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EC number: 285-549-6 | CAS number: 85116-96-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted accorrding to OECD protocol and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable in-vivo GMT already performed.
Test material
- Reference substance name:
- Fatty acids, C10-20-neo-
- EC Number:
- 285-549-6
- EC Name:
- Fatty acids, C10-20-neo-
- Cas Number:
- 85116-96-7
- Molecular formula:
- C10H20O2 ... C20H40O2
- IUPAC Name:
- C10-20-neo-Fatty acids
- Details on test material:
- - Name of test material (as cited in study report): Versatic 1019
- Substance type: brown liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- 0.1 ml test material in 50:50 Freund's complete adjuvant and maize oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 0.1 ml test material in 50:50 Freund's complete adjuvant and maize oil
- No. of animals per dose:
- 4 per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL INJECTION
- No. of exposures: 1
- Exposure period: 6 days
- Test groups: single group
- Control group: Freund's complete adjuvant or maize oil
- Site: each side of the midline in the shorn skin of the shoulder region
B. INDUCTION EXPOSURE - TOPICAL APPLICATION
- No. of exposures: 1
- Exposure period:6 days after intradermal injection
- Test groups: single group
- Control group: Freund's complete adjuvant or maize oil
- Site: each side of the midline in the shorn skin of the shoulder region
- Concentrations: 0.5 ml via occluded patch.
C. CHALLENGE EXPOSURE
- No. of exposures: Single 24 hour exposure
- Day(s) of challenge: 2 weeks after topical application
- Test groups: yes
- Control group: yes
- Site: 2.5x2.5 cm area on flank
- Evaluation (hr after challenge): 24 and 48 hours after removal - Positive control substance(s):
- yes
- Remarks:
- MBT
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 18
- Total no. in group:
- 18
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 18.0. Total no. in groups: 18.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 18
- Total no. in group:
- 18
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 18.0. Total no. in groups: 18.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the VERSATIC 1019 is sensitizing.
- Executive summary:
In this study, VERSATIC 1019 was examined for skin sensitization potential in the guinea pig maximization procedure of Magnusson and Kligman.
Groups of twenty female guinea pigs were used for the test and a further ten females as controls.
Induction was accomplished in two stages.
1) Intradermal injection
Two rows of three injections were made, one on each side of the midline in the shorn skin of the shoulder region.
2) Topical application
One week after the intradermal injections, the same area was clipped free from hair. A 4x4 cm patch of filter paper was soaked in a solution of the test material and placed over the injection sites and covered with an occlusive dressing. The dressing was left in place for 48 hours.
The challenge procedure was carried out two weeks after topical induction. Challenge was accomplished by topical application of the test material to the flank of animals via an occluded patch. The challenge lasted 24 hours.
Immediately after the challenge, and then again at 24 and 48 hours later, each animals was examined for signs of skin sensitization.
All 18 surviving guinea pigs were positive for a sensitisation response.
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