Registration Dossier
Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, no data on postive controls, report does not contain all details normally required.
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Information on postive control treatments not included.
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Details in Study plan No. 25910 TSS, not available in report
IN-LIFE DATES: From: 2003-05-21 To:2003-05-26
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (1:1)
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 4
- Details on study design:
- Results of a range-finding test were not reported.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control: 1 5% : 1.69 10%: 1.18 25%: 1.08
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see figure
Any other information on results incl. tables
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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