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EC number: 257-843-4 | CAS number: 52315-75-0
- 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
In a study with guinea pigs the test item was applied to the site of challenge at flank to induce delayed type skin reaction, but redness was not observed. In 0.1% DNCB sensitized guinea pigs used as a positive control, erythema were evaluated as “grade 2” in all animals. When a 50% test item solution and 0.1% DNCB were applied to the FCA sensitized guinea pigs, no redness was observed in the flank. Therefore, the test item was not judged to be a source antigen eliciting contact skin allergic reaction.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Modified maximization test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 1984
- Specific details on test material used for the study:
- not further specified
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female Hartley strain guinea pigs (weighing about 250 g on arrival, at age 3 - 4 weeks) were purchased from Shizuoka Agricultural Cooperative Association for Laboratory Animals and housed in wire cages with automatic water supply and automatic cleaning in an animal facility adjusted to temperature 21 - 25°C and humidity 45 - 70%. Animals were fed Oriental Yeast Co. RC-4 produced within recent 3 months, and allowed to drink tap water at libitum.
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1.25 % (w/w)
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 50 % (w/w)
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 50 % (w/w)
- No. of animals per dose:
- 10-15
- Details on study design:
- Types of sensitized groups
The test item was used to sensitize 15 animals, DNCB to sensitize 10 animals, and FCA to sensitize 10 animals that served as the control (body weight at the time of sensitization was 274 - 450 g). Each cage was labelled with study number, the type of sensitizing antigen and the number of animals/cage, while guinea pigs were individually identified by use of picric acid and oily ink.
Methods of sensitization
1.) Sensitization by intradermal injection
Each antigen for immunization emulsified with FCA was intradermally injected to 4 corners of the shaved scapular region (3×4 cm) of the guinea pig skin (0.1 mL/site), to sensitize the guinea pig.
2.) Sensitization by spreading
Immediately after intradermal injection, the stratum corneum at the site of injection was nicked with a 23 G needle to create a #-shaped injury, then a piece of vinyl filter paper (3×4 cm) spread with 0.4 mL each of antigen for immunization was applied to the shaved region, fixed with an adhesive tape (Johnson & Johnson), and left there for 24 hours under occlusion to sensitize the animal. After removal of vinyl filter paper, occlusive dressing for 24 hours was repeated twice. On day 8 after the first sensitization, the guinea pig scapular region was again shaved, and spread with about 200 mg/animal of 10% SDS petrolatum. At 24 hours after spreading, a piece of vinyl filter paper spread with 0.2 mL each of antigen for immunization (3×4 cm) was applied to the same site, fixed with an adhesive tape, and left there under occlusion for 48 hours. 50% Nε-lauroyl-L-lysine was used in Nε-lauroyl-L-lysine sensitized group, 0.1% DNCB solution in DNCB sensitized group, and olive oil in FCA sensitized group, in spreading.
3.) Induction of delayed type skin reaction
On day 22 after the first sensitization, a piece of vinyl filter paper (2×3 cm) spread with 2 mL of antigen for challenge (50% Nε-lauroyl-L-lysine or 0.1% DNCB solution) was applied to the shaved and actively sensitized flank of the guinea pig, fixed with adhesive tape, and left there for 24 hours under occlusion to induce delayed type skin reaction. Time for the removal of tape was at 24 hours after challenge, and the flank was observed at 24 hours and 48 hours after challenge, twice in total. The findings in this observation were classified to the following 4 gradings:
0 = No macroscopic change
1 = Slight or minimal erythema
2 = Moderate erythema
3 = Severe erythema and oedema
As control for Nε-lauroyl-L-lysine sensitized and DNCB sensitized groups, the same amount of antigen for challenge as used in the challenge was applied, namely, 50% Nε-lauroyl-L-lysine and 0.1% DNCB were applied respectively to the left and right flank of the FCA sensitized guinea pig, and the flank was observed for the presence or absence of the symptoms elicited by primary stimulation with the samples such as redness and oedema. - Challenge controls:
- see above
- Positive control substance(s):
- yes
- Remarks:
- DNCB
- Positive control results:
- DNCB caused an erythema "grade 2" in all animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Test item was not allergic to the skin.
- Executive summary:
In a study with guinea pigs the test item was applied to the site of challenge at flank to induce delayed type skin reaction, but redness was not observed. In 0.1% DNCB sensitized guinea pigs used as a positive control, erythema were evaluated as “grade 2” in all animals. When a 50% test item solution and 0.1% DNCB were applied to the FCA sensitized guinea pigs, no redness was observed in the flank.
Therefore, the test item was not judged to be a source antigen eliciting contact skin allergic reaction.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a study with guinea pigs the test item gave no indication for a significant skin sensitizing potential. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.
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