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EC number: 407-000-3 | CAS number: 127519-17-9 CGL 384; TINUVIN 384
- 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: not irritating, OECD Guideline Study, Ciba-Geigy, 1991
Eye: not irritating, OECD Guideline Study, Ciba-Geigy, 1990
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:
- August 21, 1990 - August 24, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive
- GLP compliance:
- yes
- Remarks:
- Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: approx. 9 - 13 weeks
- Weight at study initiation: 2580 to 2720 g
- Housing: individually in metal cages
- Diet: standard pellet, Nafag No. 814 e.g. ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Control gauze patches moistened with distilled water were applied to the contralateral flanks.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL water
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- Type of wrap if used: gauze patch covered loosley with aluminum foil and held in place by an adhesive tape
SCORING SYSTEM: OECD scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: minimal reactions at the 1 hour mark in one animal
- Irritant / corrosive response data:
- The test substance induced minimal erythema and edema reactions revesible within 48 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article caused minimal dermal reactions below the threshold of significance and is therefore regarded as not irritating to the rabbit skin.
- Executive summary:
In an acute dermal irritation/corrosion study following OECD guideline 404 and in compliance with GLP, three New Zealand White rabbits were exposed to 0.5 ml of the test substance. A gauze patch (approx.12-16 cm) bearing the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with test material. The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Under the experimental conditions employed the test substance induced mild erythema and edema reactions revesible within 48 hours when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance, the test article is considered as not irritating to the rabbit skin.
Reference
Individual Irritation Scores:
Erythema | Edema | ||
1 h | 728 | 1 | 0 |
723 | 1 | 0 | |
706 | 1 | 1 | |
24 h | 728 | 1 | 0 |
723 | 0 | 0 | |
706 | 1 | 0 | |
48 h | 728 | 0 | 0 |
723 | 0 | 0 | |
706 | 0 | 0 | |
72 h | 728 | 0 | 0 |
723 | 0 | 0 | |
706 | 0 | 0 | |
mean 24 - 72 h | 728 | 0.3 | 0.0 |
723 | 0.0 | 0.0 | |
706 | 0.3 | 0.0 | |
mean 24 - 72 h | 0.2 | 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:
- August 28, 1990 - September 7, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study (OECD)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- yes
- Remarks:
- Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: approx. 9 - 13 weeks
- Weight at study initiation: 2290 to 2560 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single instillation, not washed
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 10 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Instillation of the test substance caused minimal corneal irritation in 2/3 animals at the 1-hour timepoint, reversible within 24 hours. Conjunctival effects were redness and chemosis in all three animals; chemosis was reversible after 24 hours and redness after 10 days.
- Other effects:
- No other effects.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions employed the test article induced mild irritation of the cornea and conjunctiva below the threshold of signifcance and is therefore regarded as not irritating to the rabbit eye.
- Executive summary:
In a GLP-compliant eye irritation study performed according to OECD guideline 405, three New Zealand White rabbits were treated with 0.1 ml of the test article. The test article was placed into the conjunctival sac of the left eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The right eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. Because reactions were observed within 72 hours after instillation of the test article, the observation period was extended to 10 days. Instillation of the test substance caused minimal corneal irritation in 2/3 animals at the 1-hour time point, reversible within 24 hours. Conjunctival effects were redness and chemosis in all three animals; chemosis was reversible after 24 hours and redness after 10 days. Since the observed ocular effects were below the threshold of significance, the test article is classified as not irritating.
Reference
Individual Irriation Scores:
Conjunctiva | |||||
Cornea | Iris | Redness | Chemosis | ||
1 h | 245 | 1 | 0 | 2 | 1 |
799 | 1 | 0 | 2 | 1 | |
895 | 0 | 0 | 2 | 1 | |
24 h | 245 | 0 | 0 | 1 | 0 |
799 | 0 | 0 | 1 | 0 | |
895 | 0 | 0 | 1 | 0 | |
48 h | 245 | 0 | 0 | 1 | 0 |
799 | 0 | 0 | 1 | 0 | |
895 | 0 | 0 | 1 | 0 | |
72 h | 245 | 0 | 0 | 1 | 0 |
799 | 0 | 0 | 1 | 0 | |
895 | 0 | 0 | 1 | 0 | |
mean 24 - 72 h | 245 | 0.0 | 0.0 | 1.0 | 0.0 |
799 | 0.0 | 0.0 | 1.0 | 0.0 | |
895 | 0.0 | 0.0 | 1.0 | 0.0 | |
mean 24 - 72 h | 0.0 | 0.0 | 1.0 | 0.0 | |
7 days | 245 | 0 | 0 | 0 | 0 |
799 | 0 | 0 | 1 | 0 | |
895 | 0 | 0 | 1 | 0 | |
10 days | 245 | 0 | 0 | 0 | 0 |
799 | 0 | 0 | 0 | 0 | |
895 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin: In a GLP-compliant primary dermal irritation study (OECD 404, Ciba-Geigy, 904254), 3 female New Zealand White rabbits were dermally exposed to 0.5 mL of the test substance for 4 hours under occlusive conditions. Animals were then observed for 3 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. Minimal dermal reactions were recorded below the threshold of significance. The mean score for the 24, 48 and 72 h reading for erythema was 0.2 and for edema was 0. The skin reactions observed were reversible within 48 days. Based on the results of this study, the test article is regarded as not irritating to the rabbit skin.
Eye: A GLP-compliant eye irritation test was performed with three male New Zealand White rabbits according to OECD 405 (Ciba-Geigy, 904253). Eyes were left unwashed after application of 0.1 mL of test material and the animals were observed 10 days. The mean scores for the 24, 48 and 72 h readings for iritis, cornea opacity and conjunctivae chemosis were 0 at any of this reading time points. For conjunctivae redness the mean score for the 24, 48 and 72 h reading was 1. The eye reactions observed were reversible until the end of the observation period on day 10. In this study, the test substance is not an eye irritant.
Respiratory system: No data available.
Justification for selection of skin irritation / corrosion endpoint:
GLP-compliant guideline study
Justification for selection of eye irritation endpoint:
GLP-compliant guideline study
Justification for classification or non-classification
Skin & Eye
Dangerous Substance Directive (67/548/EEC): The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin and eye irritation under Directive 67/548/EEC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008: The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.
Respiratory system
At present, there are no data available for this endpoint.
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