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Diss Factsheets

Administrative data

Description of key information

The test substance might have sensitizing properties based on skin fold thickness measurements.

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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
additional measurement of skin thickness with cutimeter
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study has been conducted when the LLNA was not yet the standard method.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 0-33178 Borchen, SPF breeding colony.
- Body weight at start of study: 291-405 g
- Age at start of study: 5-8 wk
- Housing: in macrolon cages (type 4) on soft wood granulate
- Diet: Altromin 3022 for guinea pigs, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 8 d
- Animal identification: fur marking and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23°C
- Humidity: 35-60%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: August 24, 1999 To: September 24, 1999
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5% / 0.1 mL
Day(s)/duration:
Day 1 - one injection in water and one injection in water and Freund's Adjuvant
Adequacy of induction:
other: highest possible concentration not leading to complete discolouration of animal
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 8 - for 48 hours
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 22 - for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% / 0.5 mL
Day(s)/duration:
Day 36 - for 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 2 x 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal + 1 epicutaneous
- Exposure period: intradermal: 24 hours; epicutaneous: 48 hours
- Test groups: 1
- Control group: 2
- Site: shoulder
- Frequency of applications: Day 1; Day 8
- Duration: 24 and 48 hours
- Concentrations: 0.5 and 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 22 and Day 36
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1 + 1
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches

as the blue discolouration of the skin did not allow the evaluation of skin reddening, the thicknes of skin folds was measured with a cutimeter before and after challenge treatment to assess for sensitising properties
Positive control substance(s):
yes
Remarks:
formaldehyde
Positive control results:
1. Challenge: 2% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group
2. Challenge: 0.5% formaldehyde - positive effects in the treatment group and to a lesser effect in the control group
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.52 after challenge: 1.66 (test substance flank) = 0.14
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.48 - after challenge: 1.59 (control flank) = 0.11
Remarks on result:
other: skin fold thickness
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.57 - after challenge: 1.84 (test substance flank) = 0.27
Remarks on result:
other: skin fold thickness
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.57 - after challenge: 1.78 (test substance flank) = 0.21
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.53 - after challenge: 1.65 (control flank) = 0.12
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.53 - after challenge: 1.63 (control flank) = 0.10
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.46 - after challenge: 1.59 (test substance flank) = 0.13
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% test substance
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.46 - after challenge: 1.62 (test substance flank) = 0.16
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.45 - after challenge: 1.54 (control flank) = 0.09
Remarks on result:
other: skin fold thickness
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
Total no. in group:
10
Clinical observations:
skin fold thickness: pre-treatment: 1.45 - after challenge: 1.51 (control flank) = 0.06
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.73 - after challenge: 1.84 (test substance flank) = 0.11
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% test substance
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.73 - after challenge: 1.97 (test substance flank) = 0.24
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.67 - after challenge: 1.69 (control flank) = 0.02
Remarks on result:
other: skin fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0
Total no. in group:
20
Clinical observations:
skin fold thickness: pre-treatment: 1.67 - after challenge: 1.74 (control flank) = 0.07
Remarks on result:
other: skin fold thickness
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5%
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.5%
No. with + reactions:
11
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Remarks:
there might be skin sensitising properties based on skin fold thickness measurements
Conclusions:
The test substance might have sensitizing properties based on skin fold thickness measurements.
Executive summary:

A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, in compliance with GLP. Concentrations of the test substance at 5 and 25% in deionized water were selected for the intradermal and dermal inductions. The test substance is a blue dye that strongly colours the skin, making it impossible to evaluate skin irritation reactions such as reddening. Therefore, effects were measured as thickness of a skin fold using a cutimeter. At the first reading (concentration: 10%), differences in skin fold thickness were seen in the treated groups between the treated and control flanks. The difference was notable at 48 h and slightly attenuated at 72 h. These effects between substance and sham-treated sides were less pronounced in the control animals. The second reading (concentration: 10%) yielded similar results. However, the increases in skin fold thickness was less distinctive after 48 h, but was more pronounced at 72 h in the treated group. Under the study conditions, the test substance might have sensitizing properties (Heiman, 1986).

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

A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, in compliance with GLP. Concentrations of the test substance at 5 and 25% in deionized waterwere selected for the intradermal and dermal inductions. The test substance is a blue dye that strongly colours the skin, making it impossible to evaluate skin irritation reactions such as reddening. Therefore, effects were measured as thickness of a skin fold using a cutimeter.

Skin thickness after 1stChallenge

Group

Dose level [%]

Skin-fold thickness [mm]

Difference to pre-treatment [mm]

pre-treatment

48 h reading

72 h reading

48 h

72 h

Negative control

0

1.48

1.59

1.59

0.11

0.11

10

1.52

1.66

1.66

0.14

0.14

Test group

0

1.53

1.65

1.63

0.12

0.10

10

1.57

1.84

1.78

0.27

0.21

Skin thickness after 2ndChallenge

Group

Dose level [%]

Skin-fold thickness [mm]

Difference to pre-treatment [mm]

pre-treatment

48 h reading

72 h reading

48 h

72 h

Negative control

0

1.45

1.54

1.51

0.09

0.06

10

1.46

1.59

1.62

0.13

0.16

Test group

0

1.67

1.69

1.74

0.02

0.07

10

1.73

1.84

1.97

0.11

0.24

At the first reading (concentration: 10%), differences in skin fold thickness were seen in the treated groups between the treated and control flanks. The difference was notable at 48 h and slightly attenuated at 72 h. These effects between substance and shame treated sides were less pronounced in the control animals. The second reading (concentration: 10%) yielded similar results. However, the increases in skin fold thickness was less distinctive after 48 h, but was more pronounced at 72 h in the treated group.Under the study conditions, the test substance might have sensitizing properties (Heiman, 1986).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of an in vivo guinea pig maximisation test, a classification of Category 1B for skin sensitization is required for the test substance according to CLP (EC 1272/2008) criteria.