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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
- 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
In a skin irritation study conducted according to the OECD Guideline 404, the test item caused a slight irritation (mean erythema score 1 in 2/3 animals), completely reversible within 7 days after treatment. In an eye irritation study conducted according to the OECD Guideline 405, the test article also caused a very slight irritation reaction (mean conjunctivae score 0.67 in all 3 animals), completely reversible within 72 hours.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Sex: male
- Weight at study initiation: 2070-2110 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for skin irritation/corrosion studies
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contra-lateral flank covered with gauze patch
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours and 7 days after removing the gauze patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: An area of approx. 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
- % coverage: A gauze patch (20 cm2)
- Type of wrap if used: The patches were loosely covered with an aluminium foil (36 cm2 and held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
SCORING SYSTEM: according to the OECD scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin irritation was observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight scaling at the application area was observed in all animals on day 7. On the control flanks, no skin irritation effects were observed in any animal.
- Other effects:
- A slight loss of weight was observed in one animal on day 3 (2090 g versus 2110 g at start of test)
- Interpretation of results:
- GHS criteria not met
Reference
Summary of results:
Animal 1 | Animal 2 | Animal 3 | ||
erythema | 1 h | 0 | 0 | 0 |
24 h | 1 | 0 | 1 | |
48 h | 1 | 0 | 1 | |
72 h | 1 | 0 | 1 | |
7 days | 0 | 0 | 0 | |
edema | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
7 days | 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
- 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 May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Sex: male
- Weight at study initiation: 2060-2170 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (quality of the drinking water met the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for acute eye irritation/corrosion studies
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
The test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second to prevent loss of the test material. - Duration of treatment / exposure:
- eyes were not washed after instillation
- Observation period (in vivo):
- The ocular reactions were evaluated 1, 24, 48, 72 hours and 7 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to the OECD scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Two animals showed minimal edema (score 1) one hour after instillation, reversible within 24 hours. All animals had minimal erythema (score 1) during evaluation time points 1h, 24h and 48 h, reversible within 72 hours. No signs of irritation was seen on the iris and cornea.
- Other effects:
- A slight loss of weight was observed in one animal on day 3 (2110 g versus 2130 g at start of test)
- Interpretation of results:
- GHS criteria not met
Reference
Overview of results:
Animal 1 | Animal 2 | Animal 3 | ||
redness | 1 h | 1 | 1 | 1 |
24 h | 1 | 1 | 1 | |
48 h | 1 | 1 | 1 | |
72 h | 0 | 0 | 0 | |
7 days | 0 | 0 | 0 | |
chemosis | 1 h | 1 | 0 | 1 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
7 days | 0 | 0 | 0 | |
cornea | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
7 days | 0 | 0 | 0 | |
Iris | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
7 days | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a dermal irritation study performed according to the OECD Guideline 404, 0.5 ml unchanged test substance was applied to the shaved skin site of 3 male New Zealand White rabbits for 4 hours under a secured semi-occlusive gauze patch (20 cm²). The untreated contra-lateral flank of the same animals, also covered with gauze patch, was used as control. The skin reaction was observed 1, 24, 48, and 72 hours and 7 days after removing the gauze patch and evaluated according to the OECD scoring system. The only sign of irritation was a slight erythema reaction (mean 24-48-72-hour erythema score 1) observed in 2/3 animals, but fully reversible within 7 days.
Eye irritation
In an ocular irritation study performed according to the OECD Guideline 405, 0.1 ml unchanged test substance was applied to the conjunctival sac of each one eye of 3 male New Zealand White rabbits (no wash out) while the remaining untreated one served as negative control. The ocular reactions were then evaluated 1, 24, 48, 72 hours and 7 days after instillation according to the OECD scoring system, and the body weight was recorded at start and on days 3 and 7 of the test. The animals were also checked daily for systemic symptoms and mortality. The only sign of ocular irritation was a slight conjunctival reaction (mean 24-48-72-hour conjunctiva score of 0.67) observed in all treated eyes, but was fully reversible within 72 hours after treatment.
Respiratory irritation
No data available
Justification for classification or non-classification
Based on the results of the valid skin and eye irritation studies, there is no need for classification of the test substance for skin or eye irritation according to the CLP Regulation (EU) 1272/2008.
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