Registration Dossier
Registration Dossier
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EC number: 442-080-3 | CAS number: -
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: Test conducted according to internationally accepted testing procedures and according to the GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia, shipping slip 9EC004774.
- Age at study initiation: 6 weeks old.
- Weight at study initiation: between 352 and 398 g.
- Housing: 2/3 animals/cage in air conditioned room.
- Diet: standard GLP coded 8 GP 22 produced by Charles River and supplemented with vitamins and trace elements.
- Water: filtered municipal water.
- Acclimation period: 5 days. Animals were observed daily to ascertain their fitness for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 55 ± 15 %
- Air changes: about 15-20 per hrs, filtered on HEPA 99.97 %.
- Photoperiod: artificial light; 12 hrs dark/12 hrs light.
- cage: wire cages (40.5 x 38.5 x x18) with a stainless steel feeder. The waste that dropped through the wire bottom onto removable paper was periodically disposed.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- Formulates in cottonseed oil and in FCA (Freund's Complete Adjuvant) were both prepared at 1 % concentration. For the injection in FCA the test article was mixed with FCA at 2 % concentration and then an equal volume of deionised water was added to obtain 1 % concentration.
Formulates at 25 % and 10 % concentration in cottonseed oil were prepared for booster and challenge, respectively.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Formulates in cottonseed oil and in FCA (Freund's Complete Adjuvant) were both prepared at 1 % concentration. For the injection in FCA the test article was mixed with FCA at 2 % concentration and then an equal volume of deionised water was added to obtain 1 % concentration.
Formulates at 25 % and 10 % concentration in cottonseed oil were prepared for booster and challenge, respectively.
- No. of animals per dose:
- Number of animals in the preliminary test: 2
Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
0.1 ml of 3 test item concentrations (0.5, 1, 5 %, vehicle cottonseed oil) was injected into 3 different areas of the shoulder region of two animal, being 5 %
the highest concentration technically administrable.
The animals were observed for 48 hours.
No effect at 0.5 %, Irritation at 1 %, eschar at 5 %
Following topical administration, no effect was recorded at 10 %, moderate irritation after application of 25 % test item and severe irritation with the dose at 50 %.
MAIN STUDY: Intradermal at day 0 + Topical at day 7
A. INDUCTION EXPOSURE 1 - Intradermal
- Concentration: 1 %
- Test groups: three injections at day 0: 0.1 ml FCA emulsion (1:1 water) + 0.1 ml test item + 0.1 ml test item with FCA
- Control group: three injections 0.1 ml FCA emulsion (1:1 water) + 0.1 ml vehicle + 0.1 ml vehicle with FCA
B. INDUCTION EXPOSURE 2 - Topical
- Concentration: 25 %
- Booster at day 7: a filter paper was fully loaded with the test item and applied to the skin areas clipped the day before. The patch was covered by an overlapping waterproof plastic adhesive tape. The dressing was left in place for 48 hours.
C. CHALLENGE EXPOSURE
- Concentration 10 % (Occlusive patch)
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: occlusive parch 2 x 2cm loaded with the test item or the vehicle - Positive control substance(s):
- yes
- Remarks:
- 2 -mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
No reaction was observed on the challenged animals.
No deaths occurred and no signs of general toxicity were observed in any animal.
Body weight was within the range for the whole study period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Not sensitising.
- Executive summary:
The sensitising potential of the test article was assessed in guinea pigs according to the OECD guideline 406.
No animals treated with the test article showed a positive reaction at the challenge.
Conclusion
According to the CLP Regulation, a substance is classified as skin sensitizer when in the Guinea pig maximisation test the response of at least 30 % of the animals is considered as positive.
In the current experiment none of the animals tested showed any skin reaction.
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