Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 619-567-6 | CAS number: 848301-66-6
- 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:
- 2 (reliable with restrictions)
- 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: 481-670-5; 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 06-31-0126-00 from 1st Nov, 2006].
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Huntington Life Sciences
- Type of study:
- Freund's complete adjuvant test
Test material
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Kerosine (Fischer - Tropsch), limited range, C8-12 - branched and linear
- IUPAC Name:
- Kerosine (Fischer - Tropsch), limited range, C8-12 - branched and linear
- Details on test material:
- - Name of test material (as cited in study report): Shell MDS (M) Kerosine
- Lot/batch No.: 20001 1380
- Substance type: test substance 'Shell MDS(M) Kerosine' is a near analogue to 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear'; this substance is a limited range (C8-C12; boiling range ~160-200°C) Kerosine (Fischer-Tropsch), branched and linear alkane, which consists of approximately 50-60% linear and 40-50% branched material until ca. C12 when branching starts to increase. The branching consists almost exclusively of single methyl groups. There are mostly all mono branches below--> the test substance 'Shell MDS (M) Kerosine' is comparable to 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear'.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentrations of test material and vehicle used at each stage of induction:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied
Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v 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:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied
Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v in paraffin oil
- No. of animals per dose:
- TEST GROUP: 20 (10m/10f)
CONTROL GROUP: 20 (10m/10f)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (v/v)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- eschar formation and oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (v/v)
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (v/v)
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- eschar formation and oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (v/v)
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (v/v)
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- paraffin only
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: paraffin only. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (v/v)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- eschar formation and oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (v/v)
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- eschar formation and odema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: eschar formation and odema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 % (v/v)
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% (v/v)
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- paraffin only
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- exfoliation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Any other information on results incl. tables
Signs of irritation during induction: 50% v/v - moderate erythema and oedema; no dermal response was evident following a similar administration of 50% v/v of test material in paraffin oil.
Occluded topical induction of test material as supplied gave rise to slight erythema, eschar formation, exfoliation, yellow staining, loss of flexibility and oedema.
Evidence of sensitization at each challenge: Challenge application of 50% v/v test material in paraffin oil gave rise to eschar formation or oedema in six test and five control animals. Exfoliation was evident in seventeen test and nineteen control animals. Challenge application of 10% v/v test material in paraffin oil caused eschar formation in two test and no control animals; a further seven test and two control animals showed slight erythema. Exfoliation was evident in twelve test and sixteen control animals. Challenge application of paraffin oil alone gave rise to slight erythema in two control animals. Exfoliation was evident in thirteen test and fourteen control animals. On this basis it is considered that a significant dermal response was observed in no test animal following challenge with 50% v/v test material in paraffin oil and in two test animals following challenge application of 10% v/v test material in paraffin oil.
Other observations: Abrasions were evident in the majority of test animals after second (topical) induction; the control animals remained in overt good health. One test animal was found dead on Day 2; necropsy revealed incomplete collapse of the lungs. All surviving animals achieved anticipated overall bodyweight gains.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- It was concluded that, under the conditions of this study, repeated administration of 'Shell MDS (M) Kerosine', a analogue to
'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' 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.
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.