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Diss Factsheets

Administrative data

Description of key information

Not sensitising in a Guinea pig maximisation test.

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:
From March 10 to June 3, 1994
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
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Guine pig maximisation test was available.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: at delivery, no parasites, pathogenic microorganisms, viruses and fungi
- Weight at study initiation: 300 - 385 g
- Housing: group of 5 per cage
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Controlled temperature
- Controlled humidity
- Air changes: automatic ventilation
- Photoperiod: 12 hrs light
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5 % in water
0.5 % in complete Freund's adjuvant in water 1:1
Day(s)/duration:
day 0
Adequacy of induction:
other: highest concentration causing no skin irritation
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
25 %
Day(s)/duration:
48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Details on study design:
RANGE FINDING TESTS: animals were exposed epicutaneously to test substance, using a filter paper saturated with 0.5 %, 1 % and 5 % solutions of water for injection, fixed by an occlusive bandage for 24 hours.
1 hour after removal of the bandage and sample, local irritation was evaluated and it was found that 0.5 % in water for injection was not irritating to guinea pigs, whil weak signs of irritation were noted at the 2 highest concentrations..

MAIN STUDY
A. INDUCTION EXPOSURE: intradermal
- Test groups: 20 females
- Control group: 10 females
- Site: shaved neck area
- Frequency of applications: 3 injections of 0.1 ml
- Duration: on day 0
- Concentrations: Freun'd complete adjuvant; 0.5 % test substance in water; 0.5 % test substance in 1:1 water and complete Freund's adjuvant

A. INDUCTION EXPOSURE: epicutaneous
- Test groups: 20 females
- Control group: 10 females
- Site: shaved neck area
- Frequency of applications: 1
- Duration: on day 7, for 48 hours
- Concentrations: 25 % in vaseline

B. CHALLENGE EXPOSURE 1: epicutaneous
- Day of challenge: 20
- Exposure period: 24 h
- Test groups: 20 females
- Control group: 10 females
- Site: right flank
- Concentrations: 0.5 %
- Evaluation: 1, 24, 48 and 72 h after removal of the bandage

B. CHALLENGE EXPOSURE 2: epicutaneous
- Day of challenge: 27
- Exposure period: 24 h
- Test groups: 20 females
- Control group: 10 females
- Site: left flank
- Concentrations: 0.5 %
- Evaluation: 1, 24, 48 and 72 h after removal of the bandage and washing with water to eliminate residues
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: not reported

Primary dermal irritation test

concentration erythema oedema
5% 1 2
1 1
1% 1 1
1 1
0.5 % 0 0
0 0
25% in vaseline 2 3
1 2

0       without reaction
1       very weak erythema, very weak oedema
2       weak erythema, weak oedema
3       mean erythema, mean oedema
4       strong erythema, strong oedema

Negative controls

No signs of irritation in terms of erythema and/or oedema were noted after first and second challenge in negative controls.

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
Non skin sensitising.
Executive summary:

Method

Guinea pig maximisation test using 20 females in test group and 10 females in control group. Intradermal induction was done on day 0 using a 0.5 % solution of test substance. This concentration was chosen in a preliminary test using water solutions at 0.5 %, 1 % and 5 %. Epidermal induction was done on day 7, using a 0.5 % solution of test substance. First epidermal challenge was conducted on day 20, by occlusive epicutaneous application of a 0.5 % solution of test substance for 24 hours. Evaluation for responses was carried out 1, 24, 48 and 72 hours after removal of the bandage. A second epidermal challenge was carried out on day 27 to avoid false negative results, under the same test conditions.

Results

The 0.5 % solution was found to be the highest non irritating concentration tested in the preliminary test on irritation. Upon challenge, on day 20 and on day 27, no positive responses were reported, in both test group and control group.

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

No positive responses were found in guinea pigs in a maximisation test using OB 134 according to OECD guideline 406.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 is considered as positive.

Under the experimental conditions employed, 0 % of the animals of the test and control groups showed skin reactions 24, 48 and 72 hours upon challenge with test substance at 0.5 % concentration, thus no classification applied.