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EC number: 919-006-8 | CAS number: -
- 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
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Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 406: GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 406: GLP.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Acceptable Buehler test that followed sound scientific principles.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
- No. of animals per dose:
- 10 animals
- Details on study design:
- 0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. The same skin site was used for the first two applications but due to the severe irritation that had occurred in the test and positive control groups a different site was used for the third sensitizing application. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. The application sites for sensitizing and challenge doses were scored for erythema and edema 24 and 48 hours after patch removal. To assist in the scoring of the response to the final challenge dose the test site was depilated 3 hours prior to examination by using a commercially available depilatory cream. Positive control (2,4-dinitrochlorobenzene), vehicle control and naive control groups were included in this study. Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
- Positive control substance(s):
- yes
- Remarks:
- Sensitizing doses:2,4-dinitrochlorobenzene: Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
The skin reactions after challenge applications were:
Test group - No dermal irritation in any animal;
Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;
Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;
Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;
Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- other: HPV Summary
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Acceptable Buehler test that followed sound scientific principles.
Test material
- Details on test material:
- Straight run kerosene
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.4 ml of a 1% solution in paraffin oil
- No. of animals per dose:
- 10 animals
- Details on study design:
- 0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. The same skin site was used for the first two applications but due to the severe irritation that had occurred in the test and positive control groups a different site was used for the third sensitizing application. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. The application sites for sensitizing and challenge doses were scored for erythema and edema 24 and 48 hours after patch removal. To assist in the scoring of the response to the final challenge dose the test site was depilated 3 hours prior to examination by using a commercially available depilatory cream. Positive control (2,4-dinitrochlorobenzene), vehicle control and naive control groups were included in this study. Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
- Positive control substance(s):
- yes
- Remarks:
- Sensitizing doses:2,4-dinitrochlorobenzene: Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 ml of 0.1% w/v suspension in acetone.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
Any other information on results incl. tables
The skin reactions after challenge applications were:
Test group - No dermal irritation in any animal;
Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;
Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;
Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;
Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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