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Description of key information

A guinea pig maximization study was conducted to determine the skin sensitisation potential of FAT 20077/C, according to OECD Guideline 406 and EEC Directive 79/83 with deviations. Based on the findings of a pre test, FAT 20077/C was used at 5, 50 and 30 % concentrations for intradermal induction, epidermal induction and epidermal challenge respectively. Following challenge, 20 % and 15 % of the animals of the test group showed skin reactions, 24 and 48 hours after removing the dressings, respectively. Hence, according to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993), FAT 20077/C did not show any skin-sensitising (contact allergenic) potential in albino guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 10 March, 1988 to 14 July, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in May 12, 1981
Deviations:
yes
Remarks:
Numbering of ear tags: By technical error the same ear tag numbers have been used for the identification of the t e s t group animals of both series, A and B.
Qualifier:
according to guideline
Guideline:
other: 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
Deviations:
yes
Remarks:
Numbering of ear tags: By technical error the same ear tag numbers have been used for the identification of the t e s t group animals of both series, A and B.
Principles of method if other than guideline:
None
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.
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 LTD. Tierfarm, 4334 Sisseln, Switzerland
- Weight at study initiation: 335 to 421 g
- Housing: Housed individually in Macrolon cages
- Diet: Standard guinea pig pellets- NAFAG No. 846, Gossau SG, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 1 week

SENSITIVITY OF STRAIN
- The sensitivity of the strain is checked once or twice a year w ith a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h light/12 h dark
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 %
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
30 %
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Main test: 10 control animals and 20 treated animals (10 males and 10 females).
Details on study design:
Pretests
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest.
The following concentration of test article has been used for intradermal injection:
5% in physiological saline (w/v).
Since 5% FAT 20077/C in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.

Epidermal Applications (induction and challenge):
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 20077/C have been examined on separate animals for the determination of the maximum subirritant concentration.

30 and 50% in physiological saline:
50% was the highest possible concentration of the test article in physiological saline. Reactions were observed with 50% FAT 20077/C in physiological saline.

MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
- First induction, intradermal injection: Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the animals as follows:
- adjuvant and saline (1:1)
- test substance in physiological saline-5%
- test substance in the adjuvant/saline mixture-5%
Control group- physiological saline and adjuvant mixture: 1:1 (V/V
- Second induction, epidermal application: One week later test substance was incorporated in physiological saline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm2; occluded administration for 48 h).
- 50% FAT 20077/C in physiological saline

B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with test substance in Vaseline and the vehicle alone (patch 2 x 2 cm²; occluded administration for 24 h).
Dose of application: 30% of substance in physiological saline
The concentrations of the test substance for the induction and challenge periods were determined on separate animals.
Control group: A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test substance (at least 10 animals) to control the maximum sub-irritant concentration of the test substance in adjuvant treated animals.

OBSERVATIONS:
24 h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The sensitizing potential of the test substance was classified according to the grading of Magnusson and Kligman. The body weight was recorded at start and end of the test.
Challenge controls:
Not available
Positive control substance(s):
yes
Positive control results:
All 20/20 animals were affected after occlusive epidermal application in positive control animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction- Intradermal 5 %, Epidermal 50 %, Challenge: 30 % epidermal application
No. with + reactions:
4
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction- Intradermal 5 %, Epidermal 50 %, Challenge: 30 % epidermal application
No. with + reactions:
3
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Test article control
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Test article control
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2-Mercaptobenzothiazole puriss: Intradermal induction 5%, Epidermal induction 50%, Epidernal challenge 30%
No. with + reactions:
20
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2-Mercaptobenzothiazole puriss: Intradermal induction 5%, Epidermal induction 50%, Epidernal challenge 30%
No. with + reactions:
20
Total no. in group:
20

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20077/C is not to be classified as skin sensitiser.
Executive summary:

A guinea pig maximization study was conducted to determine the skin sensitisation potential of FAT 20077/C, according to OECD Guideline 406 and EEC Directive 79/83 with deviations. Based on the findings of a pre test, FAT 20077/C was used at 5, 50 and 30% concentrations for intradermal induction, epidermal induction and epidermal challenge respectively. Following challenge, 20% and 15% of the animals of the test group showed skin reactions, 24 and 48 hours after removing the dressings, respectively. Hence, according to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993), FAT 20077/C did not show any skin-sensitising (contact allergenic) potential in albino guinea pigs.

Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

None

Justification for classification or non-classification

According to the guideline "labelling of dangerous substances" and the criteria for the choice of sentences indicating particular hazards attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993) a test article is classified as a sensitiser in the case where a positive response is noted in at least 30 % of the animals. Hence, according to the EC Regulation (EC) No. 1272/2008, FAT 20077 is not to be classified as a skin sensitizer.