Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vivo (guinea pig maximisation test)
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 2; details on the read-across approach are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Test based on method described by Magnusson B. and Kligman A.M. in 'Allergic contact dermatitis in the guinea pig: identification of contact allergens', C.C. Thomas, Springfield, Illinois, 1970.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pribright white
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Stock, Gelnhausen
- Housing: 10 animals per cage
- Diet: ad libitum
- Water: ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Freund's complete adjuvant 50 : 50 in distilled water.
Concentration / amount:
1 %
Day(s)/duration:
day 0
Route:
intradermal
Vehicle:
water
Concentration / amount:
1 %
Day(s)/duration:
day 0
Adequacy of induction:
other: highest non irritant concentration
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
75 %
Day(s)/duration:
day 7 / exposure period 48 h
Adequacy of induction:
other: highest non irritant concentration
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10 %
Day(s)/duration:
day 21 / exposure period 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals.
Details on study design:
RANGE FINDING TESTS: highest non irritating concentration tested and adopted for main test were: 1 % in distilled water for intradermal injection; 75 % in paraffin for dermal application; 10 % in distilled water for dermal challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injection
- no. of exposure: 1.
- area: 4 × 6 cm on shaved shoulder.
- 3 types of injections, each in left and right side of the area: 1) Freund's complete adjuvant 50 : 50 with distilled water; 2) 1 % test substance in distilled water; 3) Freund's complete adjuvat 50 : 50 with 1 % test substance in distilled water.

Dermal application
- no. of exposure: 1.
- day of exposure: 7 days after intradermal injection.
- area: 3 × 6 cm.
- exposure period: 48 hours.
- concentration: 75 % in paraffin.
- coverage: closed.

B. CHALLENGE EXPOSURE
Dermal application
- day of challenge: 14 days after dermal application.
- exposure period: 24 hours.
- concentration : 10 % in distilled water.
- coverage: closed.
- site: left flank.
- evaluation: 24, 48 and 72 hours after challenge.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 % in distilled water
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
slight oedema
Remarks on result:
other: slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 % in distilled water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
10 % in distilled water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

animal E = erythema O = oedema observation time h
24 48 72
1 E  0 0 0
O 0 0 0
2 E  0 0 0
O 0 0 0
3 E  0 0 0
O 0 0 0
4 E  0 0 0
O 0 0 0
5 E  0 0 0
O 0 0 0
6 E  0 0 0
O 1 0 0
7 E  0 0 0
O 0 0 0
8 E  0 0 0
O 0 0 0
9 E  0 0 0
O 1 0 0
10 E  0 0 0
O 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance resulted as non sensitising in guinea pig maximisation test.
Executive summary:

Method

Guinea pig maximisation test according to method described by Magnusson and Kligman, 1970. Preliminary test allowed to choose concentrations for the main test. In particular, at day 0, induction was done by intradermal injection of test substance at 1 % concentration in distilled water and 50 : 50 distilled water and Freund's adjuvant; at day 7, induction was done by a 48 -h occlusive dermal application of test substance at 75 % concentration in paraffin ; at day 21, challenge was performed by a 24 -hour occlusive dermal application of test substance at 10 % in distilled water.

Results

Examination of treated areas was performed 24, 48 and 72 hours upon challenge exposure. 2/10 positive responses in terms of oedema were found at the 24-hour observation, then no positive responses were seen.