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EC number: 829-608-1 | CAS number: 106396-29-6
- 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:
The study was performed in accordance with OECD Guideline for the testing of chemicals: Acute Dermal Irritation/Corrosion (TG 404, adopted July 28, 2015). The test substance was considered to have no irritations to skin in rabbits.
Eye irritation:
The study was performed in accordance with the OECD Guideline for the testing of chemicals: Acute Eye Irritation/Corrosion (TG 405, adopted October 9, 2017). The test subatnce could produce very slight eye irritant reactions in rabbit.
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:
- From 2018-06-21 to 2018-06-25
- 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:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Purity: > 99%
Batch No.: 102Z4 - Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at arrival and 90 - 91 days at dosing
- Weight at study initiation: 2112.3-2486.1 g at dosing
- Housing: in stainless steel cages (W 70 cm × L 80 cm × H 75 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 -7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ultra-purified water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: elastic bandage and medical paper tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was gently wiped off the application site by cotton moistened with tepid water.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Clinical Observations: once daily throughout the study
- Skin Reactions Examination: at approximate 1, 24, 48 and 72 hours after patches removal
- Body Weights: within 24 hours after arrival, on the day of dosing and on the completion of the final observations of dermal irritation symptoms
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- mean of three males
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- mean of three males
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to have no irritations to skin in rabbits.
- Executive summary:
The study was performed to assess the acute dermal irritation/corrosion of the test substance in Japanese White rabbits in accordance with OECD Guideline for the testing of chemicals: Acute Dermal Irritation/Corrosion (TG 404, adopted July 28, 2015).
Three male rabbits were used for the study. A quantity of 0.5 g test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control. Clinical signs were performed once daily throughout the study. The skin sites of each animal for signs of erythema/eschar and oedema were all recorded immediately, and at approximate 1, 24, 48 and 72 hours after patch removal, and all local toxic effects of skin were also fully described and recorded. Individual animal body weights were recorded on the day of dosing and on the completion of final observations of dermal irritation symptoms.
No abnormal signs or symptoms were observed in all animals throughout the course of the study. There were no observable abnormalities for three control sites in skin reaction examinations at all observation intervals after patches removal. There were no observable abnormalities for three test sites in skin reaction examinations at approximate 1, 24, 48 and 72 hours after patches removal of the test item. All animals showed expected gains in body weights during the course of the study.
Based on above results, the test substance was considered to have no irritations to skins in rabbits, and was classified as unclassified according to GHS's classification criteria for the skin irritation.
Reference
Inidividual skin reactions grading:
Animal ID | Skin reactions | 1 h | 24 h | 48 h | 72 h |
1100 | Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
1101 | Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema |
0 | 0 |
0 | 0 | |
1102 |
Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 |
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:
- From 2018-06-21 to 2018-06-28
- 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:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Purity: > 99%
Batch No.: 102Z4 - Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at receipt and 90 - 94 days at dosing
- Weight at study initiation: 1899.2 - 2009.1 g at receipt and 2233.4 - 2257.5 g at dosing
- Housing: in stainless wire cages (W 70 cm × L 80 cm × H 75 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 – 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Details on study design:
- TOOL USED TO ASSESS SCORE: binocular loupe
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- probability of weak irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively. The maximum values of animals No. 1100 and 1102 are 1, 1.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Other effects:
- - Clinical Observations: No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing.
- Eye Examination: There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration.
- Fluorescein Examination: There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing.
- Body Weights: All animals showed expected gains in body weights during the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test subatnce could produce very slight eye irritant reactions in rabbit.
- Executive summary:
The study was performed to assess the acute eye irritation/corrosion of the test substance in Japanese White rabbits in accordance with the OECD Guideline for the testing of chemicals: Acute Eye Irritation/Corrosion (TG 405, adopted October 9, 2017).
Three male rabbits were used for the study. Each animal was administered with 0.1 g of the test item into the right eye. Untreated left eye served as the control. Immediately after administration of the test item, the initial reaction was observed and recorded. Test animals were routinely observed and recorded for clinical signs of pain and/or distress and any adverse systemic effects except eye twice daily for 3 days after administration of the test item, with a minimum of 6 hours between observations. Both eyes of animals were examined by a binocular loupe at approximate 1, 24, 48 and 72 hours after administration. The ocular reactions and any other lesions in the eye were recorded at each examination. Fluorescein stain examination was used at approximate 24 hours after administration. Ocular lesions (cornea, iris, conjunctivae redness and chemosis) for treated eye of each animal were scored and recorded at each examination. Mean scores of ocular lesions at approximate 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded on the day of dosing and the completion of the final symptom observations of eye irritation.
No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing. There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration. There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing. Body Weights: All animals showed expected gains in body weights during the study.
Based on above results, the test substance could produce very slight eye irritant reactions in rabbit, and was classified as unclassified according to GHS's classification criteria for the eye irritation.
Reference
Eye reaction scoring:
Animal ID | Eye reactions | 1 h | 24 h | 48 h | 72 h |
1100 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 1 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 | |
1101 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 0 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 | |
1102 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 1 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The study was performed to assess the acute dermal irritation/corrosion of the test substance in Japanese White rabbits in accordance with OECD Guideline for the testing of chemicals: Acute Dermal Irritation/Corrosion (TG 404, adopted July 28, 2015).
Three male rabbits were used for the study. A quantity of 0.5 g test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control. Clinical signs were performed once daily throughout the study. The skin sites of each animal for signs of erythema/eschar and oedema were all recorded immediately, and at approximate 1, 24, 48 and 72 hours after patch removal, and all local toxic effects of skin were also fully described and recorded. Individual animal body weights were recorded on the day of dosing and on the completion of final observations of dermal irritation symptoms.
No abnormal signs or symptoms were observed in all animals throughout the course of the study. There were no observable abnormalities for three control sites in skin reaction examinations at all observation intervals after patches removal. There were no observable abnormalities for three test sites in skin reaction examinations at approximate 1, 24, 48 and 72 hours after patches removal of the test item. All animals showed expected gains in body weights during the course of the study.
Based on above results, the test substance was considered to have no irritations to skins in rabbits, and was classified as unclassified according to GHS's classification criteria for the skin irritation.
Eye irritation:
The study was performed to assess the acute eye irritation/corrosion of the test substance in Japanese White rabbits in accordance with the OECD Guideline for the testing of chemicals: Acute Eye Irritation/Corrosion (TG 405, adopted October 9, 2017).
Three male rabbits were used for the study. Each animal was administered with 0.1 g of the test item into the right eye. Untreated left eye served as the control. Immediately after administration of the test item, the initial reaction was observed and recorded. Test animals were routinely observed and recorded for clinical signs of pain and/or distress and any adverse systemic effects except eye twice daily for 3 days after administration of the test item, with a minimum of 6 hours between observations. Both eyes of animals were examined by a binocular loupe at approximate 1, 24, 48 and 72 hours after administration. The ocular reactions and any other lesions in the eye were recorded at each examination. Fluorescein stain examination was used at approximate 24 hours after administration. Ocular lesions (cornea, iris, conjunctivae redness and chemosis) for treated eye of each animal were scored and recorded at each examination. Mean scores of ocular lesions at approximate 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded on the day of dosing and the completion of the final symptom observations of eye irritation.
No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing. There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration. There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing. Body Weights: All animals showed expected gains in body weights during the study.
Based on above results, the test substance could produce very slight eye irritant reactions in rabbit, and was classified as unclassified according to GHS's classification criteria for the eye irritation.
Justification for classification or non-classification
Skin irritation/corrosion:
Mean scores at 24, 48 & 72 hours for erythema and oedemas were all 0 for 3 test animals.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.2.2, this substance should not be classified forthe Skin irritation/corrosion endpoint.
Serious eye damage/eye irritation:
Mean scores of cornea opacity, iris, conjunctivae redness and conjunctivae chemosis of three treated eyes were all 0 at 24, 48 and 72 hours after administrations.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.3.2, this substance should not be classified for the Serious eye damage/eye irritation endpoint.
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