Registration Dossier
Registration Dossier
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EC number: 617-590-6 | CAS number: 846023-24-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 15 July - 04 August 2009
- Reliability:
- 1 (reliable without restriction)
Data source
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-cyano-N-(2,4-dichloro-5-methoxyphenyl)acetamide
- EC Number:
- 617-590-6
- Cas Number:
- 846023-24-3
- Molecular formula:
- C10H8Cl2N2O2
- IUPAC Name:
- 2-cyano-N-(2,4-dichloro-5-methoxyphenyl)acetamide
- Details on test material:
- Molecular formula C10H8Cl2N2O2
Molecular weight 259.09
CAS Number 846023-24-3
Description: Ivory flakes (determined at NOTOX)
Batch 18238505
Purity 97.3%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 20 females (nulliparous and non-pregnant), five females per group.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI values calculated for the substance concentrations 10, 25 and 50% were 1.3, 5.1 and 3.0 respectively. These results indicate that the test substance could elicit an SI ≥ 3. The data showed a dose response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 16.7% was calculated. The response of the 50% group did not follow the expected doseresponse relationship which more often seen in these kind of studies. The response might be less due to differences in skin penetration (less vehicle present), viscosity or due to underlying systemic toxicity.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The median DPM values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 406, 1574 and 939 respectively. The median DPM value for the vehicle control group was 308.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information (Category 1)
- Conclusions:
- Based on these results:
- according to the recommendations made in the test guidelines, WAY-186478 would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007), WAY-186478 should be classified as skin sensitizer (Category 1).
- according to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, WAY-186478 should be classified as skin sensitizer (Category 1)
and labeled as H317: May cause an allergic skin reaction.
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