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EC number: 293-766-2 | CAS number: 91082-52-9
- 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)
- Remarks:
- This in vivo Guinea pig maximisation test was conducted before the amendments to the data requirements in Annex VII and VIII came into force.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Maximisation test according to Magnusson and Kligman (1970)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted in 1988, before the LLNA method was established as the standard in vivo study for skin sensitisation
Test material
- Reference substance name:
- Tar bases, coal, lutidine fraction
- EC Number:
- 293-766-2
- EC Name:
- Tar bases, coal, lutidine fraction
- Cas Number:
- 91082-52-9
- IUPAC Name:
- Tar bases, coal, lutidine fraction
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 208-320 g
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
- Indication of any skin lesions: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.05 to 0.1 mL of a 3% w/v solution
- Day(s)/duration:
- Start of study
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.2 to 0.3 mL of a 30% w/v solution
- Day(s)/duration:
- One week after intradermal injection for 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.05 to 0.1 mL of a 10% and a 30% (w/v) solution
- Day(s)/duration:
- Two weeks after second induction for 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 19 animals
- Details on study design:
- All animals were challenged two weeks after the topical induction by application of 0.05 to 0.1 mL of a 30% (w/v) solution of the test substance in corn oil to the left shorn flank and 0.05 to 0.1 mL of a 10% (w/v) solution of the test substance in corn oil to the right shorn flank for 24 hours, under occlusive dressings. The challenge sites were examined 24 and 48 hours after removal of the dressings and any erythema present were scored.
- Challenge controls:
- 10 animals were treated in the same way as the 19 animals used in the study
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- None reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% w/v
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- None reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- None reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- None reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
Any other information on results incl. tables
Following challenge with a 30% (w/v) solution of the test substance in corn oil, scattered mild redness was seen in three out of nineteen test animals. No response was seen in any of the control animals. The net percentage response was 16%. Therefore, challenge with the 30% (w/v) solution elicited a mild skin sensitisation response in previously induced guinea pigs.
Following challenge with a 10% (w/v) solution of the test substance in corn oil, scattered mild redness was seen in one of the nineteen test animals. No response was seen in any of the control animals. The net percentage response was 5%. Therefore, challenge with the 10% (w/v) solution elicited a weak skin sensitisation response in previously induced guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not elicit responses in this guinea pig maximisation test that would trigger a classification for skin sensitisation.
- Executive summary:
The skin sensitisation potential of the test substance was investigated under non-GLP in a guinea pig maximisation test following the principles as described by Magnusson and Kligman (1970). The principles of the study are equivalent or similar to those laid down in the relevant OECD regulatory guideline. The experiment is considered relevant, adequate and conclusive.
The study involved two main procedures: an induction of a response and a challenge of that response. The induction was carried out upon 19 female guinea pigs, bodyweight range from 208-320 g. Firstly, intradermal injections of 0.05 to 0.1 mL of the following were made to the shorn scapular regions:
- Freund's Complete Adjuvant plus corn oil in the ratio 1:1,
- a 3% (w/v) solution of the test substance in corn oil,
- a 3% (w/v) solution of the test substance in a 1:1 mixture of Freund's Complete Adjuvant and corn oil.
Secondly, one week later a topical application of 0.2 to 0.3 mL of a 30% (w/v) solution in corn oil of the test substance was made to the shorn scapular region and was held in contact with the skin for 48 hours by means of occlusive dressings.
The nineteen test animals plus ten negative control animals were challenged two weeks after the topical induction by application of 0.05 to 0.1 mL of a 30% (w/v) solution of the test substance in corn oil to the left shorn flank and 0.05 to 0.1 mL of a 10% (w/v) solution of the test substance in corn oil to the right shorn flank for 24 hours, under occlusive dressings. The challenge sites were examined 24 and 48 hours after removal of the dressings and any erythema present were scored.
Following challenge with the 30% solution, scattered mild redness was seen in three out of 19 test animals. No responses were seen in any of the control animals. The net percentage response was 16%. Following challenge with a 10% solution, scattered mild redness was seen in one of the nineteen test animals. No response was seen in any of the control animals. The net percentage response was 5%.
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