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EC number: 272-683-5 | CAS number: 68908-82-7
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The procedure employed is as followed:
Induction Phase:
Guinea pigs of both sexes, divided in groups of 8 animals each, are shaved on the upper dorsal area. About one hour later, 0.1 ml of the test material is applied to 8 cm2 of the test area. After this pre-treatment, the animals are exposed to the UV B-irradiation for 15' and thereafter to UV A-irradiation for four hours (Westing-house black light tubes) from a distance of 25 cm. The application of the test material and the following irradiation are performed every second day, total nine times in 18 days. Skin reading for evidence of erythema is made 24 hours after each application.
Challenge Phase:
After a rest period of ten days, the guinea pigs are shaved on both flanks and the test area marked. 0.025 ml of the test material is applied to 2 cm2 of both skin sites, for challenging. Then, the left flank only is irradiated in the same way as described for induction. Skin reading for evidence of erythema is made 24 hours and 48 hours after challenging. The reactions on the left and right flank are compared for estimation of the photosensitizing capacity. Moreover, a control group of six animals is tested and read just as the experimental group during the challenge phase. - GLP compliance:
- no
- Remarks:
- study pre-dates introduction of GLP
- Type of study:
- other: Guinea Pig Assay of Photosensitizing potential
- Justification for non-LLNA method:
- LLNA not available at time of testing
Test material
- Reference substance name:
- η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol
- EC Number:
- 267-434-2
- EC Name:
- η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol
- Cas Number:
- 67860-00-8
- Molecular formula:
- C26H32N2O
- IUPAC Name:
- 8,8-di(1H-indol-3-yl)-2,6-dimethyloctan-2-ol
- Reference substance name:
- Indole
- EC Number:
- 204-420-7
- EC Name:
- Indole
- Cas Number:
- 120-72-9
- Molecular formula:
- C8H7N
- IUPAC Name:
- 1H-indole
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Reference substance name:
- 1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol
- Cas Number:
- 1642782-49-7
- Molecular formula:
- C18H27NO2
- IUPAC Name:
- 1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol
- Reference substance name:
- Unknown constituents
- IUPAC Name:
- Unknown constituents
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- Test Material: Indolene Liquid, 50% Indolene in Castor Oil
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The guinea pig is the animal of choice for studying the sensitizing capacity of single chemical compounds, pharmaceutical and cosmetic products. The guinea pig has proved to be useful for identifying potential photosensitizers.
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 8 animals per group
- Details on study design:
- Induction Phase:
Guinea pigs of both sexes, divided in groups of 8 animals each, are shaved on the upper dorsal area. About one hour later, 0.1 ml of the test material is applied to 8 cm2 of the test area. After this pre-treatment, the animals are exposed to the UV B-irradiation for 15' and thereafter to UV A-irradiation for four hours (Westing-house black light tubes) from a distance of 25 cm. The application of the test material and the following irradiation are performed every second day, total nine times in 18 days. Skin reading for evidence of erythema is made 24 hours after each application, according to the following scale:
0 = no erythema
1 = slight erythema
2 = moderate erythema
3 = strong erythema
Challenge Phase:
After a rest period of ten days, the guinea pigs are shaved on both flanks and the test area marked. 0.025 ml of the test material is applied to 2 cm2 of both skin sites, for challenging. Then, the left flank only is irradiated in the same way as described for induction. Skin reading for evidence of erythema is made 24 hours and 48 hours after challenging. The reactions on the left and right flank are compared for estimation of the photosensitizing capacity. Moreover, a control group of six animals is tested and read just as the experimental group during the challenge phase. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% Indolene
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% Indolene
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions used the 10% solution of Indolene Liquide (i.e., 5% Indolene) showed no photosensitizing potential.
- Executive summary:
In a guinea pig photosensitizing assay, 8 guinea pigs were exposed to 5% Indolene nine times over 18 days. After a ten-day rest period, the animals were challenged with 5% Indolene and scored for erythema at 24 and 48 hours. No erythema was observed and Indolene was judged to be non-sensitizing at 5% under the test conditions.
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