Registration Dossier
Registration Dossier
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EC number: 947-917-0 | 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:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- Amines, N-C12–C14(even numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Molecular formula:
- n.a. (UVCB substance)
- IUPAC Name:
- Amines, N-C12–C14(even numbered)-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 (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: not stated
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)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other:
- Remarks:
- intradermal: aqua ad iniectabilia; epicutaneous: petrolatum
- Concentration / amount:
- Intradermal: 0.5% test substance
Epicutaneous: 10% test substance - Day(s)/duration:
- Exposure period (epicutaneous): 48 h
- Adequacy of induction:
- other: skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% test substance in petrolatum
- Day(s)/duration:
- day 21; 24 h exposure
- 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
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- DOPA-Glycinate was not a skin sensitizer in this GPMT test.
- Executive summary:
The skin sensitizing potential of DOPA-Glycinate (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 challenge concentration tested was 1% of the test item in petrolatum.
No deviations from the methods prescribed 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 concentration of 1% in petrolatum. The sensitisation rate was 0%.
Thus, DOPA-Glycinate was not a skin sensitizer in this GPMT test.
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