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EC number: 474-190-2 | CAS number: 875471-31-1
- 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.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:
- Between 08 and 20 November, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 with deviations not affecting the reliability of the study: details on feeding and environmental conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- yes
- Remarks:
- details on feeding and environmental 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:
- details on feeding and environmental conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-07-01 / Signed on 2004-09-13.
- 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: 2.74 - 3.46 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: 17-22 °C
- Humidity: 30-58 %
- Air changes: no data
- Photoperiod: no data
IN-LIFE DATES: From 08 to 20 November, 2005. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
- Number of animals:
- 3 males
- Details on study design:
- PRETEST
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: Undamaged skin area of the right flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: no data.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of 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: 2 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: 4 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 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:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak 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 slight to important erythema in the 3 animals, associated with a slight oedema in two animals, was noted 24 hours after the test item application.
- The oedematous reactions were totally reversible the 3rd day of the test and the erythematous reactions were totally reversible between the 4th and the 5th day of the test.
- On the cutaneous structure, the skin recovered a normal aspect, between the 5th and the 12th 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, 0.5 mL of undiluted test item was applied on an undamaged skin area of the flank of 3 male New Zealand White rabbits. On the other 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 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
A slight to important erythema in the 3 animals, associated with a slight oedema in two animals was noted 24 hours after the test item application. The oedematous reactions were totally reversible the 3rd day of the test and the erythematous reactions were totally reversible between the 4th and the 5th day of the test. On the cutaneous structure, the skin recovered a normal aspect, between the 5th and the 12th day of the test.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.3 / 1.7 / 0.7 for erythema and 0.3 / 0.3 / 0.0 for oedema.
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.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
Reference
Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A6977/male |
A6981/male |
A6982/male |
||
Erythema/Eschar formation |
1 h |
2 |
2 |
1 |
24 h |
3 |
2 |
1 |
|
48 h |
2 |
2 |
1 |
|
72 h |
2 |
1 |
0 |
|
Day 4 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
7 |
5 |
2 |
|
Mean (24, 48 and 72 hours) |
2.3 |
1.7 |
0.7 |
Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A6977/male |
A6981/male |
A6982/male |
||
Oedema formation |
1 h |
1 |
0 |
0 |
24 h |
1 |
1 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
1 |
1 |
0 |
|
Mean (24, 48 and 72 hours) |
0.3 |
0.3 |
0 |
Note:
A6977: slight dryness from D2 to D3 and from D9 to D10, dryness from D4 to D8
A6981: slight dryness at D2, dryness from D3 to D4
A6982: slight dryness from D2 to D3
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:
- Between 21 and 25 November 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 405 with deviations not affecting the reliability of the study: details on feeding and environmental conditions not reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-07-01 / Signed on 2004-09-13.
- 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: 2.25 - 3.24 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: 18-23 °C
- Humidity: 26-43 %. A relative humidity of 26% was registered instead of 30% (minimal limit) as planned in the experimental protocol. This deviation did not, in any case, influence the development and the results of the study.
- Air changes: no data.
- Photoperiod: no data.
IN-LIFE DATES: from 21 to 25 November, 2005. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Test item was instilled, as supplied - 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 & Day 4 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 males
- 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:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of 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
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- 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:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 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:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 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:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 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
- Max. score:
- 4
- Reversibility:
- other: not applicable.
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 5th day of the test, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 3rd day of the test ;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation, in only one animal, and totally reversible the 4th day of the test. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 3 New Zealand White male rabbits were exposed to 0.1 mL of test item in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and day 4 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
A slight redness noted 1 hour after the test item instillation and totally reversible between the 3rd and the 5th day of the test, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 3rd day of the test. At the corneal level, a moderate opacity, registered 24 hours after the test item instillation, in only one animal, and totally reversible the 4th day of the test.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 1.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.0, 0.7, 0.3 for conjunctivae score and 0.3, 0.0, 0.0 for chemosis score. These effects are reversible between days 2 and 4.
Under the test conditions, the test material is not classified as irritating to eyes according to the Regulation (EC) No. 1272/2008 (CLP) and 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 for Cornea, Iris and Conjunctivae
Rabbit Number and Sex
|
Time After Treatment
|
Corneal Opacity
|
Iris lesion |
Conjunctival Redness
|
Conjunctival Chemosis
|
A 6986 Male
|
1 h |
0 |
0 |
1 |
1 |
24 h |
0 |
0 |
1 |
1 |
|
48 h |
0 |
0 |
1 |
0 |
|
72 h |
0 |
0 |
1 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
3 |
1 |
|
Mean (24, 48 and 72 h) |
0 |
0 |
1 |
0.3 |
Rabbit Number and Sex
|
Time After Treatment
|
Corneal Opacity
|
Iris lesion |
Conjunctival Redness
|
Conjunctival Chemosis
|
A7020 Male
|
1 h |
0 |
0 |
1 |
1 |
24 h |
0 |
0 |
1 |
0 |
|
48 h |
0 |
0 |
1 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
2 |
0 |
|
Mean (24, 48 and 72 h) |
0 |
0 |
0.7 |
0 |
Rabbit Number and Sex
|
Time After Treatment
|
Corneal Opacity
|
Iris lesion |
Conjunctival Redness
|
Conjunctival Chemosis
|
A 7021 Male
|
1 h |
0 |
0 |
1 |
2 |
24 h |
2 |
0 |
1 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
3 |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
1 |
0 |
0.3 |
0 |
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, 2005). 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 slight to important erythema in the 3 animals, associated with a slight oedema in two animals was noted 24 hours after the test item application. The oedematous reactions were totally reversible the 3rd day of the test and the erythematous reactions were totally reversible between the 4th and the 5th day of the test. On the cutaneous structure, the skin recovered a normal aspect, between the 5th and the 12th day of the test.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.3 / 1.7 / 0.7 for erythema and 0.3 / 0.3 / 0.0 for oedema.
Eye irritation:
A key study was identified (Phycher, 2005). 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 eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Day 4 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
A slight redness noted 1 hour after the test item instillation and totally reversible between the 3rd and the 5th day of the test, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 3rd day of the test. At the corneal level, a moderate opacity, registered 24 hours after the test item instillation, in only one animal, and totally reversible the 4th day of the test.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 1.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.0, 0.7, 0.3 for conjunctivae score and 0.3, 0.0, 0.0 for chemosis score. These effects are reversible between days 2 and 4.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized 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
- the substance is classified in "Category 3 (mild irritant)" according to the GHS.
Eye irritation:
Based on the available data, no self-classification is proposed regarding eye irritation according to the CLP and to the GHS.
Respiratory irritation:
No data was available regarding respiratory irritation.
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