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EC number: 294-415-6 | CAS number: 91722-14-4
- 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 test substance did not show skin and eye irritancy in two well-conducted in vivo studies.
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:
- January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted according to OECD guideline No. 404 and under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Albino rabbits of stiock Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Number of animals:
- Three female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: an area of 10 x 10 cm was clipped and divided into four fiels. The two anterior fields were used for testing the substance.
- Type of wrap if used: to each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the test substance was applied, and the patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely woud around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with mild soap and luke warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Skin readings for erythema/easchar and oedema formation were made 1, 24, 48 and 72 hours as well as 7 days after termination of exposure. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria listed in Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.
- Executive summary:
The primary skin irritant effect of the test substance was investigated according to the method recommended in OECD guideline No. 404 "Acute Dermal Irritation/Corrosion", 1992 and EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.
Three female albino rabbits were exposed to the test substance at two skin site on the back. After 4 hours of exposure the test substance was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7 days after termination of exposure.
Slight to well-defined skin reactions were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for skin irritation. Effects were fully reversible at 7 days after termination of exposure, except some slight scale formation on the skin of one rabbit.
In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted according to OECD guideline No. 405 and under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted test substance - Duration of treatment / exposure:
- The left eye of the rabbit was treated. The right eye remained untreated and served as control. 0.1 ml of the test substance was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second.
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reactions was recorded at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Three female rabbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the first 24 hour reading, fluorescin was instilled. After rinsing with 20 ml 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage.
- Time after start of exposure: 24 hours
SCORING SYSTEM: The eyes were examined at 1, 24, 48 and 72 hours after treatment for possible damage to the corena, iris and conjunctivae.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria listed in Directive 93/21/EEC of 27 April, 1993. the test substance shall not be classified as an eye irritant.
- Executive summary:
The eye irritant effect of the test substance (SAT 981 170) was investigated according to the method recommended in OECD guideline No. 405, "Acute Eye Irritation/Corrosion' and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)".
Three female albino rabbits were exposed to 0.1 ml of the test substance in the left eye. The eyes were examined and the changes were graded according to a numerical scale at 1, 24, 48 and 72 hours after dosing. Very slight signs of eye irritation were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for eye irritation. Effects were fully reversible 72 hours after exposure.
In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the available information. the test substance did not show skin and eye irritancy in two well-conducted in vivo studies. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for selection of skin irritation / corrosion endpoint:
There is only in vivo skin irriation study available. This study has been conducted according to OECD guideline no. 404 and under GLP.
Justification for selection of eye irritation endpoint:
There is only in vivo eye irriation study available. This study has been conducted according to OECD guideline no. 405 and under GLP.
Justification for classification or non-classification
The test substance did not show skin and eye irritancy in two well-conducted in vivo studies. Therefore, there is no need to classifiy the substance for skin- or eye irritancy, according to the Regulation 1271/2008 and the Directive 67/548/EEC.
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