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Toxicological information

Skin sensitisation

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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:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: DOPA-Glycinate

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 group
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 group
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.