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EC number: 941-481-5 | 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
skin irritation, rabbit, semiocclusive, not irritating
eye irritation, rabbits, irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute 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: Kleintierfarm Madörin AG, 4414 Füllingsdorf, CH
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.6 to 2.7 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet: ad libitum; pelleted standard Kliba 341, batch 30/87 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hr
- Photoperiod (hrs dark / hrs light):12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- - Amount applied: 0.5 g solid
- Duration of treatment / exposure:
- 4h
- Observation period:
- 24, 48 and 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Shaved area: 100 cm² (10 cm x 10 cm)
- Area of exposure: 9 cm² (3 cm x 3 cm)
- Location: dorsal
- Type of wrap if used: surgical gauze
REMOVAL OF TEST SUBSTANCE
- Semi-occlusive dressing
- Test item removed and washed with lukewarm tap water 4 hours after application
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after application - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- No irritative response was detected based on erythem and edema score
No corrosion was observed - Other effects:
- In the area of application slight black staining of the treated skin by pigment or colouring of the test item was observed after 1 hour in 2 rabbits. No rabbits demonstrated discolouration after 24 hours.
BODY WEIGHTS
- The body weight gain of all rabbits was similar.
TOXIC SYMPTOMS / MORTALITY
- No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
NECROPSY
- Due to the results obtained, no macroscopic organ examination was indicated. - Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The substance was tested for skin irritation/corrosion following OECD 404. Under the experimental conditions the substance did not show any skin irritant or corrosive properties.
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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed on analogue substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madörin AG, 4414 Füllinsdorf, CH
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.5 to 2.6 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet: ad libitum; pelleted standard Kliba 341, batch 30/87 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: 4 days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT
- The test item was placed in the conjunctival sacs of the left eye of each animal after gently pulling the lower lid away from the eye ball. The lids were then gently held together for about 1 second to prevent loss of the test item.
REMOVAL OF TEST SUBSTANCE :
- Washing: no washing
TOOL USED TO ASSESS SCORE:
- Eye examinations were made with a slit-lamp 30 SL (C. Zelss AG, Zürich, CH) and a "Varta Cliptrix" diagnostic-lamp (A. Riegger, Basel, CH) - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- only slight cornea opacity was observed within 1h to 7 days
- Other effects:
- TOXICITY
- No acute toxic symptoms were observed in the animals during the test period.
MORTALITY
- No mortality occurred.
COLOURATION
- In the area of applicatlon a slight black to black staining of the cornea, lidhairs and conjunctivae by pigment or colouring of the test item was observed.
BODY WEIGHTS
- The body weight gains of all rabbits was similar.
NECROPSY
- No macroscopic organ examination was performed. - Interpretation of results:
- other: classified as H319 Eye Irritation 2
- Conclusions:
- The substance was tested for eye irriation properties following OECD 405. Under the experimental conditions the cornal opacity resulted equal to 1 for 3/3 animals which classified the substance as H319: Causes serious eye irriation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The analogue substance was tested in two in-vivo studies for skin and eye irritation folloiwng EU Method B4 and B5 (1989).
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:
Skin irritant cat2:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; o
3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Eye irritant Cat 2:
at least in 2 of 3 tested animals, a positive response of:
1) corneal opacity ≥ 1 and/or
2) iritis ≥ 1, and/or
3) conjunctival redness ≥ 2 and/or
4) conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Based on the results of the in vivo eye irritation, the substance is classified as H319, Eye Irritation 2.
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