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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From March 6 to April 4, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Source study has reliability 1. Details on the read across are attached in section 13.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.

Test material

Constituent 1
Reference substance name:
Similar Substance 03
IUPAC Name:
Similar Substance 03
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH
- Weight at study initiation: 263 - 350 g
- Housing: in groups of 5 per Type IV Makrolon cage
- Diet: Kliba rabbit and guinea pig maintenance diet (341.4 mm); ad libitum.
- Water: tap water (drinking water with about 2g of ascorbic acid in 10 I water twice a week); ad libitum.
- Acclimation period: not less than 6 days before the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
intradermal: 5 %
epicutaneous: 50 %
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
20 %
No. of animals per dose:
Test group: 20
Each control group: 10
Details on study design:
RANGE FINDING TESTS:
- Administration volume: filter paper strips of 2 × 2 cm edge length were allowed to take effect in the region of the flank under occlusive conditions.
- Exposure time: the test substance was administered for 2 × 24 hours within a period of 96 hours in order to detect unspecific phenomena which are not based on a sensitization reaction but which might displace the irritation threshold.
- Site of administration: region of the flank, in each case in the same place.
- Number of animals: 4 for each test concentration.
- Readings: approximately 24 and 48 hours after the start of administration.

MAIN STUDYA. INDUCTION EXPOSURE: INTRADERMAL INDUCTION
- No. of exposures: 6 intradermal injections, two at a time, for each animal.
- Exposure period: single application.
- Two control groups: the animals received the same injections, but without the test substance and only with the agent which was used for preparing the suspension.
- Site: shoulder region
- Concentrations: 5 %

B. INDUCTION EXPOSURE: EPICUTANEOUS INDUCTION
- Time schedule: one week after intradermal induction
- Exposure: liquid immersed filter paper strips of 2 × 4 cm edge length under occlusive conditions.
- No. of exposures: 1
- Exposure period: 48 h
- Site: shoulder region, in the same area as previously with the intradermal application.
- Concentrations: 50%

C. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: the first dose approximately 14 days after the epicutaneous induction, the second dose one week later.
1st challenge: test group and control group 1 (control group 2 untreated);
2nd challenge: test group and both control groups.
- Exposure: liquid immersed filter paper strips of 2 × 2 cm length under occlusive conditions.
- Exposure period: 24 h
- Site: intact clipped region of the flank.
- Concentrations: 20 %
- Evaluation: approximately 24, 48, 72 hours after the start of administration.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control group 2
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control group 2
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects

Any other information on results incl. tables

1/10 animals of control group 1 died 4 days after intradermal induction.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
No sensitising potential.
Executive summary:

Method

The substance was tested for sensitising effects on the skin of the guinea pig in a maximisation test, according to OECD guideline 406. Induction was done by intradermal route and by epicutaneous route using concentrations of 5 % and 50 %, respectively. Epidermal challenge was done by applying test substance at a concentration of 20 %.

Results

After the challenge application, no cutaneous reactions were observed in animals of both control and test groups at the 24-hour and 48-hour readings.

Therefore, test substance did not show any sensitising potential.