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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 442-640-7 | CAS number: -
- 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
A skin irritation study in rabbits was performed according to OECD 404 and EU Method B.4 following GLP guidelines. An eye irritation study in rabbits was performed in one animal according to OECD 405 and EU Method B.5 following GLP guidelines. The test compound caused irreversible discolorations in the eye of the animal. This is not considered an adverse effect but substance specific staining.
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:
- 2001-12-03 to 2002-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.1 - 3.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations took place after 30 - 60 minutes, 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was carefully removed from the skin with warm tap water
- Time after start of exposure: following exposure period
SCORING SYSTEM: DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: <= 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: <= 0 (related to all animals)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Reactive Olive F00-0149 is not irritation to the skin based on results from a rabbit skin irritation test according to OECD 404.
- Executive summary:
In a primary dermal irritation study, 3 rabbits weighing 3.1 -3.5 kg, were dermally exposed to 500 mg Reactive Olive F00-0149 in deionized water to 25 cm2 dorsal region skin. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days. Irritation was scored by the DRAIZE method.
In this study, Reactive Olive F00-0149 is not a dermal irritant.
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:
- 2002-01-14 to 2002-03-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, only one animal tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration of the test substance
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after administration the treated eye was washed out thoroughly with isotonic saline at approx. 37 °C. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
SCORING SYSTEM:
-Cornea: opacity (0-4), affected area (0-4)
-Iris (0-2)
-Conjunctivae: redness (0-3,9), chemosis (0-4), discharge (0-3) - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0.33
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information discolouration of the eye is considered a dye specific effect Criteria used for interpretation of results: expert judgment
- Conclusions:
- The applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.
- Executive summary:
In a primary eye irritation study, 100 mg of Reactive Olive F00 -0149 was instilled into the conjunctival sac of the left eye of 1 New Zealand White rabbit for 24 hours. The treated eye was washed out thoroughly with isotonic saline at approx. 37 °C after 24 hours. Additionally, the eye was washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed. The animal was then observed for 3 days. Irritation was scored by the method described by Draize.
From one hour up to one day after application the conjunctiva of the animal showed injected blood vessels up to a diffuse crimson red color and swelling with partial eversion of the lid. Additionally, there was presence of a clear substance colored (green) eye discharge. 2 days after application the irritations had disappeared. Nictitating membrane and conjunctiva were green discolored from day 2 up to the end of the study. Redness and chemois of the conjunctiva received a score of 0.67 and 0.33, respectively, while the corneal opacity and iris scores were 0.
In this study, Reactive Olive F00-0149 would be an eye irritant based on persistent discoloration. However, the applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.
Reference
1 hour after the 72-hour injection a light redding of the conjunctiva was observed. 1 hour after the 24-hour injection
a light swelling occured. Clear green outflow. 2 days pa all signs of the swelling were disappeared.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study, rabbits were dermally exposed to 500 mg Reaktiv Oliv F00-0149 in deionized water to 25 cm2 dorsal region skin. Test sites were covered with a semi-occlusive dressing for 4 hours and then observed for 14 days. Irritation scores for edema and erythema were both 0 indicating Reaktiv Oliv F00-0149 is not a dermal irritant.
In a primary eye irritation study, 100mg of Reaktiv Oliv F00 -0149 was instilled into the conjunctival sac of the left eye of one New Zealand White rabbit for 24 hours and observed for 3 days. The test compound caused irreversible discolorations in the eye of the animal. This is not considered an adverse effect but substance specific staining. Redness and chemois of the conjunctiva received a score of 0.67 and 0.33, respectively, while the corneal opacity and iris scores were 0.
Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study
Justification for selection of eye irritation endpoint:
GLP guideline study
Justification for classification or non-classification
No adverse effects have been reported in a primary dermal irritation study.
In a primary eye irritation study the test compound caused irreversible discolorations in the eye of the animal. This is not considered an adverse effect but substance specific staining.
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.