Registration Dossier
Registration Dossier
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EC number: 287-476-5 | CAS number: 85535-84-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the final RAR (EU, 2000), this was a well-conducted study, performed according to modern protocols and using suitable induction regimes; only basic data given in expert review
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Magnusson and Kligman method using guinea pigs: intradermal injection of Freund's complete adjuvant; dermal induction with test substance (a C10-13 chlorinated paraffin; assumed to be about 50% chlorination); dermal challenge with test substance; assessment of reactions and sensitisation potential of test substance.
- GLP compliance:
- not specified
- Type of study:
- other: Magnusson and Kligman test
Test material
- Reference substance name:
- Alkanes, C10-13, chloro
- EC Number:
- 287-476-5
- EC Name:
- Alkanes, C10-13, chloro
- Cas Number:
- 85535-84-8
- IUPAC Name:
- Alkanes, C10-C13, Chloro
- Details on test material:
- - Name of test material (as cited in secondary source): a C10-13 paraffin (assumed to be approximately 50% chlorinated)
- Substance type: technical product
- Physical state: probably liquid
- Analytical purity: no data
- Impurities (identity and concentrations): 1% stabiliser (Edenol B 74)
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (approximately 50% chlorinated)
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data in citing secondary source.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: Epicutaneous; type of covering (or lack thereof) not specified.
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- No data
Challengeopen allclose all
- Route:
- other: Epicutaneous; type of covering (or lack thereof) not specified.
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- No data
- No. of animals per dose:
- 20 treated animals. Number of controls not specified.
- Details on study design:
- Sensitization potential in guinea pigs was evaluated using the Magnusson and Kligman method (which involves injection of Freund's complete adjuvant, followed by dermal induction and then dermal challenge with the test substance). No data on induction exposure was given; animals were challenged with undiluted material, and then rechallenged one week later.
- Challenge controls:
- Yes, apparently at 24 h and 1 wk. No further data given
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- 2 animals showed marked diffuse redness; one showed slight redness and dryness at 24 h
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Undiluted. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: 2 animals showed marked diffuse redness; one showed slight redness and dryness at 24 h.
- Reading:
- rechallenge
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- Undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not relevant
- No. with + reactions:
- 0
- Clinical observations:
- None; number of controls not specified.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not relevant. No with. + reactions: 0.0. Clinical observations: None; number of controls not specified..
- Reading:
- rechallenge
- Hours after challenge:
- 168
- Group:
- negative control
- Dose level:
- Not relevant
- No. with + reactions:
- 0
- Clinical observations:
- None; number of controls not specified.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 168.0. Group: negative control. Dose level: Not relevant. No with. + reactions: 0.0. Clinical observations: None; number of controls not specified..
Any other information on results incl. tables
Number of controls not specified.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A C10-13 chlorinated paraffin (assumed to be approximately 50% chlorinated) was not sensitising to the skin of 20 guinea pigs when tested using the method of Magnusson and Kligman (involving dermal induction of test animals after administration of Freund's complete adjuvant, followed by dermal challenge and, one week later, rechallenge with the test substance).
- Executive summary:
The potential of a C10-13 chlorinated paraffin (assumed to be approximately 50% chlorinated) to produce skin sensitisation in guinea pigs has been assessed using the Magnusson and Kligman method (which involves injection of Freund's complete adjuvant, followed by dermal induction and then dermal challenge with the test substance). In the study (reported in the final RAR (EU, 2000) as well-conducted and performed according to modern protocols and using suitable induction times) animals were challenged with undiluted C10 -13 paraffin (50% chlorinated) and evaluated after 24 hours; 2/20 showed marked diffuse redness and 1/20 showed slight redness and dryness. When the same animals were re-challenged 1 week later, no skin reactions were seen. No skin reactions were seen in the control group.
In conclusion, the paraffin tested did not induce skin sensitisation in guinea pigs, and no classification or labelling with respect to skin sensitisation would be required under EU CLP or DSD regulations.
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