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EC number: 262-634-6 | CAS number: 61167-58-6
- 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): not irritant
Eye irritation (rabbit): not 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
- Study period:
- 30 Aug - 10 Sep 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The test method used is in fact the Draize test method.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sumilizer GM
- Analytical purity: >99% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Shizuoka, Japan
- Weight at study initiation: 2.74 - 3.19 kg
- Housing: in fixing boxes during treatment period
- Diet, CG-3 type (Clea Japan Inc., Osaka, Japan), approx. 100 g/day
- Water: ad libitum, except for a period of 24 h after application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10 - Type of coverage:
- occlusive
- Preparation of test site:
- other:
- Remarks:
- clipped and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with physiological saline - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: skin of the back
- Type of wrap if used: The test material was applied to 1 inch square lint patches The patches were held in place with an occlusive tape (Blenderm, surgical tape, 3M Co.).
REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was wiped to remove remaining test substance.
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
24, 48 and 72 h and 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reaction was observed on abraded and clipped skin.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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:
- 10 Feb - 28 Mar 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- yes
- Remarks:
- no topical anesthetics and systemic analgesics were used; no initial test was performed
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nihon Dobutsu Co., Osaka, Japan
- Weight at study initiation: 2.35 - 2.68 kg
- Diet: CG-3 type (Clea Japan Inc., Osaka, Japan), 100 g/day
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- Group 1: Single application without washing
Group 2: 30 s - Observation period (in vivo):
- 1, 24, 48, 72 and 96 h and 7 days
- Number of animals or in vitro replicates:
- 6 (Group 1) and 3 (Group 2)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of the animals in Group 2 were rinsed with lukewarm water
- Time after start of exposure: 30 s (Group 2); the treated eye remained unwashed following the instillation (Group 1)
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- 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: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritant / corrosive response data:
- All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritancy potential of the test substance (CAS 61167-58-6) was determined in a skin irritation study performed similar to OECD guideline 404 (Laboratory of Biochemistry and Toxicology Research, 1982). The test substance was topically applied to the clipped skin of three male and three female rabbits (NZW) for 24 h. Local reactions were scored at 24, 48 and 72 h and 7 days using the Draize scheme after substance application. No skin irritant reactions were observed in all animals (graded with score 0 for erythema and edema) at 24, 48 and 72 h and at 7 days reading time points. Based on the results of the conducted study, the test substance (CAS 61167-58-6) is not considered to exhibit irritating properties towards the skin.
Eye irritation
To evaluate the irritation potential of the test substance (CAS 61167-58-6) towards the eyes, an in vivo study performed similar to OECD guideline 405 was evaluated. In this study, 100 mg (unchanged) of the test substance was instilled into the eyes of 9 white rabbits (NZW) (Laboratory of Biochemistry and Toxicology Research, 1982). In Group 1, comprising 6 animals, the treated eyes remained unwashed. The eyes of the 3 animals of Group 2 were rinsed 30 s after the application of the test substance with lukewarm water. The eyes were examined 1, 24, 48, 72, 96 and 168 h after treatment. Scoring of eye findings was done according to the Draize scoring system. All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively. Based on the results of the conducted study, the substance (CAS 61167-58-6) is considered as not irritating towards the eyes.
Justification for classification or non-classification
The available data on skin and eye irritation / corrosion with the test substance (CAS 61167-58-6) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
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