Registration Dossier
Registration Dossier
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EC number: 240-185-7 | CAS number: 16044-24-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological studies on malachite green: A triphenylmethane dye.
- Author:
- Clemmensen S., Jensen C., Jensen N., Meyer O., Olsen P., Wurtzen G.
- Year:
- 1 984
- Bibliographic source:
- Arch Toxico l1984) 56: 43-45
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Malachite Green Oxalate was tested on guinea pigs by intradermal injection to assess sensitization, according to the Maximization method of Magnusson and Kligman (1970).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
Test material
- Reference substance name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- EC Number:
- 241-922-5
- EC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Cas Number:
- 18015-76-4
- Molecular formula:
- C25H26N2O4
- IUPAC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Green 4
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ssc:AL
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Statens Serum Institut, Copenhagen, Denmark
- Weight at study initiation: 300 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 50 µL 0.2% aquous malachite green per injection
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 400 µl 20 % aqueous suspension
- Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 µL in Finn-chambers (Epitest Oy, Finland) of either 0.05%, 0.1%, or 1%
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 in test and 5 in control group
- Details on study design:
- MAIN STUDY
It was not necessary to use laurylsulphate pretreatment, as the injections left the area slightly irritated even after 7 days.
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Concentrations:
first induction: 50 µl 0.2 % aqueous Malachite Green per injection
second induction: 400 µl 20 % aqueous suspension was applied under occlusion.
- Exposure period: 48 h
B. CHALLENGE EXPOSURE
- No. of exposures: the challenge was made with 25 µl in Finn-chambers (Epitest Oy, Finland) of either 0.05 %, 0.1 %, or 1 % aqueous Malachite Green. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05%, 0.1%, or 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05%, 0.1%, or 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05%, 0.1%, or 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05%, 0.1%, or 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin sensitising effects were observed in the Guinea Pig Maximisation Test
- Executive summary:
The maximization method of Magnusson and Kligman (1970) was used with minor modifications in order to assess the dye skin sensitisation potential. The volume and concert tration used for the first induction was 50 µl 0.2 % aquous Malachite Green per injection. During the second (topical) induction 400 µl 20 % aqueous suspension was applied under occlusion (Leukoflex, Beiersdorf AG, FRG) for 48 h. It was not necessary to use laurylsulphate pretreatment, as the injections left the area slightly irritated even after 7 days. The challenge was made with 25 µl in Finn-chambers (Epitest Oy, Finland) of either 0.05 %, 0.1 %, or 1 % aqueous Malachite Green.
Within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.
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