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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted in 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig maximization study is available, an additional LLNA is not necessary
Test material
- Reference substance name:
- 4,6-bis(octylthiomethyl)-o-cresol
- EC Number:
- 402-860-6
- EC Name:
- 4,6-bis(octylthiomethyl)-o-cresol
- Cas Number:
- 110553-27-0
- Molecular formula:
- C25 H44 O S2
- IUPAC Name:
- 2-methyl-4,6-bis[(octylsulfanyl)methyl]phenol
- Details on test material:
- - Physical state: viscous liquid
- Apperance: yellow, clear
- Storage: at minimum of 19 °C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo (Les Oncins - 69210 L'Arbresle - France), Bantin and Kingman (Aldbrough Hull - HU 11 1QE - Great Britain), David Hall (Burton on Trent - DE 13 8RJ - Great Britain), Shamrock Bloservcles (12, route de Saint Come - 7895C Garabals - France)
- Age at study initiation: no data
- Weight at study initiation: 330-500 g
- Housing: in groups of 5 (or of 2 for the preliminary studies) in polystyrene cages
- Diet: ad libitum; Guinea-pig complete pelleted maintenance food (Extra Labo formule "C.15.50" - Ets. Pletrement, Sainte Colorabe - 77650 Longueville, France).
- Water: ad libitum; softened and filtered drinking water (15 µl) (automatic watering system). Bacteriological and chemical controls were performed every six months
- Acclimation period: at least 5 days
- Rationale for choice: the guinea-pig is the most sensitive species for the evaluation of the allergenic potential. Historically, this species is often used a lot for this type of studies and is the species of choice of the various regulatory authorities.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 -70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Vaseline Codex: lot 653 (Laboratoires Aguettant - 1 avenue Carteret, Lyon - France)
- Concentration / amount:
- 100%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline Codex: lot 653 (Laboratoires Aguettant - 1 avenue Carteret, Lyon - France)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline Codex: lot 653 (Laboratoires Aguettant - 1 avenue Carteret, Lyon - France)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: total of 12 animals (2 males + 2 females)/intradermal induction, topical induction and challenge
Test group : 10 males + 10 females. An additional 1 male and 1 female were treated as satellites to allow for possible non treatment-related mortality
Control group: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS
Intradermal Injection
- Number of animals: 2 male + 2 females
- Concentrations: 10 and 50% in Vaseline codex or 100%
- Methodology: same as in main study
Epicutaneous induction exposure:
- Number of animals: 2 male + 2 females
- Concentrations: 50% in Vaseline codex and 100%
- Methodology: same as in main study
- Evaluation (hr after removal of patch): 1 hour
Challenge
- Site/area: Back/ 8 cm2
- Number of animals: 2 male + 2 females
- Concentrations: 50% in Vaseline codex and 100%
- Method: same as in main study
- Evaluation (hr after removal of patch): 24 and 48
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection
- Site/Area: Back (scapular region)/2 x 4 cm
- No. of injections/animal: 6 injections in pairs each.
- Test substance group: Freund's complete adjuvant blended (1:1, v/v) in 0.9 % NaCl
- Test substance group: undiluted test article
- Test substance group: Freund's complete adjuvant blended (1:1, v/v) in 0.9 % NaCl + undiluted test article
- Control group : Freund's complete adjuvant blended (1:1, v/v) with 0.9 % NaCl
- Control group: Vehicle.
- Control group : Freund's complete adjuvant blended (1:1, v/v) with 0.9 % NaCl + vehicle
- Volume per injection: 0.1 ml/animal
- Evaluation (hr after injection): 24 and 48
Epicutaneous induction exposure:
- Time schedule: 8 days after intradermal induction
- Site: same as intradermal injections (site was pretreated 24 hours before with 0.5 ml per site of 10% w/w sodium lauryl sulphate in Vaseline codex paraffin)
- Area of application: 2 x 4 cm
- Concentrations: undiluted test article (test group), and vehicle (control group)
- Volume applied: 0.5ml/animal
- Type of coverage: occlusive (a 3 x 5 cm waterproof and hypoallergenic adhesive plaster (Blenderm: 3M, Laboratoire des Professions Hedlcales - 10, rue Gabriel Crle - 92210 Malakoff - France). Reinforcement was performed with 4 cm wide linen adhesive tapes applied on hydrophilic gauze
- Duration: 48 hours
- Evaluation (hr after challenge): directly after removal of patch
B. CHALLENGE EXPOSURE (identical treatment for treated and control animals)
- Time schedule: 11 days after end of topical induction
- Site: left flank (test article) and right flank (vehicle)
- Area of application: 2 x 2 cm
- Concentrations: undiluted
- Volume applied: 0.5 ml/animal
- Type of coverage: occlusive (hypoallergenic adhesive plaster (H-IFT - Urgo : Laboratoire de Pansements et d'Hygiene - 42, rue de Longvic - 21300 Chenove - France). Reinforcement was performed with 4 cm wide linen adhesive tapes applied on hydrophilic gauze
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure. Histopathological examination of the skin was performed for all the animals which showed doubtful reactions after macroscopical examination at 24 and 48 hours. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the test was evaluated in the test laboratory with known sensitizers as well as known non sensitizers (Dihydrocoumarin, Paraphenylenediamine, Formalin, Penicillin G, Benzocaine, Propylene Glycol).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 20
Any other information on results incl. tables
PRELIMINARY TEST
Intradermal induction:
At the 24 hour observation time point, the intradermal injection of the undiluted test article (erythema score = 2 (2/4 animals); erythema score = 1 (2/4 animals)) as well as 50% in vaseline (erythema score = 1 (3/4 animals); erythema score = 2 (1/4 animals) caused slight to moderate skin irritations in 4 guinea pigs. At the 48 hour observation point, the intradermal injection of the undiluted test article (erythema score = 2 (4/4 animals) as well as 50% in vaseline (erythema score = 1 (4/4 animals)) caused slight to moderate skin irritations in 4 guinea pigs. A slight skin irritation (erythema score = 1) was seen in only 1/4 guinea pigs at the 24 hour observation time with 10% of the test article in vaseline.
Topical induction:
Only one out of 4 treated animals had a slight erythema after treatment with the undiluted test article (erythema score = 1) or with 50% test article in vaseline (erythema score = 1).
Challenge
No skin irritation was recorded in all 4 animals. On the basis of these results, the undiluted test substance was applied in the main study.
MAIN STUDY
In the control animals, slight desquamation was seen in 4/19 surviving animals at the 48 hour examination following challenge exposures. One female guinea pig died. There was slight desquamation at the site application in the dead control animal. In the treatment group, slight desquamation was evident in 8/20 animals at the 48 hour examination. At the 24 hour examination, no desquamation was seen in any animals, however, 5/20 guinea pigs had an erythema score of 1. At the 48 hour examination, 5 additional guinea pigs had an erythema score of 1. Histopathological biopsies of the cutaneous tissues confirmed a positive skin irritation only in 2 of the10 questionable cases making a total of 2/20 animals (5%) positive for "delayed hypersensitivity". Two cases of mortality were recorded in the treatment group. These animals were replaced with the satellite animals which had undergone simultaneous identical treatment.
POSITIVE CONTROL
The sensitivity of this method was evaluated in the test laboratory using various substances known for their sensitizing potential (or their innocuity). The results obtained are presented in the following table:
Table 1: List of substances tested in the laboratory
Test substance |
Results with Histology (% of sensitized animals) |
Dihydrocoumarin |
100 |
Paraphenylenediamine |
55 |
Formalin |
70 |
Penicillin G |
70 |
Benzocaine |
45 |
Propylene Glycol |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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