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Diss Factsheets

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:
04 September 1984 to 23 November 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test was carried out according to the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969), recommended in the OECD guidelines 1981 and in the EEC directive 79/831. The test also has a good documentation but without GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
other: EEC directive 79/831
Deviations:
not specified
GLP compliance:
no
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

Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test material: FAT 20'306/B; Batch No. HT 2025/50
Purity: >96 %
Appearance: powder
Storage conditions: room temperature
Validity: 2014

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White strain
Sex:
male/female
Details on test animals and environmental conditions:
The guinea pigs were recognized by the international guideline as the recommended test system.
- Animal strain: Guinea pigs of the Pirbright White strain (Tif:DHP)
- Age at study initiation: 10 weeks
- Weight at study initiation: 301 - 401 g
- Housing: individually in Macrolon cages
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG - and fresh water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Humidity (%): 50 ±10
- Photoperiod (hrs dark / hrs light): on a 14 hours light cycle day.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1st dose: mixture of adjuvant and saline; 2nd dose: Saline
Concentration / amount:
Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound FAT 20'306/B in saline and with the test compound FAT 20'306/B in the adjuvant saline mixture.
Day(s)/duration:
Day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
One week later FAT 20'306/B was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours)
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
30 % ~0.2 g per patch
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
The test was performed on 10 male and 10 female guinea pigs per group.
Details on study design:
Induction, intradermal application:
Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound FAT 20'306/B in saline and with the test compound FAT 20306/B in the adjuvant saline mixture.

Induction, epidermal application:
One week later FAT 20'306/B was incorporated in Vaseline and applied on a filter paper patch to the neck of the animals (occlusive administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).

Challenge:
Two weeks after the epidermal induction application the animals were tested on the flank with 30 % FAT 20'306/B in Vaseline and the vehicle alone (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, ~5 minutes). A second evaluation is made 48 hours after removing the dressings. The concentrations of the test compound for induction and challenge periods were determined on separate animals. 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 compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Challenge controls:
vehicle - vaseline
Positive control substance(s):
yes
Remarks:
p - phenylenediamine

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20306/B is not considered as sensitising to skin in GPMT study.
Executive summary:

The guinea pig maximisation test was carried out with FAT 20306/B in guinea pigs to assess the allergenic potential of test article according to the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969), recommended in the OECD guidelines 1981 and in the EEC directive 79/831. The test was performed on 10 male and 10 female guinea pigs per group. The sensitivity of the strain is controlled every six month with p-phenylenediamine.


Induction, intradermal application:


Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound FAT 20306/B in saline and with the test compound FAT 20'306/B in the adjuvant saline mixture.


Induction, epidermal application:


One week later FAT 20306/B was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).


Challenge:


Two weeks after the epidermal induction application the animals were tested on the flank with 30 % FAT 20306/B in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, ~5 minutes). A second evaluation is made 48 hours after removing the dressings. The concentrations of the test compound for induction and challenge periods were determined on separate animals. 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 compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. FAT 20306/B, at the concentration of 30 % in vaseline, did neither induce edema nor erythema reactions after epidermal challenge application. No toxic symptoms were evident in the guinea pigs of either the control and test group. No death occurred. Therefore, it indicates that test article shall not be classified in accordance with CLP (Regulation EC No.1272/2008).