Registration Dossier
Registration Dossier
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EC number: 263-418-4 | CAS number: 62121-76-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo test (maximisation test) was available already.
Test material
- Reference substance name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- EC Number:
- 263-417-9
- EC Name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- Cas Number:
- 62121-75-9
- Molecular formula:
- C20H22N4O11S3.xNa C20H(22-x)N4NaxO11S3; x<=2
- IUPAC Name:
- sodium 4-[4-(2-{2-methoxy-5-methyl-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, breeding colony, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: mean = 334 g (n = 30)
- Housing: in fully air-conditioned rooms in Makrolon cages on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 d
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12:12
Identification with cage numbering and fur-marking (KMnO4)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic saline
- Concentration / amount:
- 25% in isotonic saline
- Day(s)/duration:
- day 8, day 22, day 29; duration: 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Freund´s Adjuvant, isotonic saline
- Concentration / amount:
- 5% in vehicle 1 and 5% in vehicle 2
- Day(s)/duration:
- day 1; duration: 7 d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Details on study design:
- RANGE FINDING TESTS: determination of primary non-irritant concentration in dermal-occlusive test, determination of tolerance of intradermal injections
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 32 d
- Test groups: 3
- Control group: 1
- Site: 3 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No clinical signs for intoxication or increase in body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the 20 animals in the treatment group showed a positive response after the repeated challenge procedure. The test substance did not show evidence for sensitizing properties.
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