Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 800-182-9 | CAS number: 1426148-68-6
- 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
In a GLP compliant OECD 404 study for skin irritation / corrosion, the registered substance produced only minor dermal responses which were fully reversible. Based on the results, the substance is considered to be not irritating to skin. With respect to eye irritation, the registered substance when tested in a GLP compliant OECD 405 study exhibited slight to moderate signs of irritation, which was fully reversible within 7 days post exposure. Based on the findings, the test material has to be considered as irritating to eyes.
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 -5 month
- Weight at study initiation: 188 - 201 g (male), 167 - 196 g (female)
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per patch
- Concentration (if solution): 100 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100%
- Type of wrap if used: semi-occlusive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hour exposure
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema observed throughout the study
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema observed throughout the study
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- dry-rough skin, dwsquamation of fine and coarse scales
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Flotanol F was not irritating to rabiit skin and is not subject for labelling requirements
- Executive summary:
The primary skin irritation potential of Flotanol F was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL of undiluted test material.The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes, 24, 48 and 72 hours as well as 7 and 14 days after removal of the patches. Erythema and oedema were evaluated numerically according to the score of DRAIZE. From 1 hour up to 72 hours after removal of the patches, slight to moderate erythema were observed in all animals. A slight reddening was still observed in one animal at day 7. Except one slight oedema observed in one animal 48 hours after patch removal, no swellings at any of the readings were observed. 14 days pa.a all signs of ittitation were revesible. Based on the study results, Flotanols F is not subject to labelling requirements with regard to skin irritating effects.
Reference
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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per ey
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours post exposure, every reading with fluorescence testing
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein - Irritation parameter:
- cornea opacity score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no iridial effects observed throughout study period
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animls
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, Flotanol F is considered to be irritating to eyes.
- Executive summary:
The primary eye irritation potential of Flotanol F was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours as well as 7 and 14 days after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From one hour up to 72 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson color. The effects were accompanied by aqueous eye discharge. Additionally, from one hour up to 72 hours slight scattered or diffuse areas of corneal opacity as well as sporadic iridial effects were noted in some animals. 7 days after application all signs of irritation were reversible. Accordingly, the tested Flotanol F is considered to be an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
GLP compliant guideline studies are available for the evaluation of the endpoints skin irritation / corrosion and eye irritation with the pure registered substance. With regard to skin irritation / corrosion, three New Zealand albino rabbits were exposed to 0.5 mL of undiluted test material for 4 hours under semi-occlusive test conditions in accordance with OECD guideline 404. Skin reactions were assessed 30 -60 minutes, 24, 48 and 72 hours as well as 7 and 14 days after removal of the patches. As a result slight to moderate erythema were observed in all animals up to 72 hours. However, except one slight oedema in one animal at the 48 hour reading, no swellings were observed. 14 days p.a. all signs of irritation were reversible.
The primary eye irritation potential of the registered substance was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. The eyes were examined 1, 24, 48 and 72 hours as well as 7 and 14 days after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From one hour up to 72 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson color. The effects were accompanied by aqueous eye discharge. Additionally, from one hour up to 72 hours slight scattered or diffuse areas of corneal opacity as well as sporadic iridial effects were noted in some animals. 7 days after application all signs of irritation were reversible. Based on the study results, the registered substance is considered to be an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
Guideline study according to GLP with a Klimisch rating 1
Justification for selection of eye irritation endpoint:
Guideline study according to GLP with a Klimisch rating 1
Effects on eye irritation: irritating
Justification for classification or non-classification
In a guideline and GLP compliant primary skin irritation/corrosion study, the registered substance produced only slight to moderate skin responses. Based on the individual mean scores for erythema and oedema no classification of the registered substance with regard to skin irritation/corrosion is warranted, neither according to the EU Dangerous Substances Directive 67/548 (DSD) nor according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).
With regard to primary eye irritation, a guideline and GLP compliant study revealed individual mean scores for conjunctivae which are supportive of classifying the registered substance as `R36 - irritating to eyes` according to the criteria of the EU DSD and as `category 2`with `H319 - causes serious eye irritation`.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.