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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation:

A dermal sensitization test was conducted according OECD TG 406. Two groups of guinea pigs (10 vehicle control, 20 test) were included. On day 0, the test group animals were given a set of intradermal

injections (including 1.0% test item in peanut oil). The epidermal inductionapplication was made on day 8; the vehicle control animals were treated with the vehicle alone, and the test animals with 100% (undiluted) test item. The epidermal challenge application on day 21 consisted of a paired application of the vehicle alone and 5.0% test item in peanut oil in both groups. Skin reactions on both the vehicle and test flanks were scored 24 and 48 hours after completion of the challenge application, according to the Draize scale.

There were no positive skin responses among either the vehicle control or test group animals on either the vehicle flank or the test flank; the sensitization rate for the test item was therefore 0%. There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.

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:
June - July 1998
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:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximisation test was performed in accordance to the OECD guideline 406 and can be considered as a validated and reliable testing method for skin sensitization including a high statistical sample size and the challenge phase.1998 the GPMT was the generally accepted in vivo model for the assessment of the skin sensitisation potential of substances in science and regulatory context. The adoption of the LLNA as a new Test Guideline is dated 24th April 2002.
Species:
guinea pig
Strain:
other: Himalayan Spotted (GOHI)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 1-3 months
- Weight at study initiation: approx. 346-414 g
- Housing: individual (Macrolon Typ 3 cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal
Vehicle:
peanut oil
Concentration / amount:
1%
Day(s)/duration:
a set of intradermal injections was made on day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
100%
Day(s)/duration:
48 hours (on day 8)
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
5%
Day(s)/duration:
24 hours (on day 21)
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
The Maximization test was conducted with 10 animals in the vehicle control group and 20 animals in the test group.
Details on study design:
Pre-tests, Intradermal Induction
Injections of 0.5, 1.0, 3.0 and 5.0% test item in peanut oil produced irritation at the injection site for all concentrations. The 1.0% concentration was selected for the induction injection for the definitive test, in that it was suitable for injection, systemically well tolerated, and produced mild to moderate skin irritation.

Pre-tests. Epidermal Application
Epidermal application of 1, 5, 10, 20, 30, 50, 70% and 100% (undiluted) concentrations produced skin irritation in both sexes at 10% and higher. The undiluted (100%) test article was selected for epidermal induction as the highest concentration to produce mild to moderate irritation. The 5.0% concentration was the highest concentration to produce no irritation (highest non-irritant dose), and was therefore
selected for the epidermal challenge application.
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
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:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
other: not applicable
Hours after challenge:
24
Group:
positive control
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.

Interpretation of results:
GHS criteria not met
Executive summary:

A dermal sensitization test was conducted according OECD TG 406. Two groups of guinea pigs (10 vehicle control, 20 test) were included. On day 0, the test group animals were given a set of intradermal

injections (including 1.0% test item in peanut oil). The epidermal inductionapplication was made on day 8; the vehicle control animals were treated with the vehicle alone, and the test animals with 100% (undiluted) test item. The epidermal challenge application on day 21 consisted of a paired application of the vehicle alone and 5.0% test item in peanut oil in both groups. Skin reactions on both the vehicle and test flanks were

scored 24 and 48 hours after completion of the challenge application, according to the Draize scale.

There were no positive skin responses among either the vehicle control or test group animals on either the vehicle flank or the test flank; the sensitization rate for the test item was therefore 0%. There was no mortality, and there were no remarkable clinical observations in any of the two groups. Body weights were not affected by treatment.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study result for skin sensitisation no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.