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EC number: - | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted prior to the availabilty of the LLNA skin sensitisation test.
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white, Crl:HA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: Not stated
- Weight at study initiation: Main test: 356–426 g (males); 344–383 g (females)
- Housing: 5/cage
- Diet: pelleted diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): ca. 16
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10%
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test group: 5 males and 5 females
control group: 3 males and 2 females - Details on study design:
- RANGE FINDING TESTS:
Intra-dermal injection of 5, 2.5 and 1% of the test substance caused skin reactions. At a concentration of 0.5% test substance no skin reactions were observed.
Dermal applications of 50, 25 and 5% of the test substance showed skin reactions. No skin reactions were observed after the dermal application of the test article at a concentration of 1%.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal
- Test groups:
1) FCA 50% (v/v) diluted in aqua ad iniectabilia,
2) test substance 0.5% in aqua ad iniectabilia,
3) test substance 0.5% in aqua ad iniectabilia/FCA
- Control group:
1) FCA 50% (v/v) diluted in aqua ad iniectabilia,
2) aqua ad iniectabilia,
3) aqua ad iniectabilia 50% (v/v) diluted in FCA
Epicutaneous
- Exposure period: 48 h
- Test groups: 10% test substance in petrolatum
- Control group: vehicle
- pretreatment with 10% SDS to induce irritation
B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test groups: 1% test substance in petrolatum
- Control group: 1% test substance in petrolatum
- Evaluation (hr after challenge): 24, 48 - Positive control substance(s):
- yes
- Remarks:
- Benzocaine
Results and discussion
- Positive control results:
- Sensitisation rate (50% test substance) at 24 h: 60%
Sensitisation rate (50% test substance) at 48 h: 70%
Sensitisation rate (25% test substance) at 24 h: 30%
Sensitisation rate (25% test substance) at 48 h: 30%
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% interdermal induction, 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% interdermal induction, 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% interdermal induction, 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% interdermal induction, 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive controls are assessed on regular basis in the laboratory
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The registration substance was not a skin sensitizer in this GPMT test. Thus, the test substance is not classified for skin sensitisation according to the criteria laid down in Regulation (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.
- Executive summary:
The skin sensitizing potential of the lyophilised registration substance (100% a.i.) was tested in 10 Pirbright white Guinea pigs using the Guinea pig maximisation test, according to EC method B.6 (1996) and OECD guideline 406 (1992). The intradermal induction concentration was 0.5%, the epicutanous induction was 10% and the challenge concentration tested was 1% of the test item.
No deviations from the methods described by the guideline were reported.
No allergic skin reactions occurred in test animals 24 and 48 h after the end of the challenge procedure with the test item at a challenge concentration of 1% in petrolatum. The sensitisation rate was 0%.
Thus, Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid was not a skin sensitizer in this GPMT test and is is not classified for skin sensitisation according to the criteria laid down in Regulation (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.
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