Registration Dossier
Registration Dossier
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EC number: 627-071-6 | CAS number: 1233873-37-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline under GLP. Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 174333-80-3
- EC Number:
- 605-717-8
- Cas Number:
- 174333-80-3
- IUPAC Name:
- 174333-80-3
- Details on test material:
- - Name of test material (as cited in study report): Lix 860N-NEAT (C-9-Aldoxime)
- Physical state: viscous, amber-cloured liquid
- Lot/batch No.: 070596
- Expiration date of the lot/batch: 09/1997
- Storage condition of test material: room temperture, dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4h
- Observation period:
- 21 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72h
- Score:
- ca. 1.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
- Executive summary:
The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.
The amount of 0.5 ml of the substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.
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