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Diss Factsheets

Administrative data

Description of key information

Guinea Pig Maximization test (GLP, OECD TG 406): sensitizing (Vohr, 2001)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb - June 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Guinea Pig Maximization Test according to Magnusson and Kligman
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 2001 before implementation of the LLNA (in 2002).
Specific details on test material used for the study:
purity 95.7%
Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 5%
intradermal induction: 100%
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
100%
No. of animals per dose:
20 in the test item group
10 in the control group
Details on study design:
Intradermal Induction: The dorsal region and the flanks of the guinea pigs were shorn one day prior to the application. Starting behind the nape of the neck, three injections each in a row were made on the left and the right side of the spinal column. The 1st and 2nd injections were made as contiguous as possible and the 3rd injections in a distance of about 2 cm from the 2nd. The volume applied per injection site was 0.1 ml.
The topical induction was performed one week after the intradermal induction. On the day prior to topical treatment, the test areas of the animals were shorn. Hypoallergenic patches (2x4 cm) were placed between and on the injection sites, covered with aluminum foil and held securely in place on the skin using a ORABAND® self-adhesive tape (Fa. Orafol). At the end of the 48-hour exposure period, the remaining test item was removed with sterile physicological saline solution and the treatment areas were visually assessed.
The challenge was performed three weeks after the intradermal induction. In the meantime, the test item concentrations for the challenge had been determined in a dose range-finding study using 2 guinea pigs that were treated during the inductions in the same manner as the control animals. The dorsal region and the right flank of the animals were shorn one day prior to the challenge. During the challenge a hypoallergenic patch loaded with the 0.5% test item formulation was placed on the right flank (caudal) of the animals of the test item group and the control group and held securely in place on the skin with a ORABAND® self-adhesive tape for 24 hours. A patch loaded only with the vehicle was placed also on the right flank (cranial) as control. The volume applied in each case was 0.5 ml. At the end of the exposure period, the remaining test item was removed with physiological saline solution, and 21 hours later the skin of the animals was shorn in the zone of the challenge area.
Positive control substance(s):
yes
Remarks:
Alpha-Hexylzimtaldehyde tested in a separate study (Report PH 30207)
Positive control results:
Reliability of the Method (Report PH 30207, Vohr, 2000; Validation of the test method):
The Guinea Pig Maximization Test methodology was checked for reliability in a test on female guinea pigs using alpha-Hexylzimtaldehyd formulated in sterile physicological saline solution at the concentrations indicated below:
For the intradermal induction a 5% test item formulation was used, and for the topical induction a 25% formulation. After the challenge with a 12% test item formulation 100% of the test animals exhibited dermal reactions in the challenge treatment. There was no reddening of the skin to be observed on control group animals. The sensitivity as well as the reliability of the experimental technique is thus confirmed by this study.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
12%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
skin reactions grade 1-3
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
12%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
skin reactions grade 0-1
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 16.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
sensitizing
Executive summary:

The Guinea Pig Maximization Test (GPMT) was performed in 2001 on 30 female guinea pigs (20 animals for the test item group and 10 control animals) to determine whether the test item JAU 6476-METHYLKETON (purity: 95.7%) exhibits skin sensitizing properties. Additional two animals were used for dose-finding.The study was conducted according to OECD Guideline No. 406/EC Guideline
96/54/EC (22th Adaptation of Guideline 67/548/EEC)/Health Effects Test Guideline, OPPTS 870.2600 with the following test item concentrations:
Intradermal induction: 5%
Topical induction: 100%
Challenge: 100%
The test item was formulated in com oil to yield a solution.
The challenge with the 100% test item led to skin effects (grade 1 - 3) in 16 of 20 animals (80%) in the test item group and no skin effects were seen in the control group animals.
In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits a skin-sensitization potential.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results the test-item needs to be classified as Cat. 1B skin sensitizer according to Regulation (EC) 1272/2008 .


(H317: May cause an allergic skin reaction)