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Diss Factsheets
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EC number: 200-372-6 | CAS number: 58-27-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitizing capacity of naturally occurring quinones - Experimental studies in guinea pigs. I. Naphthoquinones and related compounds
- Author:
- Schulz KH, Garbe I, Hausen BM and MH Simatupang
- Year:
- 1 977
- Bibliographic source:
- Arch. Derm. Res. 258, 41-52
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was initiated with two subcutaneous administrations of 0.1% Freund’s complete adjuvant (FCA) in physiological NaCl on hind legs at intervals of 4 days. The animals were challenged with the test substance by an epicutaneous application of 3 different molar concentrations of test substance to a 2 cm2 area on the flank. The intensity of the reactions was evaluated 24 and 48 hours after the challenge for erythema, infiltration and exsudation on the scale of 0-3 ranging from no reaction to intense erythema, infiltration and exsudation.
- GLP compliance:
- no
- Type of study:
- other: skin sensitization in vivo
- Justification for non-LLNA method:
- Study conducted prior to development of LLNA method
Test material
- Reference substance name:
- Menadione
- EC Number:
- 200-372-6
- EC Name:
- Menadione
- Cas Number:
- 58-27-5
- Molecular formula:
- C11H8O2
- IUPAC Name:
- 2-methyl-1,4-dihydronaphthalene-1,4-dione
Constituent 1
- Specific details on test material used for the study:
- MW: 172
origin: trade product (Merck)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- The animal weight was 400-500g. The animals were fed with «Altrumin» and water ad libitum.
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: subcutaneous
- Vehicle:
- other: Freund's complete adjuvant mixed 1+1 with physiol. NaCl solution
- Concentration / amount:
- 0.1 mL of 0.005 molar emulsion per 500 g bw
- Day(s)/duration:
- 2 times at intervals of 4 days
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- 1/100; 1/500; 1/1000 molar
- Day(s)/duration:
- Evaluation 24 and 48 hrs after challenge
- No. of animals per dose:
- 12
- Details on study design:
- Reactions on skin were evaluated and a mean response for each group was calculated by summing the numerical readings and dividing the sum by the number of animals in the group.
- Challenge controls:
- The threshold level of primary irritation of the substance was determined before sensitization experiments by a single application of three different concentrations to the skin of non-sensitized control animals (resp. guinea pigs treated with Freund's adjuvant alone).
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: mean response
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1/100 molar
- No. with + reactions:
- 5
- Total no. in group:
- 12
- Clinical observations:
- distinct confluent erythema and infiltration, distinct erythema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Mean response 0.6
- Reading:
- other: mean response
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1/500 molar
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- slight spotted erythema
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Mean response 0.04
- Reading:
- other: mean response
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1/1000 molar
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no reaction
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The results of the sensitization assay are presented in the table below. The reactions were scaled as follows:
(+) slight spotted erythema
+ distinct erythema
++ distinct confluent erythema and infiltration
+++ intense erythema, infiltration and exsudation
No reaction
|
|
Number of animals with a reaction |
|
||||
Animals / group |
Dose group (molar) |
+++ (score 3) |
++ (score 2) |
+ (score 1) |
(+) (score 0.5) |
No reaction (Score 0) |
Mean response |
12 |
1/100 |
- |
2 |
3 |
- |
7 |
0.6 |
12 |
1/500 |
- |
- |
- |
1 |
11 |
0.04 |
12 |
1/1000 |
- |
- |
- |
- |
12 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Menadione showed a weak sensitizing effect in the guinea pigs.
- Executive summary:
Menadione was tested in guinea pigs for skin sensitization. The animals were treated subcutaneously with FCA, followed by an epicutaneous administration of the test substance in three different concentrations. Skin reactions were observed 24 and 48 hours after the challenge. Menadione showed a weak sensitizing effect in the guinea pigs.
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