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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.09.1995 - 12.10.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no data on positive control group
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
no data on positive control group
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
N-Pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine
EC Number:
604-045-2
Cas Number:
137862-53-4
Molecular formula:
C24 H29 N5 O3
IUPAC Name:
N-Pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White (Tif:DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Stein, Switzerland
- Weight at study initiation: 338 - 430 g
- Housing: Animals were housed individually in Macrolon cages (Type 3).
- Diet: standard guinea pig pellets (NAFAG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 18 Sep 1995
To: 12 Oct 1995

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: peanut oil, vaseline
Concentration / amount:
1% test substance in peanut oil (intradermal) and 50% test substance in vaseline (epicutaneous)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: peanut oil, vaseline
Concentration / amount:
1% test substance in peanut oil (intradermal) and 50% test substance in vaseline (epicutaneous)
No. of animals per dose:
test group: 10 males and 10 females
control group: 5 males and 5 females
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single intradermal injection on Day 0 and 48 h epicutaneous treatment on Day 8
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: 1% of test substance in peanut oil
Injection 3: 1% of test substance in a 1:1 mixture (v/v) FCA/physiological saline

Epicutaneous: 50% of the test substance in vaseline

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: peanut oil
Injection 3: a 1:1 mixture (v/v) FCA/physiological saline

Epicutaneous: vaseline

- Site: shoulder region (intradermal and epicutaneous, respectively)
- Frequency of applications: on Days 0 and 8
- Concentrations: intradermal 1%, epicutaneous 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Site: one flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 h
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% test substance in vaseline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% test substance in vaseline
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% test substance in vaseline. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% test substance in vaseline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% test substance in vaseline
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% test substance in vaseline. No with. + reactions: 2.0. Total no. in groups: 20.0.

Any other information on results incl. tables

After removal of the occlusive dressing on Day 10 after epidermal induction, irritation at the application site was seen in all 20 guinea pigs of the test group.

Epidermal challenge of 10 male and 10 female guinea pigs (test group) resulted in positive responses in 1 female after 24 h and in 2 females after 48 h, corresponding to a sensitisation rate of 10%. No skin reactions were recorded for control animals.

Body weights were not affected by treatment with the test substance.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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