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Registration Dossier
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EC number: 222-392-4 | CAS number: 3458-28-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.1200
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan Test Guidelines for Agricultural Chemicals 12-Nousan-8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-mannose
- EC Number:
- 222-392-4
- EC Name:
- D-mannose
- Cas Number:
- 3458-28-4
- Molecular formula:
- C6H12O6
- IUPAC Name:
- D-mannose
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity: >99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: Mean rat weight: Male - 296.1 g; Female - 219.1 g
- Fasting period before study: not reported
- Housing: housed individually in solid-bottom caging with bedding and appropriate species-specific enrichment
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6-day quarantine period
ENVIRONMENTAL CONDITIONS
- Temperature: 20-26ºC
- Humidity: 30-70%
- Photoperiod: approximate 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 5000 mg/kg body weight
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: The paste was spread evenly, directly on the skin, covering an area of approximately 37 square centimetres.
- % coverage: Thirty-seven square centimeters is equal to approximately 10 percent of the total body surface area of rats in the 200 - 300 g body weight range.
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Approximately 24 hours after treatment,
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance was measured for each animal on the day of treatment at a dose of 5000 mg/kg of body weight. The amount of test substance designated for each animal was calculated based on body weights collected prior to treatment.
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): The aliquot of test substance designated for an animal was moistened with approximately 1 mL of deionized water to form a thick paste.
- Duration of observation period following administration: 15 days
- Frequency of observations: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, and abnormal behaviour. The rats were weighed on test days 1, 8, and 15, and were observed daily for clinical signs of toxicity and dermal irritation (weekends and holidays excluded for dermal irritation)
- Other examinations performed: All rats were euthanized at the end of the 15-day test period and examined to detect grossly observable evidence of organ or tissue damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- other: 24-hours to 14 days
- Score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other:
- Remarks:
- On test day 1 and 2, erythema was observed in 3/5 male animals, with a score of 1. All erythema was resolved by test day 3.
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- other: 24 hours to 14 days
- Remarks on result:
- other: no oedema observed
- Irritant / corrosive response data:
- At the beginning of the observation period (approximately 24 hours after exposure), on test day 2, erythema was observed in 3/5 male animals, with a score of 1. All erythema was resolved by test day 3. There were no instances of edema observed.
- Other effects:
- Refer to acute dermal toxicity study DI.K1.Derm.R.D-21373-673.KD in IULICD section 7.2.3 (Acute toxicity: dermal) for additonal information.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At the beginning of the observation period (approximately 24 hours after exposure), on test day 2, erythema was observed in 3/5 male animals, with a score of 1. All erythema was resolved by test day 3. There were no instances of edema observed. These findings do not meet the criteria for classifying for skin irritation.
- Executive summary:
A single dose of the test item was applied to the shaved, intact skin of 5 male and 5 female rats at a dose level of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage at the end of the 15-day test period.
There were no incidents of mortality and no overall body weight losses. One male exhibited scabbing on the right shoulder, between test days 12-15. No other clinical abnormalities were observed. At the beginning of the observation period (approximately 24 hours after exposure), on test day 2, erythema was observed in 3/5 male animals, with a score of 1. All erythema was resolved by test day 3. There were no instances of edema observed. No gross lesions were present in the rats at necropsy.
Under the conditions of this study, the dermal LD50 for the test item was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.
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