Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 404-800-4 | CAS number: 118832-72-7 IRGANOX L 118
- 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 is not irritating or corrosive to the rabbit skin. The test substance is not irritating to the rabbits eye.
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:
- 1988-03-01 to 1988-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
- 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 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2110 to 2610g
- Housing: Individually in metal cages
- Diet: Standard rabbit pellet, Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral flank of each rabbit served as control (control gauze patch)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the test item - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 days
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approx. 36 cm2 on flanks of the animals
- Type of wrap: the patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place by an adhesive tape (Isoplast)
SCORING SYSTEM: OECD scoring system - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed minimal signs of edema, reversible within 72 hours. The other two animals did not show any signs of irritation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritant to the rabbit skin under the conditions of this study.
- Executive summary:
An acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance (described in section 1.2) on the albino rat skin. This test was based on the OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 mL of the test article was applied to the flank of each animal and held in place for 4 hours by an adhesive tape. A control gauze patch was applied to the contralateral flank. Because slight reactions were observed within 72 hours after dermal application of the test article, the observation period was extended to 7 days to determine the reversibility of the skin reactions. Only minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed a minimal edema, reversible within 72 hours. The other two animals did not show any signs of irritation. Based on the study results, the test item was found to be not irritating to the rabbit skin.
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:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- 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 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2330 to 2430g
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1mL of the test substance - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hrs
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- 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 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Mild conjunctival redness and chemosis were observed in all three animals. These effects reverted back to normal within 48 hours. No other signs of irritation were reported.
- Other effects:
- A slight loss of weight was observed in animal on day 3 (considered not to be treatment - related).
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritating to the rabbit eye under the conditions of this study.
- Executive summary:
An acute eye irritation/corrosion study in New Zealand white rabbits was performed to determine the irritant or corrosive potency of the test item (described in section 1.2). The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal eye conditions. 0.1 mL of the test item 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 article. The animals were checked daily for systemic symptoms and mortality. A slit-lamp was used to facilitate the evaluation. The mean values of the Draize scores at 24, 48 and 72 hrs after application were 1/0/0 for redness and 0/0/0 for chemosis of the conjunctiva. No effects were seen on the opacity of the cornea and on the iris. The test item was no eye irritant under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
A GLP-compliant acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance on the albino rabbit skin. This test was based on OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 mL of the test article was applied to the flank of each animal and held in place for 4 hours by an adhesive tape. A control gauze patch was applied to the contralateral flank. Minimal erythema reaction (average score of 0.7) was observed in one animal, reversible within 24 hours. The same animal also showed minimal erythema reactions, reversible within 72 hours. The other two animals did not show any signs of irritation (Ciba-Geigy, 1988).
In a second skin irritation study following OECD guideline 401 and compliant with GLP, three New Zealand White rabbits were treated with 0.5 ml of the test substance for 4 hours under semiocclusive conditions and skin reactions were observed for 7 days. Mild erythema and edema were noted in all animals from 1 hour after removal of the gauze patch. All effects were reversible within 7 days in 2 animals. The average scores (24, 48 and 72h) in these animals were 1.3 for erythema and 1.0 for edema. One animal still showed signs of erythema and edema at study termination after 7 days. This effect is expected to have reversed back to normal skin conditions if the observation period would have been extended. The average scores (24, 48 and 72h) were 1.3 for both erythema and edema in this animal. Based on these results, the test item is considered to be not irritating to the rabbit skin (Ciba-Geigy, 1983).
Eye irritation:
A GLP-compliant acute eye irritation/corrosion study in New Zealand white rabbits was performed to determine the irritant or corrosive potency of the test item. The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal eye conditions. 0.1 mL of the test item 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 item. The mean values of the Draize scores at 24, 48 and 72 hrs after application were 1/0/0 for redness and 0/0/0 for chemosis of the conjunctiva. No effects were seen on the opacity of the cornea and on the iris. Based on this result, the test item was classified as not irritant (Ciba-Geigy, 1988).
This was confirmed in a second GLP compliant eye irritation study following OECD guideline 405, where the test article was instilled into the conjunctival sac of three rabbits and the ocular reactions were recorded for 7 days. Mild conjunctival redness and chemosis was observed in all animals from one hour after treatment, reversible within 7 days the latest. Average scores (24, 48 and 72 hours) were 0.56 for both redness and chemosis. Additionally, one animal showed minimal reactions to the cornea and iris one hour after the instillation; these effects were reversible within 24 hours and did not result in any 24-72h scores. Based on these results, the test item is considered to be not irritating to the rabbit eye (Ciba-Geigy, 1983).
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
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC.
Based on the data, the test substance has not to be classified as skin or eye irritant.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.
Based on the data, the test substance has not to be classified as skin or eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.