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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin:
The skin irritation study is performed according to OECD Guideline 404 under GLP. Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin.
Eye:
The eye irritation study is performed according to OECD Guideline 405 under GLP. The test item is considered to be "not irritating" to the rabbit eye.
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:
- From December 12, 2007 to December 26, 2007
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test material name in the study: PF-03394197-11
Lot Number: LCY33580119667 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: Approximately 4 months
- Weight at study initiation: Male: 2.78 and 2.95 kg
- Housing: Individual Stainless Steel Suspended Cages with deotized paper.
- Diet (e.g. ad libitum): Lab Diet® Certified Rabbit Diet # 5322, PMI Nutrition International, Inc. Animals were fasted on the day of arrival, and then food was increased in 25-g increments over
5 to 7 days until feeding was 125 g per day.
- Water (e.g. ad libitum): Automatic watering system, Ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61 to 72°F
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for approximately 12 hours per day. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal trunk of each animal
- % coverage:
- Type of wrap if used: The application site was wrapped with gauze bandaging and non-irritating, semi-occlusive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the wrappings were removed and the residual test substance was removed. Any residual test substance was removed using tepid tap water and a WypAll®.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) The test site was scored for erythema/eschar and edema within 30 to 60 minutes and at 24, 48, and 72 hours following patch removal (postdose).
SCORING SYSTEM:
- Method of calculation: Draize scale for scoring skin irritation. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No erythema or edema was present at any time point in any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin.
- Executive summary:
The skin irritation study is performed according to OECD Guideline 404 under GLP. Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin.
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:
- From 11-May-2009 to 26-May-2009
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test material name in the study: PF-03394197-00
Batch Number: JFB80003
Purity: 97.17% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France, Z1 Le Malcourlet, 03800 Gannat / France
- Age at study initiation: 17 weeks (male), 15 weeks (females)
- Weight at study initiation: 2697 g (male), 2582 - 3124 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf ad libitum.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g (per animal)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for
each animal for corneal opacity, iris, redness and cherna sis of the conjunctivae, separately. The
individual mean scores for corneal opacity and iris were 0.00 for all three animals. The
individual mean scores for the conjunctival reddening were 0.67, 0.33 and 0.67, respectively.
The individual mean scores for the conjunctival swelling was 0.00 for each of the three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the
measurement intervals. Slight reddening of both the conjunctivae and the sclerae were observed
in all three animals at the 1 hour observation after instillation. The reddening of the conjunctivae
persisted up to the 24-hour (one female) or the 48-hour (one male, one female) observation after
application.
The reddening of the sclerae persisted up to the 72-hour observation after treatment in one male
and one female. Slight ocular discharge was present at the 1 hour observations after
administration in two females.
No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the
end of the observation period for all animals. - Other effects:
- No mortality occurred.
No clinical signs were observed during the course of the study.
The body weights of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered to be "not irritating" to the rabbit eye.
- Executive summary:
The eye irritation study is performed according to OECD Guideline 405 under GLP. The test item is considered to be "not irritating" to the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation / corrosion:
In vivo skin irritation, key study, OECD 404:
Mean score for erythema at 24, 48, 72 h for 3 tested animals: 0, 0, 0
Mean score for edema at 24, 48, 72 h for 3 tested animals: 0, 0, 0
According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.
Eye irritation:
In vivo eye irritation, key study, OECD 405:
Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:
cornea opacity: 0, 0, 0;
iris: 0, 0, 0;
conjunctivae: 0.67, 0.33, 0.67;
chemosis: 0, 0, 0.
According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for this endpoint.
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.
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