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EC number: 700-541-9 | CAS number: 1472634-24-4
- 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
Key, acute toxicity, limit test, rat, oral (gavage), OECD 423, GLP: LD50 > 2000 mg/kg bw
Key, acute toxicity, limit test, rat, inhalation, aerosol, OECD 436, GLP: LD50 > 5500 mg/m3 air
Key, acute toxicity, limit test, rat, dermal, OECD 402, GLP: LD50 > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 APR - 28 JUN 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 DEC 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 8 weeks (males) and 9 weeks (females)
- Weight at study initiation: 180 g (range from 191 - 200 g (males), 164-172 g (females))
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23 °C
- Humidity (%): 52 to 75 %
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15 - Route of administration:
- oral: gavage
- Vehicle:
- other: Methocel K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: excellent vehicle performance in long range historical data
- Lot/batch no. (if required): DTl70406
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (m) / 3 (f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were seen in the 3 male and 3 female rats after treatment with 2000 mg/kg.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Other findings:
- None
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.
- Executive summary:
Study design
This GLP study was performed according to the OECD Guideline for Testing of Chemicals, No. 423: Acute Oral Toxicity - Acute Toxic Class Method (adopted on 17 December 2001) and according to Council Regulation (EC) No. 440/2008. The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight.
Results
No signs of toxicity were seen in the rats (3 males, 3 females) after treatment with 2000 mg/kg of the test item.
The body weight development of the rats was inconspicuous during the study.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.
Conclusion
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This GLP study was performed according to the OECD Guideline for Testing of Chemicals, No. 423: Acute Oral Toxicity - Acute Toxic Class Method (adopted on 17 December 2001) and according to Council Regulation (EC) No. 440/2008. Therefore, the quality of the database is high.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 AUG 2012 - 13 FEB 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- 7 SEP 2009
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WIST(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V.
- Age at study initiation: 9 weeks
- Weight at study initiation: Males: 262.5 to 268.5 g; Females: 184.4 to 195.1 g
- Fasting period before study: no
- Housing: in groups of 3 of the same sex in Makrolon type IV cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C,
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
IN-LIFE DATES: From: day 1 To: day 14 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Remarks:
- flow past
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- >= 1.37 - <= 1.97 µm
- Geometric standard deviation (GSD):
- >= 2.43 - <= 2.89
- Remark on MMAD/GSD:
- The particle size distribution of the generated aerosol was stable during the whole exposure period. The MMADs were at the lower limit of the target range of 1 to 4 μm. Therefore deposition of the particles can be assumed to have occurred mainly in the lower but also in the upper respiratory tract. The GSDs were within the target range of 1.5 to 3. Hence, the particle size distributions obtained were considered to be respirable to rats and appropriate for acute inhalation toxicity testing.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose only, flow past exposure chamber
- Method of holding animals in test chamber: animals were confined separately in restraint tubes
- Source and rate of air: 1.0 L/min
- System of generating particulates/aerosols: Hudson nebulizer connected to a Lomir syringe pump.
- Method of particle size determination: Gravimetric analysis of the test item deposited on each stage of the cascade impactor.
TEST ATMOSPHERE
Brief description of analytical method used: Gravimetric and chemical determinations of aerosol concentrations.
- Gravimetric determinations were performed twelve times during exposure. The samples were collected on GF/C filters, which were weighed before and after sampling. The test aerosol concentration was calculated from the amount of test item present on the filter and the sample volume.
- Chemical determinations were performed twelve times during exposure. The samples were collected on GF/C filters and analyzed using a LC-MS method.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
The particle size distribution of the test aerosol was determined three times during exposure using a Mercer 7 stage cascade Impactor. The particle size distribution was measured by gravimetrically analyzing the test item deposited on each stage of the cascade impactor. Mass Median Aerodynamic Diameters (MMAD) and Geometric Standard Deviations (GSD) were calculated on the basis of the results from the impactor. The target range was 1 to 4 μm for the MMAD and between 1.5 and 3 for the GSD.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The target concentration of 5 mg/L air for 4 hours is the recommended concentration for a limit test (OECD 436, “Acute Inhalation Toxicity - Acute Toxic Class Method”). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric and chemical determination
- Duration of exposure:
- 4 h
- Remarks on duration:
- The exposure was interrupted twice for a total of 10 minutes for cleaning purposes.
- Concentrations:
- 5.5 mg/L (chemically determined)
- No. of animals per sex per dose:
- 6 (3m / 3f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 1 (before exposure), 2, 4, 8 and 15 (before necropsy). For single animals body weight was determined additionally on test day 6.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic abnormalities - Statistics:
- No statistical analysis was performed as only one group was allocated to the study.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.5 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived the scheduled observation period.
- Clinical signs:
- other:
- Body weight:
- From test day 1 to test day 4, moderate to marked body weight loss was noted in two males (no. 1 and 2) and one female (no. 6). The remaining animals showed moderate to marked body weight loss from test day 1 to test day 2. Normal body weight development was recorded in all animals from test day 6 onwards.
- Gross pathology:
- No macroscopic findings were present at necropsy.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The LC50 for 4-hour exposure of the test material obtained in this study was greater than 5.5 mg/L air (chemically determined mean aerosol concentration of the active ingredient). There was no indication of relevant sex-related differences in toxicity of the test item.
- Executive summary:
Study design
This GLP study was performed according to OECD Guidelines for Testing of Chemicals, Section 4, No. 436: “Acute Inhalation Toxicity – Acute Toxic Class Method" (adopted September 7, 2009). In the study a group of three male and three female albino rats was exposed by nose-only, flow-past inhalation for four hours to the test material at a chemically determined mean concentration of 5.5 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure and the subsequent 14-day observation period. Body weights were recorded prior to exposure on test day 1, and during the observation period on test days 2, 4, 8 and 15 before necropsy and additionally on test day 6 as moderate to marked body weight loss was observed in single animals. On test day 15 all animals were sacrificed and necropsied.
The aerosol concentration, temperature, relative humidity, oxygen content and airflow rate measured during the exposure were considered to be satisfactory for a study of this type. In addition, the test item was considered to be respirable to rats.
Results
All animals survived the scheduled observation period. Clinical signs observed in this study consisted of decreased activity, ruffled fur and salivation in all animals, of labored breathing in all males and in two females, of breathing noises in single animals of both sexes, of hunched posture in all males and of excitement or tachypnea in one male and female, respectively. Clinical signs were of a slight to moderate severity and persisted mainly from test day 1 to test day 5. No clinical signs were recorded from test day 6 onwards. Moderate to marked body weight loss was noted in two males and one female from test day 1 to test day 4 and from test day 1 to test day 2 in the remaining animals. No macroscopic findings were recorded during necropsy.
Conclusion
In conclusion, the LC50 for 4 -hour exposure of the test material obtained in this study was greater than 5.5 mg/L air (chemically determined mean aerosol concentration of the active ingredient). There was no indication of relevant sex-related differences in toxicity of the test item.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 500 mg/m³ air
- Quality of whole database:
- This GLP study was performed according to OECD Guidelines for Testing of Chemicals, Section 4, No. 436: “Acute Inhalation Toxicity – Acute Toxic Class Method" (adopted 7 September 2009). Therefore, the quality of the database is high.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 OCT 2015 - 8 FEB 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 FEB 1987
- Deviations:
- yes
- Remarks:
- The room temperature during the study was transiently outside the anticipated range (measured temperature 18.9 - 24.1°C). This minor transient deviation did not influence the integrity or outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz (18 NOV 2014)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 267 - 271g (males), 210 - 221g (females)
- Housing: The rats were kept individually in type III Makrolon cages, with a shelter and a play tunnel, on softwood bedding material.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 24.1°C
- Humidity (%): 47.2 - 67.3%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: day 1 To: day 15 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 36 cm²
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residue of the test item was wiped off with a dry cloth.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dermal administration of 2000 mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 (5f / 5m)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, 15
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen.
- Clinical signs:
- other: No clinical signs of toxicity were observed. The application site was brownish stained in all rats after removal of the gauze patch and test item.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item revealed no acute toxic potential after single dermal administration in rats. The LD50 value is considered to be higher than 2000 mg/kg.
- Executive summary:
Study design
This GLP study was performed according to the OECD Guideline for Testing of Chemicals 402: "Acute dermal toxicity" (adopted on February 24, 1987) and the Council Regulation (EC) No. 440/2008. The test item was applied to the skin of 5 female and 5 male rats at 2000 mg/kg (limit test) by single dermal administration for 24 hours followed by a 2 -week observation period. Mortality and clinical signs were monitored for at least 6 hours after start of exposure and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
Results
No mortality occurred during the course of this study.
No clinical signs of toxicity were observed.
The body weight development was inconspicuous throughout the study.
The gross pathological examination revealed no organ alterations.
Conclusion
Under the conditions of the present study, the test item revealed no acute toxic potential after single dermal administration in rats. The LD50 value is considered to be higher than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This GLP study was performed according to the OECD Guideline for Testing of Chemicals 402: "Acute dermal toxicity" (adopted on 24 February 1987) and the Council Regulation (EC) No. 440/2008. Therefore, the quality of the database is high.
Additional information
Acute toxicity - Oral
Acute oral toxicity, OECD 423
The acute oral toxicity of the test item was determined in a limit test, following GLP and according to the OECD Guideline for Testing of Chemicals, No. 423: Acute Oral Toxicity - Acute Toxic Class Method (adopted on 17 December 2001) and according to Council Regulation (EC) No. 440/2008.
Study design
In the study test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight.
Results
No signs of toxicity were seen in the rats
(3 males, 3 females) after treatment with 2000 mg/kg of the test item.
The body weight development of the rats was inconspicuous during the
study.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.
Conclusion
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.
Acute toxicity - inhalation
Acute inhalation toxicity, OECD 436
The acute inhalation toxicity of the test item was determined in a limit test, follwing GLP and according to OECD Guidelines for Testing of Chemicals, Section 4, No. 436: “Acute Inhalation Toxicity – Acute Toxic Class Method" (adopted on 7September 2009).
Study design
In the study a group of three male and three female albino rats was exposed by nose-only, flow-past inhalation for four hours to the test material at a chemically determined mean concentration of 5.5 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure and the subsequent 14-day observation period. Body weights were recorded prior to exposure on test day 1, and during the observation period on test days 2, 4, 8 and 15 before necropsy and additionally on test day 6 as moderate to marked body weight loss was observed in single animals. On test day 15 all animals were sacrificed and necropsied.
The aerosol concentration, temperature, relative humidity, oxygen content and airflow rate measured during the exposure were considered to be satisfactory for a study of this type. In addition, the test item was considered to be respirable to rats.
Results
All animals survived the scheduled observation period. Clinical signs observed in this study consisted of decreased activity, ruffled fur and salivation in all animals, of labored breathing in all males and in two females, of breathing noises in single animals of both sexes, of hunched posture in all males and of excitement or tachypnea in one male and female, respectively. Clinical signs were of a slight to moderate severity and persisted mainly from test day 1 to test day 5. No clinical signs were recorded from test day 6 onwards. Moderate to marked body weight loss was noted in two males and one female from test day 1 to test day 4 and from test day 1 to test day 2 in the remaining animals. No macroscopic findings were recorded during necropsy.
Conclusion
In conclusion, the LC50 for 4 -hour exposure of the test material obtained in this study was greater than 5.5 mg/L air (chemically determined mean aerosol concentration of the active ingredient). There was no indication of relevant sex-related differences in toxicity of the test item.
Acute toxicity - dermal
Acute dermal toxicity, OECD 402
The acute oral toxicity of the test item was determined in a limit test, following GLP and according to the OECD Guideline for Testing of Chemicals 402: "Acute dermal toxicity" (adopted on 24 February 1987) and the Council Regulation (EC) No. 440/2008.
Study design
In the study the test item was applied to the skin of 5 female and 5 male rats at 2000 mg/kg (limit test) by single dermal administration for 24 hours followed by a 2 -week observation period. Mortality and clinical signs were monitored for at least 6 hours after start of exposure and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
Results
No mortality occurred during the course of this study.
No clinical signs of toxicity were observed.
The body weight development was inconspicuous throughout the study.
The gross pathological examination revealed no organ alterations.
Conclusion
Under the conditions of the present study, the test item revealed no acute toxic potential after single dermal administration in rats. The LD50 value is considered to be higher than 2000 mg/kg.
Justification for classification or non-classification
Based on the results of the key study (LD50 in rats > 2000 mg/kg bw), no classification for acute oral toxicity is triggered in accordance with Regulation (EC) No 1272/2008.
Based on the results of the key study (LD50 in rats > 5500 mg/m3 air) no classification for acute inhalation toxicity is triggered in accordance with Regulation (EC) No 1272/2008.
Based on the results of the key study (LD50 in rats > 2000 mg/kg), no classification for acute dermal toxicity is triggered in accordance with Regulation (EC) No 1272/2008.
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