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Administrative data

Description of key information

Based on the negative results of a Magnusson-Kligman Sensitisation Assay the substance is considered not to be skin sensitising.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, limited documentation, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive control group included / reduced minimal number of animals in the negative control group used (4 instead of 5 - 10)
Principles of method if other than guideline:
according to Magnusson B and Kligman AM (1970) in "Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens", Springfield, Illinois/USA
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was performed before LLNA method was established.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Redfern Animal Breeders Ltd., Brenchley/Kent
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: suspended cages with a wire-mesh floor
- Diet: ad libitum
- Water: ad libitum
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
induction/i.d.: 0.1 % (v/v); induction/topical: 5 % (v/v)
challenge/topical 0.5 % (v/v)
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
induction/i.d.: 0.1 % (v/v); induction/topical: 5 % (v/v)
challenge/topical 0.5 % (v/v)
No. of animals per dose:
20 (test); 4 (control)
Details on study design:
RANGE FINDING TESTS:
Test on intradermal and topical irritancy

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge):


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x i.d.; 1x topical
- Exposure period: i.d. followed by 1 wk rest period; topical: 48 h , followed by 14 d rest period
- Test group: 3 pairs of i.d. injections (A. Freund´s complete adjuvant / B. TS in liquid paraffin / C. Combination of A. and B.)
Topical application: 2x4 cm strip of Whatman No.1 MM paper soaked with the TS in paraffin, placed over the injection sites.
- Control group: one (4 animals) - no induction treatment (no details given)
- Site: interscapular area (right and left flank)
- Duration: 3 weeks
- Concentrations: 0.1 % (i.d.); 5 % (topical)


B. CHALLENGE EXPOSURE
- No. of exposures: 1x
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test groups: 2x2 cm Whatman No.1 MM paper soaked with the TS in paraffin applied to the the untreated right flank,
another paper without TS applied to the untreated left flank.
- Control group: analogous to the test group
- Site: see above
- Concentrations: 0.5 % (v/v)
- Evaluation (hr after challenge): 24, 48, and 72 h


OTHER:
Positive control substance(s):
no
Positive control results:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
other:
Group:
positive control
Total no. in group:
0
Remarks on result:
not measured/tested

Induction

I.d. injections of FCA both alone and mixed with the TS elicited slight dermal irritation (data not shown). No dermal irritation was observed following i.d. injections of the TS (0.1% in paraffin oil) alone.

Reactions produced by the topically applied TS (5 % in paraffin oil) were obscured by the i.d. reactions which were still present at that time.

Challenge

no dermal irritation occurred on either flank of any of the test and control animals.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this test the test substance did not show sensitising properties.
Executive summary:

The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406. Intradermal induction was performed with 0.1% v/v test substance while 5% v/v in liquid parrafin was used for topical application. No dermal irritation was observed following intradermal injections alone. Reactions produced by the topical application were obscured by the intradermal reactions which were still present at this time. The animals were challenged topically two weeks after the induction period using 0.5% v/v in liquid paraffin. No dermal irritation occured on either flank of any of the guinea-pigs during the challenge period. There was, therefore, no evidence of delayed-type skin sensitivity.

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

In a Magnusson & Kligman test according to OECD Guideline 406, performed in twenty albino guinea-pigs, the test substance did not produce any evidence of delayed-type skin hypersensitivity.

Justification for classification or non-classification

Based on the available experimental results the substance has not to be classified as skin sensitising according to Regulation (EC) No. 1272/2008.