Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 426-290-2 | CAS number: 74149-72-7
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
