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EC number: 426-290-2 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 March 1997 to 12 May 1997
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Compliant to GLP; adequate coherence between data, comments and conclusions. There is a doubt on quality of induction and therefore if exposure was sufficient: indeed, there was no indication if irritation was noted during induction phase (the chosen concentration of 25% was well-tolerated according to a screening test, but no higher concentration was tested in the preliminary test (according to the study report, 25% is the recommended concentration for topical application in OCDE 406, that is not true). Moreover, the choice of the concentration of 25% for topical application of the challenge phase was not explained in the study report (was it the maximal practicable non irritant concentration ?).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- There was no indication on how the challenge concentration was chosen: this concentration should be the maximal practicable non irritant concentration; skin reactions after induction phase were not reported (no indication if irritation was reached).
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 426-290-2
- EC Name:
- -
- Cas Number:
- 74149-72-7
- Molecular formula:
- C20H20N2O7
- IUPAC Name:
- methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): UD-CG 115 Nitrobenzamide (Gamma-NAP)
- Substance type: monoconstituent
- Analytical purity: 99.8%
- Purity test date: 10 February 1997
- Lot/batch No.: 1/94
- Stability under test conditions: guaranteed until February 1999.
- Stability 25% Gamma NAP solution in ethanol: guaranteed at least during 48 hours
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Interfauna Company
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation: 563 - 757 g
- Housing: housed individually in Noryl cages, type IV
- Diet (e.g. ad libitum): dry food in pellet form (Nafag)
- Water (e.g. ad libitum): minicipal drinking water
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9/15 hours
IN-LIFE DATES: From: 17 March 1997 To: 10 April 1997.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction:
- intradermal injections: 1% in ethanol
- epicutaneous applications: 25% in ethanol
Challenge: 25% in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction:
- intradermal injections: 1% in ethanol
- epicutaneous applications: 25% in ethanol
Challenge: 25% in ethanol
- No. of animals per dose:
- 20 treated animals, 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
In a preliminary test was found that a 2.5% solution in absolute ethanol showed skin irritations (reddening and necrosis 48 hours p.a.) after intradermal injections. A 1% solution showed good local tolerance. No signs of systemic toxicity were observed.
The 25% solution in absolute ethanol showed very good local tolerance on 48 hour occlusive application to intact skin in a preliminary study, and no signs of systemic toxicity were observed.
Therefore the concentrations of 1% for the intradermal injections and 25% for the occlusive application were chosen.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: topical induction lasted 48 hours
- Test groups: 3 pairs of intradermal injections (0.1 mL of 1% Gamma NAP solution in absolute ethanol, 0.1 mL of mixture 1:1 FCA + 0.0% NaCl solution, 0.1 mL of mixture 1:1 FCA + 2% Gamma NAP solution in absolute ethanol)
- Control group: 3 pairs of intradermal injections (0.1 mL of absolute ethanol, 0.1 mL of mixture 1:1 FCA + 0.9% NaCl solution, 0.1 mL of mixture 1:1 FCA + absolute ethanol)
- Site: back (dorsal skin)
- Duration: from Day 1 (intradermal injection) to Day 10 (epicutaneous application on Day 8
- Concentrations: 1% Gamma NAP solution
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Site: left flank (test item) and right flank (absolute ethanol)
- Concentrations: 25% solution of Gamma NAP in absolute ethanol
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is not a skin sensitizer under the conditions of the study.
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