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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 LD50 value derived from the acute oral toxicity study with the test substance is > 2000 mg/kg bw. The dermal LD50 is > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-02-08 to 1988-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 174 to 196 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight
- Housing: Segregated by sex, group-housed (5 animals per cage) in Macrolon cages type 4, with standardized soft wood bedding
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2°C
- Humidity: 55 +/- 10%
- Air changes: 15 air changes/h
- Photoperiod: 12 hour/ day light cycle - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily
Body weight: at start and on days 7 and 14
- Necropsy of survivors performed: yes
The animals were submitted to a gross necropsy at the end of the observation period - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Ruffled fur, dyspnea, hunched posture, and exophthalmos were seen, being common symptoms in acute tests. The animals recovered within 10 days.
- Gross pathology:
- No deviations from normal morphology were found.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
The toxic effects of the test substance (described in section 1.2) in albino rats (Tif: RAI f (SPF)) were investigated in an acute toxicity study according to OECD Guideline 401 and in compliance with GLP. Ten albino rats (5 males and 5 females) were treated with the test item at a dosage level of 2000 mg/kg bw by gastric intubation (gavage). Following the single treatment, the animals were observed for a period of 14 days. A gross necropsy was performed on all animals. There were no deaths. Ruffled fur, hunched posture, exophthalmos and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 10 days. All rats remained healthy and gained weight by day 14 of the study. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 of the test item is greater than 2000 mg/kg bw in male and female rats when orally applied.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-02-04 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 230 to 255 g
- Housing: Segregated by sex, group-housed (5 animals per cage) in Macrolon cages type 4, with standardized soft wood bedding
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2°C
- Humidity: 55 +/- 10%
- Air changes: 15 air changes/h
- Photoperiod: 12 hour/ day light cycle - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back of the rat
- % coverage: 10 % of the body surface
- Type of wrap if used: Gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned with lukewarm water at the end of the exposure period - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily;
Signs and symptoms: daily for 14 days;
Body weight: at start and on days 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Ruffled fur, dyspnea, abnormal body positions, and reduced spontaneous activity were seen, being common symptoms in acute tests. The animals recovered within 7 days.
- Gross pathology:
- No deviations from normal morphology were found.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
The toxic effects of the test substance (described in section 1.2) in albino rats (Tif: RAI f (SPF)) were investigated in an acute dermal toxicity study according to OECD Guideline 402 and in compliance with GLP. Ten albino rats (5 males and 5 females) were treated with the test item at a dosage level of 2000 mg/kg bw. The test substance suspension was evenly dispersed on the skin (10 % of the body surface area). It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hrs the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. A gross necropsy was performed on all animals. There were no deaths. All rats remained healthy and gained weight by day 14 of the study. No irritations were noted on any of the test sites. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 of the test item is greater than 2000 mg/kg bw in male and female rats when topically applied.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral route:
The toxic effects of the test substance in albino rats (Tif: RAI f (SPF)) were investigated in an acute oral toxicity study according to OECD Guideline 401 and following GLP principles. Ten albino rats (5 males and 5 females) were treated with the test item at a dose level of 2000 mg/kg bw by gastric intubation (gavage). Following the single treatment, the animals were observed for a period of 14 days. A gross necropsy was performed on all animals. There were no deaths. Ruffled fur, hunched posture, exophthalmos and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 10 days. All rats remained healthy and gained weight by day 14 of the study. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 of the test item is greater than 2000 mg/kg bw in male and female rats when orally applied (Ciba-Geigy, 1988).
This result is supported by a second acute toxicity study following OECD test guideline 401. Five male and female rats were treated by gavage with the test substance at dose levels of 1000, 2500, 5000 and 7500 mg/kg body weight. No mortalities were observed at 1000 mg/kg. At 2500 mg/kg, 1 male and 1 female animal died. At the next higher dose of 5000 mg/kg, 2 males and 1 female died. All animals died in the high dose at 7500 mg/kg. The LD50 was calculated at 4128 mg/kg bw and 4721 mg/kg bw for males and females, respectively (Ciba-Geigy, 1983).
Inhalation route:
The oral and dermal routes of exposure are assessed by key acute toxicity studies. An additional assessment for the inhalation route is not required according to section 2 of REACH Annex VIII (Regulation 1907/2006/EC).
Dermal route:
The toxic effects of the test substance in albino rats (Tif: RAI f (SPF)) were investigated in a GLP compliant acute dermal toxicity study according to OECD Guideline 402. Ten albino rats (5 males and 5 females) were treated with the test item at a dose level of 2000 mg/kg bw. The test substance suspension was evenly dispersed on the skin (10 % of the body surface area). It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hrs the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. A gross necropsy was performed on all animals. There were no deaths. All rats remained healthy and gained weight by day 14 of the study. No irritations were noted on any of the test sites. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 of the test item is greater than 2000 mg/kg bw in male and female rats when topically applied (Ciba-Geigy, 1988).
Justification for selection of acute toxicity – oral endpoint
GLP-compliant guideline study.
Justification for selection of acute toxicity – dermal 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, classification for acute toxicity is not warranted under Directive 67/548/EEC.
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, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.
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