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EC number: 685-617-9 | CAS number: 1099648-69-7
- 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: not irritating (OECD 404, GLP, K, Rel.2)
Eye irritation: irritating (OECD 405, GLP, K, Rel.2)
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:
- 18-28 March 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD 404 Guideline without any deviation. However, isomers ratio is not reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21.
- 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)
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.36-2.85 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: Foodstuff (SDS –C15), ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 39-68 %
- Air changes: at least ten changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 18-28 March 2008 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: On the opposite flank an untreated area was used as 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, 24, 48 and 72 h after removal of the patch.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 h before the test, the rabbit’s back and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2 per patch.
- As no tissue destruction was noted after a treatment during 3 minutes and 1 hour, the test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of one flank of each animal, during 4 hours.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape under semiocclusive dressing.
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
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:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- 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:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema 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:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- 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
- Irritant / corrosive response data:
- A very slight erythema was noted, in two animals, only at the reading time 1 hour.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance is not classified as irritatng to skin according to the criteria of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item was applied on the shorn skin of the flanks of 3 male New Zealand White rabbits. On the opposite flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h 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 during 4 hours.
A very slight erythema was noted, in two animals, only at the reading time 1 hour. The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and 0.0 / 0.0 / 0.0 for oedema.
Under the test conditions, test substance is not classified according to the criteria of the Regulation EC No. 1272 /2008 (CLP) and 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. A8862 |
Animal no. A8876 |
Animal no. A8877 |
Erythema and eschar |
1 h (D0) |
0 |
1 |
1 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.0 |
|
Oedema formation |
1 h (D0) |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.0 |
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:
- 25 March to 11 April 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD 405 Guideline without any deviation. However, the isomers ratio is not reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21.
- 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)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.73-3.11 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: Foodstuff (SDS- C15), ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19–23 °C
- Humidity: 42-60 %
- Air changes: at least ten changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 25 March to 11 April 2008 - 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 to 21 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- TREATMENT
- 0.1 mL of the test item was instilled, as supplied, 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:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak 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: 8 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:
- 0.7
- 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:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive 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:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- 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:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- 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: 11 days
- Remarks on result:
- probability of weak 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:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 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:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- 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 D6 and D8, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D3 and D5;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D7 and D11,
- at the iris level: a congestion only noted 24 hours after the test item instillation in one animal. - Other effects:
- None
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test substance is classified for eye irritation in Category 2 (H319: Causes severe eye irritation) according to the Regulation (EC) No. 1272/2008 (CLP) and in Category 2A "irritating to eyes" according to the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405/EU Method B.5 guidelines and in compliance with GLP, 3 New Zealand White female rabbits were exposed to 0.1 mL of test substance in one eye while the contralateral 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 item. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 4 to 11 following 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 D6 and D8, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D3 and D5;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D7 and D11,
- at the iris level: a congestion only noted 24 hours after the test item instillation in one animal.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2.0, 2.0, 1.7 for cornea score; 0.3, 0.0, 0.0 for iris score; 1.3, 1.3, 1.3 for conjunctivae score and 0.7, 1.3, 1.3 for chemosis score.
Under the test conditions, test substance is classified for eye irritation in Category 2 (H319: Causes severe eye irritation) according to the Regulation (EC) No. 1272/2008 (CLP) and in Category 2A "irritating to eyes" according to 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 No. |
Cornea |
Iris |
Conjunctivae |
|||||||||
redness |
chemosis |
|||||||||||
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
|
24h |
2 |
2 |
2 |
1 |
0 |
0 |
2 |
2 |
2 |
1 |
2 |
2 |
48h |
2 |
2 |
2 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
72h |
2 |
2 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
Day 4 |
|
2 |
1 |
|
0 |
0 |
|
1 |
1 |
|
1 |
0 |
Day 5 |
|
1 |
1 |
|
0 |
0 |
|
1 |
1 |
|
0 |
0 |
Day 6 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
Day 7 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
Day 8 |
1 |
|
1 |
0 |
|
0 |
0 |
|
0 |
0 |
|
0 |
Day 9 |
0 |
|
1 |
0 |
|
0 |
0 |
|
0 |
0 |
|
0 |
Day 10 |
|
|
1 |
|
|
0 |
|
|
0 |
|
|
0 |
Day 11 |
|
|
0 |
|
|
0 |
|
|
0 |
|
|
0 |
Mean 24/48/72h |
2.0 |
2.0 |
1.7 |
0.3 |
0.0 |
0.0 |
1.3 |
1.3 |
1.3 |
0.7 |
1.3 |
1.3 |
#1:A8893; #2:A8894; #3:A8895
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study was identified (Phycher, 2008, Re.2). 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.
A very slight erythema was noted, in two animals, only at the reading time 1 hour. The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and 0.0 / 0.0 / 0.0 for oedema. The substance is therefore not classified for skin irritation.
Eye irritation:
A key study was identified (Phycher, 2008, Rel.2). 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 Days 4 to 11 following 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 2.0, 2.0, 1.7 for cornea score; 0.3, 0.0, 0.0 for iris score; 1.3, 1.3, 1.3 for conjunctivae score and 0.7, 1.3, 1.3 for chemosis score. The effects observed were all reversible within 11 days. The substance is therefore classified as "Category 2A irritating to eyes".
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:
Skin irritation:
Based on the available data, no self-classification is proposed regarding skin irritation according to the CLP and according to the GHS.
Eye irritation:
Based on the available data, the substance should be classified as eye irritation Category 2 (H319: Causes serious eye irritation) according to the CLP and as Category 2A "irritating to eyes" according to the GHS.
Respiratory irritation:
No data was available regarding respiratory irritation.
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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.