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EC number: 604-045-2 | CAS number: 137862-53-4
Skin sensitisation
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:
- 1 995
- 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
- 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
Constituent 1
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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