black indelible marker-pen on the inner surface of the ear and on the cage label.
- Animals were individually housed in suspended cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS Ltd, Oxon, UK) was allowed throughout the study.
- The diet and drinking water were considered not contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and elative humidity were set to achieve limits of 17 °C to 23 °C and 30 % to 70 % respectively.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
- The animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g of test item
- Duration of treatment / exposure:
- Four hours
- Observation period:
- Seven days
- Number of animals:
- Two
- Details on study design:
- TEST ITEM FORMULATION
- The test item was used as supplied
- The absorption of the test item was not determined. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Individual scores and mean scores for erythema/eschar and edema are given in Table 1 (attached).
- Very slight erythema and very slight edema were noted at both treated skin sites immediately after patch removal.
- Very slight erythema with or without very slight edema were noted at both treated skin sites at the 1 hour after patch removal and at 24, 48 and 72-hour observations.
- Treated skin sites appeared normal at the 7-day observation. - Other effects:
- - Individual body weights and body weight changes are given in Table 2 (attached).
- Both animals showed expected gain in body weight during the study. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.
- Executive summary:
INTRODUCTION
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B.4 Acute Toxicity (Skin Irritation).
RESULTS
A single 4 -hour, semi-occluded application of the test item to the intact skin of two rabbits produced very slight erythema and very slight edema. Both treated skin sites appeared normal at the 7 -day observation.
CONCLUSION
The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.
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:
- 07 September - 17 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Ltd, Leicestershire, UK.
- At the start of the study the animals weighed 3.33 or 3.36 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days each animal was given a number, unique within the study, which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
- The animals were individually housed in suspended cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabitt diet supplied by Envigo RMS (UK), Oxon, UK) was allowed throughout the study.
- The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70 % respectively.
- Rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
- The animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1mL of test item
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72-hours
- Number of animals or in vitro replicates:
- Two
- Details on study design:
- TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was used as supplied.
- Absorption of the test material was not determined. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean scores
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- - Individual and group mean scores for occular irritation are given in Table 1 and Table 2 (attached).
- No corneal effects were noted during the study.
- Iridial inflammation was noted in one treated eyes 1 hour after application of the test item.
- Moderate conjunctival irritation was noted in both treated eyes at 1 hour after application of the test item with minimal conjunctival irritation noted at the 24 & 48 hour observation.
- Both treated eyes appeared normal at the 72-hour observation. - Other effects:
- BODY WEIGHT
- Individual body weights are given in Table 3 (attached).
- one animal showed body weight loss and the other animal showed expected gain in body weight during the study - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
- Executive summary:
GUIDELINE
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit using a procedure designed to be compatible with OECD Guideline for the Testing of Chemicals No 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2012) and EU Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No 440/2008.
RESULTS
A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both eyes appeared normal at the 72 hour observation.
CONCLUSION
The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for two animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.
Reference
MEASUREMENT OF pH
- Test item undiluted as supplied.
- Aqueous preparation of test item (10 % w/w): pH 5.8 immediately; pH 6.07 after 10 minutes.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B.4 Acute Toxicity (Skin Irritation).
RESULTS
A single 4 -hour, semi-occluded application of the test item to the intact skin of two rabbits produced very slight erythema and very slight edema. Both treated skin sites appeared normal at the 7 -day observation.
CONCLUSION
The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.
EYE
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit using a procedure designed to be compatible with OECD Guideline for the Testing of Chemicals No 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2012) and EU Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No 440/2008.
RESULTS
A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both eyes appeared normal at the 72 hour observation.
CONCLUSION
The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for two animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.
Justification for classification or non-classification
Skin: In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the primary effects, erythema and edema, were reversed by the end of the observation period. In addition, the scores for erythema and edema did not fall within the range requiring classification.
Eye: In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation because no corneal opacity was observed and iridial inflammation, conjunctival redness and chemosis were reversed by the end of the 72 hour observation period. Furthermore, the mean scores for each of the parameters do not fall within the range requiring classification.
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