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Diss Factsheets
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EC number: 294-589-3 | CAS number: 91744-27-3
- 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
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In an intracutaneous test in albino guinea pigs, the control or test compound, dissolved in physiological saline, was injected every other day, three times each week until a total of 10 doses has been given. The injection sites were read and scored for diameter and intensity of erythema and height of edema at 24 and 48 hours following each injection. Two weeks after the administration of the tenth sensitization dose, a challenge dose was given by injection. Reactions were read and scored at 24 and 48 hours.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- No LLNA study performed with the substance is available for assessment. The test has been performed before the LLNA assay became the standard.
Test material
- Reference substance name:
- Castor oil
- EC Number:
- 232-293-8
- EC Name:
- Castor oil
- Cas Number:
- 8001-79-4
- IUPAC Name:
- Castor Oil
Constituent 1
- Specific details on test material used for the study:
- - Name as cited in study report: Wyandotte Surfactant (Ethylene oxide adduct)
- Lot: 0-21848-C
- Purity: considered to be free of impurities
- Appearance: yellow viscous liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 383 to 548 grams
- Housing: The animals were group housed according to the respective test group in metal cages suspended above the droppings in an air-conditioned room.
- Diet: The diet consisted of Purina Laboratory Chow supplemented with fresh cabbage three times weekly, ad libitum
- Water: ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- 0.9 %
- Concentration / amount:
- 0.1 % / First application: 0.05 mL, remaining nine doses: 0.1 mL
- Day(s)/duration:
- every other day (3 times a week) / 10 applications
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- 0.9 %
- Concentration / amount:
- 0.1 % / 0.05 mL
- Day(s)/duration:
- 14 days after last induction
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 8 animals in the treatment group, 4 animals in the positive control group.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:10
- Exposure period: every other day, three times each week, until a total of ten such sensitizing doses had been given.
- Site: A prepared area on the back and flanks of the respective guinea pigs. The backs were prepared by shaving with electric clippers and throughout the study were further shaved as necessary. In no case was the same injection site used more then once (each site was identified with a marking pen, directly below the site of injection). The test and control compounds were injected on the right flank of each animal and an identical volume of the vehicle was injected on the left side of each animal.
- Concentrations: 0.1 %
- Evaluation: The injection sites were read and scored for diameter and intensity of erythema and height of edema at 24 and 48 hours following each injection.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks following the administration of the tenth sensitizing dose
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 and 48 hours
EVALUATION CRITERIA
In the event that the score for a challenge dose was greater then the average score of the ten sensitizing doses, the control or test compound was considered to have produced dermal sensitization in the guinea pig. - Challenge controls:
- - Physiological saline was the control vehicle and was administered to the left flank of all the animals in this study.
- Positive control substance(s):
- yes
- Remarks:
- 0.1 % dinitro-1-Chlorobenzene in 0.9 % physiological saline
Results and discussion
- Positive control results:
- Two sensitizing injections were made before skin reactions became apparent to 2,4-dinitro-l-chlorobenzene. From the third sensitizing dose on, a reaction was observed in all of the guinea pigs after each injection. Scarring and alopecia were observed at several of the injection sites. Reactions to the challenge dose were severe in all of the guinea pigs. Within 48 hours the center of the wheal appeared necrotic and was followed by formation of a scab and scar. The mean score for each of the four animals responding to the challenge dose of 2,4-dinitro- 1-chlorobenzene was 100 % greater than the mean values obtained from the sensitizing doses. Based upon the results obtained all of the guinea pigs in this positive control group were considered to have been dermally sensitized to 2,4-dinitro-1-chlorobenzene.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- wheal and flare score of a greater magnitude then those observed during the sensitizing doses
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 4
Any other information on results incl. tables
- All of the guinea pigs used in this study appeared essentially normal at all times.
- Mild to moderate reactions to the sensitizing doses of the test compound were observed. This could be considered as a reflection of drug irritancy. It will also be noted that on several occasions similiar but somewhat less pronounced reactions were observed following the injection of the control vehicle in the same animal.
- Four-of-eight guinea pigs responded to the challenge dose. Two of those responding produced a wheal and flare score of a greater magnitude then those observed during the sensitizing doses. These observed reactions however were not of the magnitude of any of those observed in the positive control group represented by 2,4-dinitro-1-chlorobenzene.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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