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EC number: 485-320-2 | CAS number: 221667-31-8
- 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 (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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:
- 02 Nov - 05 Nov 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 Jul 2015
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany
- Age at study initiation: Young adults (actual ages not stated)
- Weight at study initiation: 2.9 kg - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding.
- Diet: Standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, Soest, Germany), approx. 100 g/animal/day, ad libitum.
- Water: Tap water from polycarbonate bottles, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 2004-11-02 To 2004-11-05 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- The pulverized test substance was moistened with Aqua p.i. to ensure good contact with the skin.
- Controls:
- other: untreated dorsolateral skin site of same animal served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- Initial test (1 animal): 3 min, 1 and 4 h.
Confrimatory test (2 animals): 4 h - Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h after patch removal. - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 on the dorsal area of the trunk.
- Type of wrap if used: Gauze patch held in place with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, skin was carefully washed with water.
- Time after start of exposure: Initial test 3 min, 1 and 4 h. Confrimatory test 4 h.
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 h after patch removal.
SCORING SYSTEM:
- Method of calculation: Draize scoring system. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No evidence of skin irritation was observed
- Other effects:
- No treatment-related signs of toxicity.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.
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:
- 21 Jun - 24 Jun 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9 Oct 2017
- Deviations:
- yes
- Remarks:
- No use of analgesics.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany.
- Age at study initiation: Young adults (actual ages not stated)
- Body weight at study initiation: 2.9 - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding, changed at least twice weekly and animals were regularly transferred to clean cages.
- Diet: Approx. 100 g/animal/day standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, 59494 Soest, Germany) .
- Water: Tap water from polycarbonate bottles, ad libitum.
- Acclimatization period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Room temperature: 20 ±3 °C
- Air humidity: 50 ± 25 %
- Air changes (per hr): approx. 10
- Light/ Dark cycle (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2005-06-21 To 2005-06-24 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as control
- Amount / concentration applied:
- - Amount (s) applied: 0.1 g (pulverized test substance).
- Duration of treatment / exposure:
- Single application without washing.
- Observation period (in vivo):
- 72 h
Reading time points: 1,24,48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eye was not rinsed for at least 24 hours following instillation.
SCORING SYSTEM: Draize scoring system. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Conjunctival redness, grade 2 was the only finding 1 h after treatment in all 3 animals. However, reversibility was evident and conjunctival redness grade 1 was observed in all 3 animals at 24 h post-treatment and in one animal only at 48 h. Ocular effects were completely resolved in all animals at 72 h.
- Other effects:
- There was reduced food intake in 2/3 test animals which was considered to be not test substance related by the investigators.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation/corrosion study was performed in accordance with OECD 404 (M-129076-01-1, 2004). The test substance was moistened with water and placed on a gauze patch. The gauze patch was applied to the intact skin of Crl:KBL(NZW)BR albino rabbits under semi-occlusive conditions for exposure periods of 3 min, 1 h or 4 h. After the respective treatment, the gauze patch was removed and the treated skin site was cleaned. Observation of the treated skin sites following 3 min or 1 h exposure was done immediately after patch removal. For the 4 h exposure, the evaluation of irritant effects was performed at 1, 24, 48 and 72 h after patch removal. There were no signs of skin irritation or corrosion at the treated skin sites. All scores at any observation time points were 0. Under the test conditions, the test substance was not irritating to the skin.
The eye irritation study was performed in accordance with OECD 405 (M-258984-01-1, 2005). The unchanged test substance was applied in the conjunctival sac of one eye of each Crl:KBL(NZW)BR albino rabbit, the untreated eye served as the control. 1, 24, 48 and 72 h after test substance instillation, the grades of ocular reaction (conjunctivae, cornea, iris) were recorded. Conjunctival redness (score 1-2) was observed in all three animals, but was fully reversible within 48 h post application in two animals. The third animal recovered within 72 h post application. No other eye irritation effects were noted. Under the test conditions, the test substance was not irritating to the eyes.
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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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