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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
Study period:
October 02 - 25, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.6 Maximisation Study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Nikkol VC-IP
- Substance type: Colourless to light yellow transparent liquid
- Physical state: Liquid
- Stability under test conditions: stable
- Storage condition of test material: In refrigerator in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 5 weeks
- Body weight prior to start: maximal 500 grams
- Housing: 5 animals per labelled metal cage with wire-mesh floors
- Diet: LC 23-B, pellet diameter 4mm (Hope farms, Woerden, The Netherlands), including ascorbic acid (1600 mg/kg)
- Water: tap-water, diluted with decalcified water. Certificates of quarterly analysis for tap-water were examined and retained in the NOTOX archives
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 100%

Epidermal: 100%

Concentration of test material and vehicle used for each challenge:
Epidermal: 100%
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 100%

Epidermal: 100%

Concentration of test material and vehicle used for each challenge:
Epidermal: 100%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Intradermal injections:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be
injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The resulting dermal
reactions were assessed 24 and 48 hours after treatment.
Epidermal application:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be
applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Scotchpak-non-woven patches* (2x3 cm) onMicropore tape* and held in place by Coban elastic bandage*. The animals receiving intradermal injections were treated with the lowest
concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of
residual test.
substance. The resulting dermal reactions were assessed for irritation 24 and 48
hours after exposure.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
100 %
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: 100 %. 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.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
0/10

Evidence of sensitisation of each challenge concentration:
8/10

Other observations:
The substance showed a sensitisation rate of 80%

Scaliness was seen in a treated skin site of one animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The skin reactions observed in response to the undiluted test substance in eight (of the ten) experimental animals in the challenge phase were
considered indicative of sensitisation, based on the absence of any response in the control animals.
These results indicate a sensitisation rate of 80 per cent.
Applying the allergenicity rating described by Kligman A.M. (1966) to the results obtained in this test, NIKKOL VC-IP is considered to have strong
sensitising properties.