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EC number: 811-502-1 | CAS number: 73206-60-7
- 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 primary cutaneous irritation index (P.C.I.) was determined to be 1.2, and the test substance was evaluated as “slightly 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:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
- 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: Kitayama Labes Co., Ltd; Kbl: NZW (SPF)
- Age at study initiation: 11 weeks
- Weight at study initiation: 2300 to 2472 g
- Housing: 1 animal per cage, in aluminum cages (W650 × D570 × H413 mm), Stainless-steel cascade rack and feeders; toys were used for improvement of animal welfare
- Diet: pellet diet (RC4, Oriental Yeast Co., Ltd.), ad libitum
- Water: well water admixed with sodium hypochlorite (free residual chlorine concentration: about 0.2 ppm), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 – 23.4
- Humidity (%): 48.5 – 63.8
- Air changes (per hr): 10 – 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- - Initial test: 3 min, 60 min and 4 hours
- Confirmatory test: 4 hours - Number of animals:
- - Initial test: 1
- Confirmatory test: 2 - Details on study design:
- TEST SITE
- Area of exposure: In the initial test three sites (2.5 cm × 2.5 cm each) were created on the shaved area. In the confirmatory test one site of the same size was created.
- Type of wrap if used: The test substance was placed on a 2.5 cm × 2.5 cm patch (lint cloth, Yamato Kojo Co., Ltd.) attached with a 5 cm × 5 cm non-woven adhesive bandage (Mesh-pore®, Nichiban Co., Ltd.) and placed on each application site. The application sites were occluded by an adhesive elastic bandage (Elastopore®, Nichiban Co., Ltd.).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Each occlusion was released and each application site was cleaned with absorbent cotton moisturized with lukewarm water.
- Time after start of exposure: Initial test: 3 minutes, 60 minutes, and 4 hours, confirmatory test: 4 hours
SCORING SYSTEM: The skin conditions of the 3 and 60 minutes application sites (initial test) at 1 hour after patch removal, and those of the 4 hours application site (all animals) at 1, 24, 48, 72 hours and 7 days after patch removal were scored based on the evaluation criteria for erythema and oedema formations to calculated the Primary Cutanous Irritation Index. - Irritation parameter:
- other: primary cutaneous irritation index
- Basis:
- mean
- Time point:
- other: 1 - 48 h
- Score:
- 1.2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The very slight erythema (erythema score 1) was observed in initial test at 3 and 60 minutes application sites at 1 hour after patch removal.
As a result of 4-hour exposure, very slight erythema (erythema score 1) was observed in all animals at 1 hour after patch removal. In addition, well defined erythema (erythema score 2) and very slight oedema (oedema score 1) were observed in one animal at 48 and 72 hours after patch removal. These reactions disappeared from all animals by 7 days after patch removal. Therefore, primary cutaneous irritation index (P.C.I.) was 1.2, and it was evaluated as “slightly irritant”. - Other effects:
- No abnormal clinical signs or body weight gain was observed in any animal
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The primary cutaneous irritation index (P.C.I.) was determined to be 1.2, and the test substance was evaluated as “slightly irritant”.
- Executive summary:
The acute dermal irritation or corrosion potential of the test substance was assessed in a GLP compliant OECD 404 guideline study. The test substance was topically applied to the back skin (2.5 cm x 2.5 cm) of three male New Zealand White rabbits for 4 hours under semi-occlusive conditions. Very slight erythema (erythema score 1) was observed in all animals at 1 hour after patch removal. In addition, well defined erythema (erythema score 2) and very slight oedema (oedema score 1) were observed in one animal at 48 and 72 hours after patch removal. These reactions disappeared from all animals by 7 days after patch removal. Therefore, primary cutaneous irritation index (P.C.I.) was 1.2, and it was evaluated as “slightly irritant”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute dermal irritation or corrosion potential of the test substance was assessed in a GLP compliant OECD 404 guideline study. The test substance was topically applied to the back skin (2.5 cm x 2.5 cm) of three male New Zealand White rabbits for 4 hours under semi-occlusive conditions. Very slight erythema (erythema score 1) was observed in all animals at 1 hour after patch removal. In addition, well defined erythema (erythema score 2) and very slight oedema (oedema score 1) were observed in one animal at 48 and 72 hours after patch removal. These reactions disappeared from all animals by 7 days after patch removal. Therefore, primary cutaneous irritation index (P.C.I.) was 1.2, and it was evaluated as “slightly irritant”.
Justification for selection of skin irritation / corrosion endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Based on the available information classification for skin irritation/corrosion is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
As no study is available for eye irritation, classification for eye irritation is not possible in accordance with 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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