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EC number: 619-566-0 | CAS number: 848301-65-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This endpoint has been reviewed, assessed and accepted by UK-HSE as competent authority for the notification of a new substance [EC number: 481-730-0; Data from UK-Notification Dossier by Shell U.K. Limited in accordance with Directive 92/32/EEC (Articles 7/8/9/12) O.J.L 154, Volume 35, 5 June 1992; Notification Report 06-31-0125-00 from 1st Nov, 2006].
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Principles of method if other than guideline:
- only 10 animals were used in the treatment group (instead of a minimum of 20 animals)
- GLP compliance:
- yes
- Remarks:
- American Petroleum Institute
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): API-83-19, which is Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Substance type: test substance API-83-19 is a near analogue to Naphta (Fischer-Tropsch), light, C4-10 - branched and linear; it`s defined as:
'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers
predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
--> the test substance API 83-19 is comparable to 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' and therefore read across is
valid.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil
- No. of animals per dose:
- - test group: 10
- naive control group: 10
- vehicle control group: 10
- positive control group: 20
- naive positive control group: 20
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: 2,4-Dinitrochlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive control group
- Dose level:
- 25% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- paraffin only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- -
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0,1% w/v
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema and edema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0,1% w/v. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: very slight erythema and edema.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive positive control group
- Dose level:
- 0,1% w/v
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive positive control group. Dose level: 0,1% w/v. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
Any other information on results incl. tables
Observations
- Test group: A very slight erthyema reaction was exhibited by one animal. The reaction did not exceed the highest reaction of the naive control animals.The other nine animals exhibited no reaction.
- Naive control group: A very slight erthyema reaction was exhibited by one animal. The other nine animals exhibited no reaction.
- Negative control group: No reaction was exhibited by any animal.
- Positive control group: Very slight to severe irritation was exhibited by all 20 animals. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals.
- Naive positive control group: Three of the 20 animals exhibited very slight erythema reactions. The other 17 animals exhibited no reaction.
Other observations:
- All animals appeared normal throughout the study period with the exception of two test animals, five positive control animals, and two naive
control animals which exhibited soft stool/diarrhea sporadically throughout the study.
- A slight bodyweight loss of 5g was recorded during the last week of the study for one test animal. This animal exhibited normal bodyweight gains at all other weighings. Normal bodyweight gains were recorded for all other animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- - Skin reactions to the induction dose: Slight to moderate erythema and slight edema were observed in the animals dosed with test material.
- Skin reactions to the challenge dose: the test group did not show any skin reaction, like erythema and edema after challange, except 1 out of 10
animals.
Result: It was concluded that, under the conditions of this study, repeated administration of 'Naphtha (petroleum), light alkylate', a structural
analogue to 'Naphtha (Fischer-tropsch), light, C4-10 - branched and linear', also had a weak potential to cause delayed contact hypersensitivity in
guinea pigs. However, the incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer.
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