Registration Dossier
Registration Dossier
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EC number: 700-129-9 | CAS number: 2004-62-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The testing was conducted between 29 June 2009 to 28 July 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP and test guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3,3'-(hexane-1,6-diyldiimino)dipropanenitrile
- EC Number:
- 700-129-9
- Cas Number:
- 2004-62-8
- Molecular formula:
- C12H22N4
- IUPAC Name:
- 3,3'-(hexane-1,6-diyldiimino)dipropanenitrile
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (e.g. ad libitum): Free access to mains tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 oC
- Humidity (%): 30 to 70%
- Air changes (per hr): approx. 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00) and 12 hours darkness.
IN-LIFE DATES: From: 29.06.2009 To: 28.07.2009
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25%, 10% and 5% in dimethyl formamide.
- No. of animals per dose:
- Four animals per dose.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 27.44
- Test group / Remarks:
- 4
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (% v/v) in dimethyl formamide: 5 Result: Positive
- Parameter:
- SI
- Value:
- 41.49
- Test group / Remarks:
- 4
- Remarks on result:
- other:
- Remarks:
- Concentration (% v/v) in dimethyl formamide: 10 Result: Positive
- Parameter:
- SI
- Value:
- 71.34
- Test group / Remarks:
- 4
- Remarks on result:
- other:
- Remarks:
- Concentration (% v/v) in dimethyl formamide: 25 Result: Positive
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
The test material was considered to be a sensitiser under the conditions of the test.
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