Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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: Guideline study, GLP
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.
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

Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
Intradermal: 0.5% test substance
Epicutaneous: 10% test substance
Challenge: 1% test substance in petrolatum
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Intradermal: 0.5% test substance
Epicutaneous: 10% test substance
Challenge: 1% test substance in petrolatum
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
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
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: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
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: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 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.

There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account. For skin sensitisation, there is no reason to believe that results obtained in guinea pigs would not be applicable to humans.


Migrated from Short description of key information:
Guinea pig maximisation test: not sensitising (OECD guideline 406; GLP); Induction: intradermal (0.5%) + epicutaneous (10% in petrolatum); Challenge: topical (1% in pretrolatum)

Justification for selection of skin sensitisation endpoint:
OECD & EC guideline study, GLP

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on relevant, reliable and adequate data, DOPA-Glycinate does not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 and Directive 67/548/EEC with respect to skin sensitisation.