Registration Dossier

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:
other: Study according to OECD guideline 406 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: >99%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at delivery: 4 - 6 weeks
- Age at pretest start/beginning of acclimatisation period: 4 - 6 weeks
- Body weight at pretest start: 310 - 363 g (pretest group)
- Body weight at beginning of acclimatisation period: 335 - 406 g (control and test group)
- Housing: Individually in Macrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum): Pelleted standard Nafag Ecosan 845 25W4, batch nos. 91/98 and 103/98, guinea pig breeding / maintenance diet ("Nafag", Nähr- und Futtermittel AG, CH-9202 Gossau), ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum, once weeckly additional supply of ascorbic acid (approx. 1 g/l) via the drinking water was provided
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatisation for the animals of the pretest. Only animals without any visible signs of illness were used for the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 38 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12, music was played during the light period


DISTRIBUTION OF ANIMALS (ALL FEMALE)
Control group: 5
Test group: 10
Intradermal pretest: 1
Epidermal pretest: 2

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
CONCENTRATION OF TEST MATERIAL AND VEHICLE USED AT INDUCTION

0.1 ml for each application:

- 1:1 mixture of Freund's Complete Adjuvant (FCA) in
physiological saline (NaCl)

- 1% test substance in PEG 400
- 1% test substance in a 1:1 mixture of FCA and NaCl

- PEG 400

- 1:1 mixture of PEG 400 in 1:1 mixture of FCA and NaCl

CONCENTRATION OF TEST MATERIAL AND VEHICLE USED FOR EACH CHALLENGE

50% test substance in PEG 400
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
CONCENTRATION OF TEST MATERIAL AND VEHICLE USED AT INDUCTION

0.1 ml for each application:

- 1:1 mixture of Freund's Complete Adjuvant (FCA) in
physiological saline (NaCl)

- 1% test substance in PEG 400
- 1% test substance in a 1:1 mixture of FCA and NaCl

- PEG 400

- 1:1 mixture of PEG 400 in 1:1 mixture of FCA and NaCl

CONCENTRATION OF TEST MATERIAL AND VEHICLE USED FOR EACH CHALLENGE

50% test substance in PEG 400
No. of animals per dose:
10 (Test group)
5 (control group)
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

Positive control results:
Positiv control results were generated in the period from 01.12.1998 to 01.01.1999.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
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: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
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: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
The expected and common findings, as erythema, oedema,
necrotizing dermatitis, encrustation and exfoliation of
encrustation was observed.

Evidence of sensitisation of each challenge concentration:
0% of the animals showed sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on these results and according to the EC criteria for classification and labelling according to DSD (Directive 67/548/EEC) and GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement as skin sensitising.
Executive summary:

As no skin sensitisation was induced in a GLP-study acc. to OECD guideline 406, test item is considered as not skin sensitising.