Registration Dossier
Registration Dossier
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EC number: 947-361-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-29 to 2002-03-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 30, 1996
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality, this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
Test material
- Reference substance name:
- Fatty acids, C12-20, reaction products with triethanolamine, di-Me sulfate-quaternized
- EC Number:
- 293-018-5
- EC Name:
- Fatty acids, C12-20, reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Praepagen T gehaertet
- Physical state: white wax
- Lot/batch No.: GC 01/198
- Expiration date of the lot/batch: Dec-2002
- Stability and homogeneity in the vehicle: is guaranted for 4 h in deinonized water by the sponsor:
- Storage condition of test material: at approx. 20 °C in a fume cupbord
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Mol:DH (Moellegaard)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: M & B A/S, P.O. bos 1079, 8680 Ry, Denmark
- Age at study initiation: no data
- Weight at study initiation: mean: 366 g
- Housing: individually in transparent macrolon cages (type V) on soft wood granulate in an air-conditioned room, 5 animals per cage
- Diet: ad libitum, ssniff Ms-H (V 2233)
- Water: ad libitum, tap water in plastic bottles
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 100 % in deionized water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge: 100 % in deionized water
- No. of animals per dose:
- 3 - preliminary study
10 – main study control
20 – main study treatment - Details on study design:
- PRELIMINARY STUDY AND DOSE RANGE FINDING
Left flank: 20 % (in deinonized water), 100% (moistened)
Right flank: 4, 20% (in deinonized water)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions
INDUCTION
100% (non-irritating)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions, three times at intervals of one week. Skin grading 24 and 48h following patch removal
CHALLENGE
100% (non-irritating); 14 days after the last induction exposure, application of the challenge patch on the shaved skin for 6h; skin evaluations 24 and 48h after patch removal
GRADING SYSTEM
Dermal reactions graded for erythema and edema by blind reading according to grading scale:
- No visible change: 0
- Discrete or patchy erythema: 1
- Moderated and confluent erythema: 2
- Intense erythema and swelling: 3 - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamic aldehyde
Results and discussion
- Positive control results:
- The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test. No unforeseen circumstances were observed which might have affected the quality or integrity of the study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
PRELIMINARY STUDY AND DOSE RANGE FINDING
No irritation at any dose. Concentration for induction and challenge: 100%
MAIN STUDY
No skin reaction observed in the control and test animals treated at the test item at 100% in de‐ionized water.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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