Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-285-3 | CAS number: 5343-92-0
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- ; original guideline 406, adopted in 1981
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
Test material
- Reference substance name:
- Pentane-1,2-diol
- EC Number:
- 226-285-3
- EC Name:
- Pentane-1,2-diol
- Cas Number:
- 5343-92-0
- Molecular formula:
- C5H12O2
- IUPAC Name:
- pentane-1,2-diol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 221 g - 451 g
- Housing: individually in Macrolon cages type 3
- Diet:. ad libitum
- Water: ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 50 % +/- 10 %
- Photoperiod: 14 h light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline;
during the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
Challenge intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline
Challenge epicutaneous:
10 % of test item in vaseline
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline;
during the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
Challenge intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline
Challenge epicutaneous:
10 % of test item in vaseline
- No. of animals per dose:
- 10 male and 10 female animals
- Details on study design:
- During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1% solution of test item in physiological saline. One control group was treated with the vehicle alone ("negative control" ) . On the first day, injections of 0.1 ml were administered into the shaved skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1).
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of test item in physiological saline was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
The two largest perpendicular diameters (in mm) and the increase in the skin-fold thickness (in mm) were measured and by multiplication of these values a "reaction volume" was obtained (in µl) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control croup (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control") .
Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (10% test item in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 hours after removing of the bandages according the Draize scoring scale. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Reading after intradermal challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml of 0.1 % solution of test item in physiological saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: Reading after intradermal challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml of 0.1 % solution of test item in physiological saline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: reading after epicutaneous challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % solution of test item in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: reading after epicutaneous challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % solution of test item in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Intradermal injections of the vehicle alone failed to induce sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions employed the test item was found to be devoid of skin sensitizing potency in albino guinea pigs.
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.