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EC number: 478-950-4 | 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
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (OECD 404, GLP, K, Rel.1)
Eye irritation: not irritating (OECD 405, GLP, K, Rel.1)
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:
- 21 March to 07 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 404 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2005-10-03 / Signed on 2005-12-13.
- Specific details on test material used for the study:
- - Test item was considered at 100% for the study.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste – F40260 Linxe
- Weight at study initiation: 2.48-2.86 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 30-59 %
IN-LIFE DATES: 21 March to 07 April 2006 - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: On the left flank an untreated area was served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.
- Number of animals:
- 3 males
- Details on study design:
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: The test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of the right flank of each animal.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
- Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.
SCORING SYSTEM: According to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- 24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test.
On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test. - Other effects:
- None
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, undiluted test substance was applied at the dose of 0.5 mL, under semiocclusive dressing during 4 hours on an undamaged skin area of 3 rabbits. On the opposite flank an untreated area was served as the control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 h and Days 4 to 10 after the removal of the patch. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test. On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.7 / 2.0 for erythema and 0.3 / 0.7 / 0.3 for oedema.
Under the test conditions, the test substance is not classified according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
Reference
Table 7.3.1/1: Individual and average scores after 4 h exposure
Observations |
Score |
|||
Skin reactions |
Observation time |
Animal no.A7286 |
Animal no.A7303 |
Animal no.A7304 |
Erythema and eschar |
1 h |
2 |
2 |
2 |
24 h |
2 |
2 |
2 |
|
48 h |
1 |
2 |
2 |
|
72 h |
0 |
1 |
2 |
|
Day 4 |
0 |
0 |
2 |
|
Day 5 |
- |
0 |
1 |
|
Day 6 |
- |
0 |
0 |
|
Day 7 |
- |
0 |
0 |
|
Day 8 |
- |
0 |
0 |
|
Day 9 |
- |
0 |
0 |
|
Day 10 |
- |
0 |
0 |
|
Mean (24, 48 and 72 h) |
1.0 |
1.7 |
2.0 |
|
Oedema formation |
1 h |
1 |
1 |
1 |
24 h |
1 |
1 |
1 |
|
48 h |
0 |
1 |
0 |
|
72 h |
0 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
|
Day 5 |
- |
0 |
0 |
|
Day 6 |
- |
0 |
0 |
|
Day 7 |
- |
0 |
0 |
|
Day 8 |
- |
0 |
0 |
|
Day 9 |
- |
0 |
0 |
|
Day 10 |
- |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.3 |
0.7 |
0.3 |
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:
- 20-30 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 405 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 2004/73/EC.
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2005-10-03 / Signed on 2005-12-13.
- Specific details on test material used for the study:
- - Test item was considered at 100% for the study.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste – F40260 Linxe
- Weight at study initiation: 2.34-2.61 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 38-61 %
IN-LIFE DATES: 20-30 April 2006 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye serving as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- No washing was done
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 4, 5 and 6 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
A volume of 0.1 mL of the pure test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between the 4th and the 6th day of the test, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 4th day of the test;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation in two animals and totally reversible between the 3rd and the 7th day of the test. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance is not classified as irritating to eyes according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405 Guideline and in compliance with GLP, test substance was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL, the other eye remained untreated serving as control. The lids were then gently held together for about one second in order to prevent loss of the test substance. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and 4, 5 and 6 days after treatment and graded according to the Draize method.
The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between the 4th and the 6th day of the test, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 4th day of the test;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation in two animals and totally reversible between the 3rd and the 7th day of the test.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.7, 0.0, 1.7 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.3, 1.0, 1.7 for conjunctivae score and 1.0, 0.3, 0.3 for chemosis score.
Under the test conditions, test substance is not classified as irritating to eyes according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 7.3.2/1: Individual and mean scores of conjunctivae, iris and cornea
Time / Animal
|
Cornea
|
Iris
|
Conjunctivae
|
|||||||||
redness
|
chemosis
|
|||||||||||
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
24 h |
2 |
0 |
2 |
0 |
0 |
0 |
2 |
2 |
2 |
2 |
1 |
1 |
48 h |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
1 |
2 |
1 |
0 |
0 |
72 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
D4 |
0 |
- |
1 |
0 |
- |
0 |
1 |
- |
0 |
0 |
- |
0 |
D5 |
0 |
- |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
D6 |
- |
- |
0 |
- |
- |
0 |
- |
- |
0 |
- |
- |
0 |
Total 24/48/72 h |
2 |
0 |
5 |
0 |
0 |
0 |
4 |
3 |
5 |
3 |
1 |
1 |
Mean 24/48/72 h |
0.7 |
0.0 |
1.7 |
0.0 |
0.0 |
0.0 |
1.3 |
1.0 |
1.7 |
1.0 |
0.3 |
0.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study was identified (Phycher, 2006). In this dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 3 male New Zealand White rabbits were exposed for 4 hours to a semi-occluded application of 0.5 mL of undiluted test material to the intact skin. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test. On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.7 / 2.0 for erythema and 0.3 / 0.7 / 0.3 for oedema.
Eye irritation:
A key study was identified (Phycher, 2006). In this eye irritation study performed according to the OECD guideline 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 3 female New Zealand White rabbits. The other eye remained untreated and served as control. The lids were then gently held together for about one second in order to prevent loss of the test substance. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and 4, 5 and 6 days after treatment and graded according to the Draize method.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.7/0.0/1.7 for the corneal opacity, 0.0/0.0/0.0 for iridial inflammation, 1.3/1.0/1.7 for conjunctival redness and 1.0/0.3/0.3 for chemosis. The effects observed were all reversible within 7 days.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available data:
- no additional self-classification is proposed regarding both skin and eye irritation according to the CLP.
- the substance is classified in Category 3 (mild irritant) for skin irritation according to the GHS.
- No data was available regarding respiratory irritation. However, the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.
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.
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