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Diss Factsheets

Administrative data

Description of key information

Not skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 1. Details on the read across are attached in section 13.
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 available, which would not justify conducting an additional LLNA due to animal welfare.
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: ad libitum
- Water: tap water, 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
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
intradermal: 5 %
epicutaneous: 50 %
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 STUDY
A. 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.
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

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

Interpretation of results:
GHS criteria not met
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

As no data on target substance was available, skin sensitising potential was assessed using a read across approach. Similar Substance 01 was used as read across substance and further details were reported in section 13.


Similar Substance 01 was tested for skin sensitising effects in the guinea pig maximisation test according to OECD guideline 406. After challenge, no cutaneous reactions were noted in control and test animals at the 24 -hour and 48 -hour reading.


Such result was confirmed by available data on another structural analogue of target substance, belonging to the same class of dyes and sharing most of the functional groups. In particular, an assay with the LLNA:BrdU-ELISA method, described in OECD guideline 442B, was available. A preliminary test was run using concentration between 1 and 25% to identify a non toxic and minimally irritant concentration. A concentration of 25% was selected as highest concentration for the main assay. The main test was run with concentrations of 5, 10 and 25% w/w in acetone:olive oil 4:1 (v/v).


No mortality, clinical signs or significant changes in bodyweight were noted in the main assay. No increase in cell proliferation of draining lymph nodes occurred at all doses with SI of 0.92 at 5%, 0.88 at 10% and 0.74 at 25%. Neither correlation with the doses nor statistical significance was noted, thus no sensitising potential was associated to test substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin sensitiser is a substance that will lead to an allergic response following skin contact.


In case of a guinea pig maximisation test, a response of at least 30% of the animals, responding at > 1% intradermal induction, is considered as positive. Under the experimental conditions employed, no animals of the test group showed skin reactions 24 and 48 hours upon challenge with test substance at 5% concentration.


Moreover, in a LLNA, a stimulation index > or = 3 is considered as a positive response. Under experimental conditions adopted in a LLNA, all tested concentrations produced a stimulation index below 1.6.


Based on available experimental findings, no classification applied to the substance.