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Diss Factsheets

Administrative data

Description of key information

OECD 406, guinea pig: sensitising (reference 7.4.1 -1)

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:
1990-09-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
OET (Open Epicutaneous Test)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1990 when the LLNA was not an established test method yet.
Species:
guinea pig
Strain:
other: gpg, Iva:PDH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation: 5 weeks
- Weight at study initiation: mean 300 g (range: 237 - 349 g)
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 30 °C
- Humidity: 38 - 70 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light
Route:
other: open epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
0 % (control)

3 % (1. challenge group)

10 % (2. challenge group)
Route:
other: open epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
a) 1. Challenge: 0, 1 %, 3 % und 10 % in Paraffin

b) 2. Challenge: 0, 1 %, 3 % und 10 % in Paraffin
No. of animals per dose:
Number of animals in test group: 6
Number of animals in negative control group: 6
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: once daily for 21 days
- Exposure period: topical application; no washing
- Test groups: 2
- Control group: 2
- Site: back
- Frequency of applications: once daily
- Concentrations: 3 and 10 %

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22 and day 36
- Exposure period: topical application; no washing
- Test groups: 2
- Control group: 2
- Site: left or right flank
- Concentrations: 1, 3, and 10 %
- Evaluation: 24, 48, 72 h after administration

Challenge controls:
yes
Positive control substance(s):
no
Positive control results:
not applicable
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
4
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
3
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
6
Key result
Group:
positive control
Remarks on result:
not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 3 %
Evidence of sensitisation of each challenge concentration:
Challenge 1: no animal assessed as sensitizing
Challenge 2: 4/6 and 3/6 respectively

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Based on the findings of this study, the test item is considered a skin sensitiser.
Executive summary:

The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Four groups with 6 female guinea-pigs, each, were investigated:

Group 1 and group 2 were controls. Group 3 was treated with 0.1 mL of 3 % test item,

and group 4 with 0.1 mL of 10 % test item during the 21 day induction phase.

During this period erythema and/or scales were observed at the treated skin sites in groups 2-4. After the first challenge on day 22 with 1, 3, and 10 % test material concentrations, only one animal of group 3 showed a skin reaction to the 3 % preparation. After the second challenge with the same concentrations, skin reactions to the vehicle or to the test material were seen in some animals of all groups. Sensitization, however, was only indicated in group 3 to the 3 % and 10 % test material preparations. The test item should therefore be classified as a sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Open epicutaneous test in guinea pigs, reference 7.4.1 -1

The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Four groups with 6 female guinea-pigs, each, were investigated:

Group 1 and group 2 were controls. Group 3 was treated with 0.1 mL of 3 % test item,

and group 4 with 0.1 mL of 10 % test item during the 21 day induction phase.

During this period erythema and/or scales were observed at the treated skin sites in groups 2-4. After the first challenge on day 22 with 1, 3, and 10 % test material concentrations, only one animal of group 3 showed a skin reaction to the 3 % preparation. After the second challenge with the same concentrations, skin reactions to the vehicle or to the test material were seen in some animals of all groups. Sensitization, however, was only indicated in group 3 to the 3 % and 10 % test material preparations. The test item should therefore be classified as a sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation the test item is classified and labelled as skin sensitiser cat 1 (H317: "May cause an allergic skin reaction") according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.