Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 907-640-8 | 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1951
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The publication contains sufficient data to allow adequate evaluation of study results.
Data source
Reference
- Reference Type:
- publication
- Title:
- Results of the skin irritation and skin sensitization tests conducted on human subjects with DOWANOL 50B
- Author:
- Rowe, V.K., McCollister, D.D., Spencer, H.C. et al.
- Year:
- 1 951
- Bibliographic source:
- AMA Arch Ind Hyg Occup Med 9: 509-525.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Type of study:
- other: Human volunteer study
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not applicable
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Unspecified
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Unspecified
- No. of animals per dose:
- 200 men and women volunteers participated
- Details on study design:
- Undiluted Dowanol 50B was applied to the backs of 200 human subjects (100 males and 100 females) and allowed to remain in direct contact with the skin for a period of five days. At the end of this period, the patches were removed and any irritation noted. Three weeks later, Dowanol 50B was applied again to the backs of the same subjects and allowed to remain in contact with the skin for a period of 48 hours.
In another additional test, Dowanol 50B was tested by a repeated insult method on 50 unselected human subjects (25 males and 25 females). Dowanol 50B was applied to the backs of the subjects for 4-8 hours every other day until 10 applications were made. After a lapse of 3 weeks, the material was reapplied for a period of 24-48 hours. - Challenge controls:
- Not performed
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- no evidence of irritation or sensitisation
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no evidence of irritation or sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In conclusion DOWANOL 50B (DPM) was found to be neither a primary skin irritant nor a skin sensitizer. None of the human subjects exhibited any evidence of irritation during the study.
- Executive summary:
Undiluted DPM was applied to the backs of 200 unselected human subjects, 100 males and 100 females, and allowed to remain in direct contact with the skin for 5 days. Three weeks later, DPM was again applied to the backs of the same subjects and allowed to remain in contact with the skin for a period of 48 hours.
DPM was tested by a repeated insult method on 50 unselected human subjects, 25 males and 25 females. The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.In conclusion DPM was classified as neither a primary skin irritant nor a skin sensitizer as none of the human subjects exhibited any evidence of irritation during the study.
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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