Registration Dossier
Registration Dossier
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EC number: 277-539-5 | CAS number: 73570-52-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Oct - 28 Dec 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no information on positive control
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test conducted prior to development of the LLNA test method (1978).
Test material
- Reference substance name:
- 3,7-bis(diethylamino)phenoxazin-5-ium acetate
- EC Number:
- 279-349-8
- EC Name:
- 3,7-bis(diethylamino)phenoxazin-5-ium acetate
- Cas Number:
- 79916-07-7
- Molecular formula:
- C20H26N3O.C2H3O2
- IUPAC Name:
- 3,7-bis(diethylamino)phenoxazin-5-ium acetate
- Test material form:
- solid
- Details on test material:
- Purity: 28.8%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: own breed
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 270 - 360 g
- Housing: Macrolon type III cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 10 d
- Indication of any skin lesions: only healthy animals used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 50 - 60 % rh
- Photoperiod (hrs dark / hrs light): 14 / 10 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%, 3 injections every 2nd day, 0.1 mL
- Day(s)/duration:
- Day 1 to 7 / 7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%, vehicle : Bacto adjuvant 50:50, 7 injections every 2nd day
- Day(s)/duration:
- Day 8 to 22 / 14 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% / 0.1 mL
- Day(s)/duration:
- Day 36 / single injection
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 46 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (10 males, 10 females)
- Challenge controls:
- Physiological saline
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1% test material intradermal
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% test material epicuteneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%, intradermal injection
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- no erythema
- Remarks on result:
- other: based on skin-fold thickness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%, epicutaneous application
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- based on skin-fold thickness
Any other information on results incl. tables
Intradermal injection of the vehicle alone failed to induce sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not found to be skin sensitising in guinea pigs (GPMT).
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