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Diss Factsheets
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EC number: 944-549-2 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Buehler method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.09.04 - 2000.10.20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- In vivo data for MI3 skin sensitization to the guinea-pig was allready avalible prior initiating this registration dossier.
Test material
- Test material form:
- other: Cream powder (84% w/w)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MI3, CHD NO. 0179/00-0665 Lot 2, Batch number: C202493
- Expiration date of the lot/batch: December 2000
- Purity 98.67 % (295 mg active sub/g crude sub)
- Purity test date: 2000.07.13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: - 20 degrees celsius, in the dark.
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: up to 90 % w/v in water.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Fresh prepared smooth brown paste (90 %w/v) using water on the day of exposure
- Final preparation of a solid: Freshly prepared smooth brown paste (90 %w/v) using water on the day of exposure
FORM AS APPLIED IN THE TEST (if different from that of starting material) freshly prepared paste (*90 %w/v) using water as vehicle.
:
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dunkin/Hartley, albino
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Microbiological status of animals, when known: NA
- Age at study initiation: 5 - 8 weeks old.
- Weight at study initiation: 351 - 427g
- Housing: groups of five animals in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum, vitamin C enriched guinea pig diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
- Indication of any skin lesions: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 degree celsius
- Humidity (%): 30 - 70 %
- Air changes (per hr): NA
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12hrs light
- IN-LIFE DATES: From: To: 2000.09.04 - 2000.10.20
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- MI3, 90% w/v in sterile water
- Day(s)/duration:
- on Days 1, 8 and 15.
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- MI3, 90% w/v in sterile water
- Day(s)/duration:
- Challange two weeks after the final induction and examinations after 24 and 48 hours.
- Adequacy of challenge:
- other: the maximum practical concentration that could be prepared and dosed topically and not given rise to irritating effects.
- No. of animals per dose:
- Control animals (n=10).
Test animals (n=20).
Preliminary investigations (n=4). - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Day 1, Day 8 and Day 15.
- Test groups: MI3 exposure, 20 animals
- Control group: Vehicle (sterile water) exposure, 10 animals
- Site: Left shoulder region
- Frequency of applications: 3 times
- Duration: 6 hours
- Concentrations: 90% w/v in sterile water
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after final induction
- Exposure period: 6 hours
- Test groups: MI3 exposure, 20 animals
- Control group: Exposured as test group, 10 animals
- Site: The right flank
- Concentrations: 90% w/v in sterile water
- Evaluation (hr after challenge): 6 hours
OTHER: - Challenge controls:
- yes as test animals challanged with MI3 90% v/v
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde (HCA) as 50% v/v in Alembicol D
Results and discussion
- Positive control results:
- Induction:
Slight to well-defined dermal reactions were observed for all test animals during the induction period and no dermal reactions were observed for the control animals.
Challenge:
The dermal reaction seen in all the ten test animals were more marked than those for controls, therefore the reactions seen in all of the test animals were considered to represent evidence of skin sensitization.
Conclusion:
In this study HCA produced evidence of skin sensitization in all of the ten animals, thus confirming the sensitivity and reliability of experimental technique to detect skin sensitization potential.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- MI3, 90% w/v in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- MI3, 90% w/v in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the skin sensitization potential of MI3 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test”. The MI3 dose level was chosen to be 90% v/v from a preliminary study, and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications with either MI3 (90% v/v) or water, respectively, and a challenge test two weeks after the final induction. There was no indicative of systemic toxicity or ill health for any of the guinea-pigs. In this study MI3 did not produce evidence of skin sensitization in any of the twenty test animals.
- Executive summary:
The Study was conducted to determine the skin sensitization potential of MI3 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test” the commission directive 96/54/EC, Method B6, and the US EPA Health effects test Guidelines OPPTS 870.2600. The MI3 dose level was chosen to be 90% v/v from a preliminary study and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications on the shoulder region at Day 1, 8 or 15 with either MI3 (90% v/v) or water, respectively. All animals were challenged test two weeks after the final induction and examined after 24 or 48 hours. There was no indicative of bodyweight loss, systemic toxicity or ill health for any of the guinea-pigs. All animals exposed to HCA showed positive evidence of skin sensitization after 48 hours. In the present study, MI3 did not produce evidence of skin sensitization in any of the twenty test animals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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