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EC number: 947-892-6 | 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
The substance is not a skin irritant, neither is it an eye irritant.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
- Specific details on test material used for the study:
- - Name as used in the study report: FAT 60149/A.
- Batch No.: Versuch 124 - 4 + 5 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgaü, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 2 to 3 kg
- Housing: individual in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/14 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Propylene glycol + saline (70:30 parts)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schropfschnapper", Aesculap, Switzerland.
- Gauze patches of 2.5 x 2.5 cm with 0.5 g of the test material were applied to the prepared abraded and intact skin.
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- The dressings were removed after a 24 hour application.
OBSERVATION TIME POINTS
- 24, 48 and 72 hours, 4 and 7 days
SCORING SYSTEM
- Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
- Edema formation was scored on a four point scale (Draize). - Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin
- Interpretation of results:
- GHS criteria not met
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
- Specific details on test material used for the study:
- - Name as used in study report: FAT 60149/A
- Batch No.; Versuch 124 - 4 + 5 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgau, Germany and MADOERIN AG, 4414 Fülllinsdorf, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 2 to 3 kg
- Housing: individual in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/14 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- - In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals (3 male, 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In 3 animals
- Time after start of exposure: In 3 animals 30 seconds after insertion of the test substance
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: results from unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: results from unrinsed eyes
- Irritant / corrosive response data:
- Rinsing the eyes following instillation was of no effect.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
Two in vivo skin irritation studies were conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 “Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
In the first study, six rabbits were exposed to 0.5 g of the test substance for 24 hours under occlusion dissolved (50%) in propylene glycol + saline (70 : 30 parts) (CIBA-GEIGY, 1979). The substance was applied on a shaved area of 2.5 x 2.5 cm. The patches containing the substance were covered with an impermeable material. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. In this study, erythema was not assessable due to intensive staining by the test compound. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). One animal showed very slight erythema (score 1) on the intact skin after 24 hours, which was reversed after 48 hours. The other animals showed no irritation on the intact skin.
In the second study, six rabbits were exposed to 0.5 g of the test substance on five consecutive days (CIBA-GEIGY, 1980). The substance was dissolved in propylene glycol + saline (70 : 30 parts) and applied on the shaved back, using gauze patch of 4 x 5 cm. The patches were covered with an impermeable material. The skin reaction was scored after 24 hours after the first four applications and after 8 hours after the fifth application. The skin reaction was recorded again on days 8, 9 and 10 (recovery period). Body weights were recorded at initiation and day 3 and 5 of the treatment period and at day 8 and 10 of the observation period. No erythema or edema was observed after day 1, three animals showed very slight erythema (score 1) and very slight edema (score 1) after day 2. After day 3, four animals showed very slight erythema and very slight edema and one animal showed slight erythema (score 2) and slight edema (score 2). After 5 days, one animal was given a score 2 for both erythema and edema and the other animals a score 1. The effect progressed into score 2 after 8 days in one animal. No reversal was observed up to day 10. The animals showed decreased body weight during the application period, but clear recovery of the body weight at the end of the observation period.
Eye
Two reliable in vivo eye irritation studies were conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
In the first study, six rabbits received 0.1 g of the test substance in the conjunctival sac of the left eye and the right eye was not treated and served as control (CIBA-GEIGY, 1979). In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7. All three rabbits with unrinsed eyes showed scattered or diffuse opacity of the cornea (score 1) on day 1 and day 2, which was reversed on day 3. The iris was observed to be normal (score 0), while the redness of the conjunctivae was observed to be above normal (score 1) for two of the three animals with unrinsed eyes on day one only and some swelling (chemosis) with score 1 was also seen in these animals on day one.
In the second study, six rabbits received 0.1 g of the test substance in the conjunctival sac of the left eye during 5 consecutive days and the right eye was not treated and served as control (CIBA-GEIGY, 1979). No signs of irritation were observed; all scores for cornea, iris and conjunctivea were 0 throughout the observation period.
Justification for classification or non-classification
Based on the available data, the substance does not have to be classified for skin irritation, nor for eye irritation, according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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