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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 5, 1993 to December 10, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Test Article: FAT 31016/P
- Additional specification: Maxilonrot GRL BR,ro trocken
- Batch No.: 414154.32
- Contents/Purity: 95%
- Physical properties: solid; red-brown powder
- Storage conditions: room temperature
- Validity: July, 1998
- Test article received: September 1, 1993

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 327 to 391 g
- Housing: individually in Macrolon cages
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30 to 70%
- Photoperiod: 12 hours light cycle day
- IN-LIFE DATES: From: October 11, 1993 To: November 5, 1993

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Day(s)/duration:
Day 0
Adequacy of induction:
other: this concentration was well tolerated when injected intradermally
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
Day 8
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 males and 10 females in the test groups
5 males and 5 females in the control group
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE - Intradermal
- No. of exposures: 1
- Site: neck
- Frequency of applications: once only
- Concentrations: 5 %

B. INDUCTION EXPOSURE - Epidermal
- No. of exposures: 1
- Site: neck
- Frequency of applications: once only
- Concentrations: 50 %
- Exposure period: 48 hours

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Site: flanks
- Concentrations: 50 %
- Evaluation (hr after challenge): 24 and 48 hours after removing the dressings
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss

Results and discussion

Positive control results:
90 % of the exposed animals exhibited positive reactions.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 % : intradermal induction, 50 %: epidermal induction, 50 %: epidermal challenge
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 % : intradermal induction, 50 %: epidermal induction, 50 %: epidermal challenge
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Under the experimental conditions employed, 100% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
FAT 31016/P was found to have strong sensitisation potential in the guinea pig maximisation test.
Executive summary:

A sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency of FAT 31016/P. This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).

The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively, initially weighing between 327 to 391 g. The test group animals were given test substance at 5 % (in physiological saline) during the intradermal induction phase, while exposed to 10 % SDS + 50 % test substance (in vaseline) at the epidermal induction phase. The test as well as control animals were then challenged with a epidermal application of the test substance at 50 % concentration (in vaseline). Under the experimental conditions employed, 100% (20/20) of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, FAT 31016/P was concluded to have strong sensitisation potential in the guinea pig maximisation test.