Registration Dossier
Registration Dossier
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EC number: 610-200-5 | CAS number: 446292-07-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Oct 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
- EC Number:
- 610-200-5
- Cas Number:
- 446292-07-5
- Molecular formula:
- C21 H21 N3 O5
- IUPAC Name:
- 2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione
- Details on test material:
- Hydroxyaminophthalimid, white powder, Batch BXR3528, content 98.2%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0 (vehicle control), 3, 10 and 30%
- No. of animals per dose:
- 6 females
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes.
Any other information on results incl. tables
The "positive level" of ear swelling (i.e. increase of about 10% of the control values) has not been reached or exceeded in any dose group. No substance specific effects were determined for ear weights either.
The body weights of the animals were not affected by any treatment.
Tabular summary of the LLNA/IMDS results:
| Direct LLNA | Ear swelling (in 0.01 mm) | Ear weight (in mg per 8 mm diameter punch) | |||||
| Dose (%) | Weight index (mean +/- SD in %) | Cell count index (mean +/- SD in %) | day 1 (mean +/- SD in %) | day 4 (mean +/- SD in %) | Index day 4 | day 4 (mean +/- SD in %) | Index day 4 |
| 0 (DMSO) | 1.00 +/- 16.40 | 1.00 +/- 18.98 | 18.50 +/- 4.89 | 20.33 +/- 9.69 | 1.00 | 12.55 +/- 5.84 | 1.00 |
| 2 | 0.97 +/- 27.08 | 0.87 +/- 36.34 | 18.08 +/- 4.39 | 19.75 +/- 5.76 | 0.97 | 12.38 +/- 5.05 | 0.99 |
| 10 | 1.11 +/- 17.36 | 1.03 +/- 17.99 | 17.58 +/- 3.80 | 19.08 +/- 6.87 | 0.94 | 11.99 +/- 8.04 | 0.96 |
| 50 | 1.01 +/- 17.37 | 0.86 +/- 26.05 | 17.67 +/- 4.41 | 20.92 +/- 7.20 | 1.03 | 12.92 +/- 7.09 | 1.03 |
Applicant's summary and conclusion
- Executive summary:
To determine the skin-sensitizing properties of Hydroxyaminophthalimid the LLNA was performed on female NMRI mice according to OECD guideline 429, 406 and EPA OPPTS 870.2600. The study was conducted with the following test substance concentrations: 3, 10 and 30%
The results showed that the test item has no sensitising potential in mice after dermal application of up to and including 30% concentration. No indication for a non-specific (irritating) activation was detected, too.
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