Registration Dossier
Registration Dossier
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EC number: 293-878-1 | CAS number: 91648-19-0
Endpoint summary
Administrative data
Description of key information
An acute oral toxicity study is available for the submission substance [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts]; a supporting study with the read-across (analogue) substance [Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 (even numbered) acyl) derivs., hydroxides, inner salts] is also available. Both studies report acute oral LD50 values of >2000 mg/kg bw.
A waiver is provided for acute inhalation toxicity based on exposure considerations.
An acute dermal toxicity study is available for the submission substance.
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:
- 25th May to 27th July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Betadet SHR
Lot number: 7049
Appearance: viscous yellowish liquid
pH: 7.48
Storage: Room temperature; protected from light - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight on arrival: 80-95g
Age on arrival: Approximately 4 weeks
Source: Charles River, supplied by Criffa, S.A
Housing: Makrolon cages with sawdust bedding, up to 5 rats of same sex
Acclimatisation period: At least 5 days
Weight at start of study: 100g (preliminary study); 107-122g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86% (generally within 40-70%)
Photoperiod: 12 hours light/dark cycle
Diet: Standard rat diet UAR A04C, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, S.A; ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- In the preliminary study, one female was dosed with 2000 mg/kg bw .In the main study, five males and five females were dosed with 2000 mg/kg bw. Animals were fasted 18 hour prior to treatment. The test substance was administered orally by gastric intubation using a metal catheter. The solutions were prepared immediately prior to dosing. A single dose was given at a volume of 10 mL/kg bw. The quantity was based on bodyweight at the time of dosing. Food was replaced three hours following dosing.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five (additional female used in preliminary study).
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- The rats were observed at least twice daily for 7 days (preliminary study) or for 14 days (main study), after which they were sacrificed. Observations included changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous systems, somatomotor activity and behaviour patterns.
Body weights were recorded before administration, daily for the first three days, then weekly and prior to being sacrificed. Rats were sacrificed by carbon dioxide inhalation. The animals in the main study were subjected to necropsy. The necropsy included a revision of the intact animal and its superficial tissues, followed by observation of the cranial, thoracic and abdominal cavities in situ and after evisceration. - Preliminary study:
- No mortality was observed. The female presented soft faeces on the day following treatment. No other clinical signs were noted. The animal showed normal body growth.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No deaths occurred at the limit dose of 2000 mg/kg bw
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted.
- Gross pathology:
- No visible macroscopic lesions were noted which were treatment related.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No deaths were observed in this study at the limit dose of 2000 mg/kg bw. Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted. The substance is not classified for acute oral toxicity under CLP.
- Executive summary:
An acute oral toxicity study with Betadet SHR was conducted using a fixed dose method. Wistar rats were dosed with 2000 mg/kg bw. A preliminary experiment comprising one female showed no mortality. Soft faeces were noted on the day following treatment. No other clinical signs were noted during the seven day observation period. A main experiment comprised five animals/sex. Soft faeces were noted on the day following treatment. There were no other clinical signs, mortality or post mortem observations. Body weight gain was normal. The overall conclusion of the study was that the test material showed no significant signs of toxicity. The substance is not classified for acute oral toxicity under CLP.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: not provided
- Weight at study initiation: 171-276 g (males), 164-216 g (females)
- Fasting period before study: from 16 hours before until 3-4 hours after administration
- Housing: up to a maximum of 5 rats per cage (Macrolon type III cage)
- Diet (e.g. ad libitum): not detailed
- Water (e.g. ad libitum): not detailed
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-85
- Air changes (per hr): not detailed
- Photoperiod (hrs dark / hrs light): 12 / 12 (7.00 am-7.00 pm)
IN-LIFE DATES: Not provided - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
No vehicle used (solution administered as such with different dosing volumes)
MAXIMUM DOSE VOLUME APPLIED:
1000 mg/kg: 2.33 mL/kg bw
2000 mg/kg: 4.65 mL/kg bw
3000 mg/kg: 6.98 mL/kg bw - Doses:
- 1000, 2000 and 3000 mg active component/ kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Examinations performed: mortality (over the 24-hour post-dosing period, and then daily), clinical signs (daily), body weights (just before dosing, on days 7 and 14)
- Necropsy of survivors performed: yes - Statistics:
- The method of Finney D.Y., Probit Analysis (3rd ed., Cambridge, 1971) was used for calculating the oral LD50.
- Preliminary study:
- One animal died within 24 hours of dosing at 2000 mg/kg
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks on result:
- other: Could not be calculated because only at the high dose pre-terminal deaths were lower than 100% and higher than 0%
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 020 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: at 24 h and 14 days after dosing
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 950 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: at 24 h and 14 days after dosing
- Mortality:
- Deaths occurred at 3000 mg/kg bw (3M, 2F) and at 2000 mg/kg bw (2F).
- Clinical signs:
- other: Up to 3 days post-dosing, reduced general activity was observed at 3000 mg/kg, together with squatting position, reduced skin turgor, cyanosis, diarrhea and piloerection on some occasions.
- Gross pathology:
- - 2000 and 3000 mg/kg: animals killed in extremis within 24 hours post-dosing showed hemorrhagic and lytic alterations in the gatro-intestinal tract and/or yellow-orange discoloration of lungs and/or reddish pelvis at macroscopic examination.
- At terminal sacrifice (14 days post-dosing): no test-article abnormalities noted at necropsy. - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral toxicity of the substance is therefore >2000 mg/kg bw based on the results of this study; classification for acute oral toxicity is not required based on the CLP criteria.
- Executive summary:
C8 -18 cocamidopropyl hydroxysultaine (as a 42% aqueous solution) was tested for acute oral toxicity in Wistar rats according to OECD 401. The test material was administered without dilution and using different dosing volumes. Three groups of five rats/sex were dose with 1000, 2000 and 3000 mg kg bw (as the active component) and observed for 14 days. Deaths occurred at 3000 mg/kg bw (3M, 2F) and at 2000 mg/kg bw (2F). No deaths occurred at 1000 mg/kg bw. Clinical signs (including reduced activity, diarrhoea, squatting position, piloerection) were observed at 3000 mg/kg bw. Bodyweight gain was normal in surviving animals. Haemorrhagic and lytic mucous membrane alterations in the gastrointestinal tract were observed at necropsy of decedents at 2000 and 3000 mg/kg bw. No findings were noted at scheduled necropsy. The acute oral toxicity of the substance is therefore >2000 mg/kg bw based on the results of this study
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance, C8-C18 AAPHS, has the same functional groups and general composition as the target C12-14 substance. The main variable resides in the alkyl chain distribution.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source substance = C8-18 cocamidopropyl hydroxysultaine (EC 939-455-3).
Target substance = C12-14 cocamidopropyl hydroxysultaine (EC 293-878-1).
3. ANALOGUE APPROACH JUSTIFICATION
Cf. attached Read-Across Justification Document (§13 Assessment reports).
4. DATA MATRIX
Cf. attached Read-Across Justification Document (§13 Assessment reports). - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: not provided
- Weight at study initiation: 171-276 g (males), 164-216 g (females)
- Fasting period before study: from 16 hours before until 3-4 hours after administration
- Housing: up to a maximum of 5 rats per cage (Macrolon type III cage)
- Diet (e.g. ad libitum): not detailed
- Water (e.g. ad libitum): not detailed
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-85
- Air changes (per hr): not detailed
- Photoperiod (hrs dark / hrs light): 12 / 12 (7.00 am-7.00 pm)
IN-LIFE DATES: Not provided - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
No vehicle used (solution administered as such with different dosing volumes)
MAXIMUM DOSE VOLUME APPLIED:
1000 mg/kg: 2.33 mL/kg bw
2000 mg/kg: 4.65 mL/kg bw
3000 mg/kg: 6.98 mL/kg bw - Doses:
- 1000, 2000 and 3000 mg active component/ kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Examinations performed: mortality (over the 24-hour post-dosing period, and then daily), clinical signs (daily), body weights (just before dosing, on days 7 and 14)
- Necropsy of survivors performed: yes - Statistics:
- The method of Finney D.Y., Probit Analysis (3rd ed., Cambridge, 1971) was used for calculating the oral LD50.
- Preliminary study:
- One animal died within 24 hours of dosing at 2000 mg/kg
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks on result:
- other: Could not be calculated because only at the high dose pre-terminal deaths were lower than 100% and higher than 0%
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 020 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: at 24 h and 14 days after dosing
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 950 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: at 24 h and 14 days after dosing
- Mortality:
- Deaths occurred at 3000 mg/kg bw (3M, 2F) and at 2000 mg/kg bw (2F).
- Clinical signs:
- other: Up to 3 days post-dosing, reduced general activity was observed at 3000 mg/kg, together with squatting position, reduced skin turgor, cyanosis, diarrhea and piloerection on some occasions.
- Gross pathology:
- - 2000 and 3000 mg/kg: animals killed in extremis within 24 hours post-dosing showed hemorrhagic and lytic alterations in the gatro-intestinal tract and/or yellow-orange discoloration of lungs and/or reddish pelvis at macroscopic examination.
- At terminal sacrifice (14 days post-dosing): no test-article abnormalities noted at necropsy. - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral toxicity of the substance is therefore >2000 mg/kg bw based on the results of this study; classification for acute oral toxicity is not required based on the CLP criteria.
- Executive summary:
C12 -18 cocamidopropyl hydroxysultaine (as a 42% aqueous solution) was tested for acute oral toxicity in Wistar rats according to OECD 401. The test material was administered without dilution and using different dosing volumes. Three groups of five rats/sex were dose with 1000, 2000 and 3000 mg kg bw (as the active component) and observed for 14 days. Deaths occurred at 3000 mg/kg bw (3M, 2F) and at 2000 mg/kg bw (2F). No deaths occurred at 1000 mg/kg bw. Clinical signs (including reduced activity, diarrhoea, squatting position, piloerection) were observed at 3000 mg/kg bw. Bodyweight gain was normal in surviving animals. Haemorrhagic and lytic mucous membrane alterations in the gastrointestinal tract were observed at necropsy of decedents at 2000 and 3000 mg/kg bw. No findings were noted at scheduled necropsy. The acute oral toxicity of the substance is therefore >2000 mg/kg bw based on the results of this study
Referenceopen allclose all
No deaths occurred at the limit dose of 2000 mg/kg bw.
Dose (mg/kg) |
Summary of mortality |
|||||
Males |
Females |
|||||
24 hours |
7 days |
14 days |
24 hours |
7 days |
14 days |
|
1000 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
2000 |
0/5 |
0/5 |
0/5 |
2/5 |
2/5 |
2/5 |
3000 |
3/5 |
3/5 |
3/5 |
2/5 |
2/5 |
2/5 |
Dose (mg/kg) |
Summary of mortality |
|||||
Males |
Females |
|||||
24 hours |
7 days |
14 days |
24 hours |
7 days |
14 days |
|
1000 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
2000 |
0/5 |
0/5 |
0/5 |
2/5 |
2/5 |
2/5 |
3000 |
3/5 |
3/5 |
3/5 |
2/5 |
2/5 |
2/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A modern, guideline-compliant study is available for the submission susbtance and is supported by older data for the read-across (analogue) substance.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- February - August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 320-348 g (males) - 214-248 g (females)
- Fasting period before study: No
- Housing: By 5 from the same sex and group in polycarbonate cages with stainless steel lids containing autoclaved sawdust, with nylabone used as enrichment
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days (males) - 5 days (females) before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 05 March 2012 To: 23 March 2012 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 7 x 5 cm for males, 6 x 5 cm for females
- % coverage: approx. 10% of total body surface
- Type of wrap if used: Application site covered with aerated hypoallergic dressing
REMOVAL OF TEST SUBSTANCE
No washing
TEST MATERIAL
- Solution applied as is.
- Quantity of test item applied adjusted based on the body weight recorded on the day of application.
- Correction factor of 2.76 used to calculate the dosage volume to be applied taking account of the solution purity. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg active ingredient/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
. Morbidity / mortality: frequently during hours following application, at least once daily for the remainder of the observation period
. Clinical signs: at least once during first 30 minutes, periodically during first 4 hours, once daily for the remainder of the observation period
. Bodyweight: recorded on the day of group allocation, then on the day of application (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes (spleen was preserved in 10% buffered formalin, stored, and destroyed at finalization of study report) - Statistics:
- No statistical analyses included
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No unscheduled deaths observed
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity observed. Very slight or well defined erythema noted at application site for 2 females on day 2.
- Gross pathology:
- Enlargement of the spleen was found in all treated animals but was considered incidental as it is part of the normal background in untreated rats of these strain and age.
- Other findings:
- Due to enlargement seen at necropsy, spleens were preserved in 10% buffered formalin and stored. In the absence of toxicological relevance, no histopathology was conducted and these organs were therefore destroyed upon finalization of the study report.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 in rats was higher than 2000 mg active ingredient/kg bw.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 36.2% solution (Mackam CBS-50GE), has been tested for acute dermal toxicity in Sprague-Dawley rats. The test article was applied as a single dose under a semi-occlusive dressing for 24 hours. One group of 5 rats per sex received a dose of 2000 mg active ingredient/kg bw. Examinations for mortality and clinical signs were performed daily during the 14 -day study period. Animals were necropsied at the end of the observation period.
No mortality was observed. No clinical signs indicative of systemic toxicity were observed. Very slight or well defined erythema was noted at the application site for 2 females on day 2. Mean bodyweight gain was slightly lower than historical control data for females over the observation period, notably during the first week following application. However, no such changes were observed for males. Enlargement of the spleen was found in all treated animals but was considered incidental as it is part of the normal background in untreated rats of these strain and age.
The dermal LD50 in rats was therefore higher than 2000 mg active ingredient/kg bw.
Reference
|
Females |
Males |
||
Historical controls |
Treated |
Historical controls |
Treated |
|
Dose level (mg/kg) |
0 |
2000 |
0 |
2000 |
Days 1-8 |
+36 |
+21 |
+45 |
+41 |
Days 8-15 |
+18 |
+16 |
+45 |
+44 |
Days 1-15 |
+55 |
+37 |
+90 |
+84 |
Mean bodyweight gains (grams) during the observation period
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A guideline-compliant study is available for the submission substance.
Additional information
Acute oral toxicity
An acute oral toxicity study with the submission substance Betadet SHR [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts] was conducted using a fixed dose method (Tortajada, 1995). Wistar rats were dosed with 2000 mg/kg bw. A preliminary experiment comprising one female showed no mortality. Soft faeces were noted on the day following treatment. No other clinical signs were noted during the seven day observation period. A main experiment comprised five animals/sex. Soft faeces were noted on the day following treatment. There were no other clinical signs, mortality or post mortem observations. Body weight gain was normal. The overall conclusion of the study was that the test material showed no significant signs of toxicity.
Although not required for this endpoint, a supporting acute oral toxicity study with the read-across (analogue) substance [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts]; this study also reports an acute oral LD50 of >2000 mg/kg bw.
Acute inhalation toxicity
A waiver is provided for acute inhalation toxicity based on exposure considerations.
Acute dermal toxicity
An acute dermal toxicity study with cocamidopropyl hydroxysultaine, as a 36.2% solution (Mackam CBS-50GE) was conduced in Sprague-Dawley rats. The test article was applied as a single dose under a semi-occlusive dressing for 24 hours. One group of 5 rats per sex received a dose of 2000 mg active ingredient/kg bw. No mortality was observed. No clinical signs indicative of systemic toxicity were observed. Very slight or well defined erythema was noted at the application site for 2 females on day 2. Mean bodyweight gain was slightly lower than historical control data for females over the observation period, notably during the first week following application. However, no such changes were observed for males. Enlargement of the spleen was found in all treated animals but was considered incidental as it is part of the normal background in untreated rats of these strain and age. The dermal LD50 in rats was therefore higher than 2000 mg active ingredient/kg bw.
Justification for classification or non-classification
No classification for acute oral or dermal toxicity is required, based on the results of the available acute oral and acute dermal toxicity studies.
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.
