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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:
from Sep. 4, 1984 to Nov. 23, 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:
The study have been performed before the REACh legislation enters into force.
The test was performed in 1984 (before REACh ligislation).

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test substance: FAT 20'306/B
Batch No.: HT 2025/50
Physical properties: 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 (e.g. ad libitum): ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG - and fresh water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2 degree centigrade
- 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: vaseline
Concentration / amount:
Induction (intradermal application): 1 % for intradermal application in physiological saline and saline adjuvant mixture
Induction (epidermal application): 30 % for epidermal application (Induction) in vaseline, ~0.4 g per patch
Challenge: 30 % for epidermal application (Challenge) in vaseline, ~0.2 g per patch
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Induction (intradermal application): 1 % for intradermal application in physiological saline and saline adjuvant mixture
Induction (epidermal application): 30 % for epidermal application (Induction) in vaseline, ~0.4 g per patch
Challenge: 30 % for epidermal application (Challenge) in vaseline, ~0.2 g per patch
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 20'306/B in the adjuvant saline mixture.

Induction, epidermal application:
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). 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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.

Any other information on results incl. tables

Incidence of positive animals per group after occlusive epicutaneous administration

No. of positive animals / No. of treated animals

after 24 hours

- Control group, vehicle application 0/20

- FAT 20'306/B 0/10

- Test group, FAT 20'306/B 0/20

- vehicle application 0/20

after 48 hours

- Control group, vehicle application 0/20

- FAT 20'306/B 0/10

- Test group, FAT 20'306/B 0/20

- vehicle application 0/20

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
FAT 20'306/B, at the concentration of 30 % in vaseline, did neither induce edema nor erythema reactions after epidermal challenge application.
Therefore, the test article shall not be classified in accordance with CLP (Regulation EC No.1272/2008).
Executive summary:

The test was carried out with Guinea pigs to assess the allergenic potential of test articles 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 sensitivity of the strain is controlled every six month with p-phenylenediamine. FAT 20'306/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).