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EC number: 500-281-4 | CAS number: 98362-33-5
- 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
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is slightly irritating to the skin of rabbits (OECD 404, Hüls 1985) and not irritating to eye and mucosa of rabbits (OECD 405, Hüls 1985), which does not meet the criteria according to EC regulation 1272/2008 to be classified as "irritating to skin and eyes".
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:
- 1985-11-23 to 1985-12-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Guideline study; in deviation from OECD TG 404 occlusive dressing was used.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- occlusive dressing
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- - Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.7 kg - Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL test item
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- - Post exposure observation period: 8 days
- Observations at 1, 24, 48, 72 hours, 6, 9, 12 and 14 days after administration of the test substance - Number of animals:
- 3 males, 3 females
- Details on study design:
- - Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1; 24; 48; 72 h
- Score:
- 1.67
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.39
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.33
- Edema: 0.39
- Irritation index: 1.67/8 - Other effects:
- no further information
- Conclusions:
- According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
- Executive summary:
To test the acute skin irritant effect of the test item
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.
To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales.
According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
Reference
To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales. For details see attached table.
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:
- 1985-11-21 to 1985-11-23
- 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:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- - Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0 - 2.5 kg - Environmental conditions:
room temperature: 20°C (+/- 1°C)
humidity: 60% (+/- 5%)
Air change: 15 times/hour
Light: 12 hour light/dark rhythm
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany)
water: tap water ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animals, left eyes remained untreated
- Amount / concentration applied:
- 0.1 mL undiluted test item
- Duration of treatment / exposure:
- 72 hours after application, the treated eyes were rinsed with warm physiological saline
- Observation period (in vivo):
- - Postexposure observation period: 6 days
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment - Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- - Tool used to assess score: Na fluorescein / ophthalmic lamp / visual inspections
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1; 24; 48; 72 h
- Score:
- 1.42
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.06
- Conjuntivae (Chemosis): 0
- Overall irritation score: 1.42/110 - Other effects:
- no further information
- Conclusions:
- According to results of the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
- Executive summary:
To test the acute irritant effect on eyes and mucosa of the test item
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits.
A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.
According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
Reference
A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
Based on the assessment of two animal studies (skin and eye irritation) and according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
is not irritating to skin and eyes.
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