Registration Dossier
Registration Dossier
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EC number: 610-150-4 | CAS number: 438193-30-7
Toxicological information
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:
- The study was conducted according to the EU method B.6 and in compliance with GLP. The substance used for read across (Triphenyl-(4-vinyl)cyclohexyl-methylphospohniumiodid, D 6) is structurally very similar to the registered substance Triphenyl-(4-propenyl)cyclohexyl-methylphosphoniumiodid (E 6). The only difference concerns the length of side chain in para position of the hexylring being a vinyl group for D 6 and a propenyl group for E 6. Therefore a read-across from D 6 to E 6 is considered reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1171067-76-1
- IUPAC Name:
- 1171067-76-1
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 days
- Weight at study initiation: 323.6 g +/- 15.2 g
- Housing: up to 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 0.5% Tylose in deionised water
- Concentration / amount:
- 1% solution for intrcutaneous induction.
25% solution for epicutaneous induction and challenge on day 21.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% Tylose in deionised water
- Concentration / amount:
- 1% solution for intrcutaneous induction.
25% solution for epicutaneous induction and challenge on day 21.
- No. of animals per dose:
- 10
- Details on study design:
- Main study:
First induction week (intradermal injection), 3 pairs of intradermal injections (0.1 mL):
Dose group:
Injection 1: mixture of Aqua pro injectione and FCA (1: 1, v/v)
Injection 2: 1 % (w/v) suspension ofthe test item in TS
Injection 3: 1 % (w/v) suspension of the test item in FCA/ Aqua pro injectione (1: 1, v/v)
Control group:
Injection 1: mixture of Aqua pro injectione and FCA (1: 1, v/v)
Injection 2: TS
Injection 3: 50% mixture (w/v) of TS in a mixture of Aqua pro injectione and FCA (1 :1, v/v)
Second induction week (epidermal application):
Dose group:
One layer of filter paper (2 x 4 cm) was loaded with 0.5 g of the 25 % (w/w) mixture of the test item with vaseline. One patch each was then placed on the skin ofboth sides ofthe body.
Control group:
One layer of filter paper (2 x 4 cm) was loaded with 0.5 g of vaseline. One patch each was then placed on the skin of both sides of the body.
In both groups the papers were covered with film and held in contact with the skin by occlusive dressing. After 48 hours the patches were
removed and the administration areas were cleaned with corn oil.
Challenge (epidermal application, week 3):
Dose and control group:
One strip of gauze patch was loaded with 0.5 g of the 25 % (w/w) mixture of the test item with vaseline and applied to the right flank of all animals.
Other strips of gauze patch were loaded with 0.5 g of vaseline and applied to the left flank of all animals.
All patches were covered with film and held in contact with the skin by occlusive dressing. After 24 hours the patches were removed and the
administration areas were cleaned with corn oil. - Positive control substance(s):
- yes
- Remarks:
- Benzocaine
Results and discussion
- Positive control results:
- The epicutaneous administration of the 10 % suspension of Benzocaine in Paraffinum liquidum caused a slight to moderate erythema (grade 1-2)
in all animals of the dose group both on day 23 and on day 24. The same administration to the control animals did not cause any irritation sign.
The administration of Paraffinum liquidum to the left flank did not cause any irritation sign in any of the animals. The skin-fold thickness was
statistically significantly increased in the treated animals on all days of measurement after challenge.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- slight erythema and oedema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: slight erythema and oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the classification system for skin reactions of the Appendix 6 to Directive 2001/59/EU E 6 (by ready-across from results for D 6) is not to classify as skin sensitiser accordingto the results of this sensitisation study.
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