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EC number: 209-566-5 | CAS number: 585-86-4
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- other: Published secondary source
- Title:
- Lactitol
- Author:
- WHO/FAO
- Year:
- 1 983
- Bibliographic source:
- WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)
Materials and methods
- Principles of method if other than guideline:
- The experiment was conducted according to the guinea pig maximization test, as described by B. Magnusson and A.M. Kligman, in "Allergic contact dermatitis in the guinea pig", Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig data available prior to 2009.
Test material
- Reference substance name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- EC Number:
- 209-566-5
- EC Name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- Cas Number:
- 585-86-4
- Molecular formula:
- C12H24O11
- IUPAC Name:
- 4-O-beta-D-galactopyranosyl-D-glucitol
Constituent 1
- Specific details on test material used for the study:
- Test material:
- Sample of the material was taken from a batch of 950 kg which was received and stored at ambient temperature.
- Test material was a white crystalline powder containing 9.67% water and purity of more than 98% on the dry matter.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF bred albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Weight at study initiation: 261 to 342 g
- Housing: individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet (e.g. ad libitum): fed pelleted stock diet ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period: 1 day
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1⁰C
- Humidity (%): ≥40 %
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Freund's complete adjuvant (FCA), 40% (w/v) dilution of the test substance in water, and 40% (w/v) dilution of the test substance in a mixture of FCA and water (1:1)
- Day(s)/duration:
- Three injections made simultaneously
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 40% (w/v) dilution of test substance in water
- Day(s)/duration:
- 1 week after intradermal injections for 48 hours
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 20% (w/v) dilution of the test substance in water
- Day(s)/duration:
- 2 weeks after topical induction for 24 hours
- No. of animals per dose:
- 10/test substance; 5/negative control
- Details on study design:
- Preliminary Test:
For preliminary observations, guinea pigs were used that had already been served as controls in other sensitization tests. The intradermal and topical irritancy of a range of dilutions of the test substance were examined. The maximum concentration suitable for intradermal injection was found to be 40 % w/v in water, and for topical application 40% w/v in water.
Main study:
Induction Procedure-
Induction was in a two-stage operation consisting of firstly three pairs of injections made simultaneously and, secondly, one week later, a closed patch exposure performed over the injection sites. For this purpose, an area of dorsal skin 4 x 6 cm on the shoulder region was clipped free of hair with electric clippers.
Intradermal Injections-
Three pairs of intradermal injections were made in the clipped area of the animals. Preparations were made and injected into the skin of the test animals with skin readings made 24 hours after treatment.
Topical application-
One week after the injections were made, the same area of the skin was clipped again and closely shaved with an electric clipper and topically treated with the test substance. A 2 x 4 cm patch of filter paper was soaked in a 40 % (w/v) dilution of the test substance in water. The patch was placed on the skin and covered with a piece of PVC foil. This in turn was firmly secured by an elastic adhesive bandage wound round the torso of the animal. The end of the bandage was covered by self sticking tape. The dressing was left in place for 48 hours. The controls were treated in the same way, except that the patch was soaked in water. Skin readings were made after removal of the patches.
Challenge Procedure-
Both test and control animals were challenged two weeks after the topical induction as follows:
An area 5 x 5 cm on the left flank of the animal was clipped free of hair and closely shaved. Subsequently, a 2 x 2 cm patch of filter paper was soaked in a 20 % (w/v) dilution of the test substance in water. The patch was placed on the shaved area under a piece of PVC foil and secured. The dressing was kept in place for 24 hours. Skin readings were made at 0, 24 and 72 hours after removal of the patches. The reactions to the challenge were judged according to a method described by J.H. Draize, G. Woodard and H.O. Calvery (J. Pharmacol. exp. Therap. 82 (1944) 377-390). The sensitization was classified according to Magnusson and Kligman (1970). - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
All animals remained in good health during the experimental period. With Freund's Complete Adjuvant, there was slight erythema and slight edema in the test animals. With 40% dilution of the test substance in water and with water alone; slight erythema, in one test animal. With 40% dilution of the test substance in a mixture of FCA and water (1:1) and with the mixture alone: erythema, edema and abscesses. The topical application made with water in the control animals did not induce either erythema or edema. With a 40% dilution of the test substance in water,3 out of 10 test animals showed slight erythema. The challenge test with 20% of the test substance in water induced a slight allergic response reaction in 2 out of the 10 test animals. This reaction was observed only after the removal of the dressing. Twenty-four hours later none of the test animals showed any reaction. The controls did not show a positive reaction either directly after the removal of the dressing or 24 hours thereafter. On the basis of the results obtained, it appears that the test substance Lactitol exhibited slight sensitization properties according to the classification of Magnusson and Kligman.
Applicant's summary and conclusion
- Conclusions:
- Slight sensitization properties (Challenge with 20% induced a slight allergic response reaction in 2/10 test animals after removal of dressing. 0/10 animals showed reaction 24-hours later).
- Executive summary:
A maximization test was carried out on 15 young male guinea-pigs. The maximum concentration of lactitol, suitable for intradermal injection and topical application, was found to be 40% w/v in water; these concentrations were utilized. From the reaction to the challenge dose, it was concluded that the test substance exhibited slight sensitization properties (challenge with 20% induced a slight allergic response reaction in 2/10 test animals after removal of dressing. 0/10 animals showed reaction 24-hours later).
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