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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 920-901-0 | 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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Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988/09/26 - 1988/11/11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with sound scientific principles and performed with good laboratory standards.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988/09/26 - 1988/11/11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with sound scientific principles and performed with good laboratory standards.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Results of examinations:
- Phase II: Determination of Phototoxicity and Primary Irritancy
-Results: MRD-88-296 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant.
Skin patches exposed to MRD-88-296 displayed no signs of skin irritation. The dermal irritation scores were 0 for all subjects (26 people), on all days of exposure to MRD-88-296. A faint erythema (score of 1) was observed in skin patches exposed to MRD-88-296 and UV light for most subjects, however subjects exposed to only UV light displayed a similar erythema (score of 1).
Phase III - Determination of Photocontact and Contact Allergenic Capabilities
-Results: MRD-88-296 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. No erythema was observed during the rechallenge phase of exposure (score of 0 for all subjects). - Conclusions:
- Based on these data and results, MRD-88-296 would not be classified as a dermal irritant or as a dermal sensitizer.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10-C12, isoalkanes,, <2% aromatics based on analogue read across.
This study was conducted to determine the potential of MRD-88-296 to cause dermal irritation and sensitization in humans with or without UV irradiation. Twenty-eight humans were exposed to MRD-88-296. Dermal examinations occurred after exposures (day 1 and day 2) and then at 24h, 48h, and 72h post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" or slight erythema. MRD-88-296 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-296 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. Based on these data and results, MRD-88-296 would not be classified as a dermal irritant or as a dermal sensitizer.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- human skin patch test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C10 – C12, isoalkanes, < 2% aromatics
- IUPAC Name:
- Hydrocarbons, C10 – C12, isoalkanes, < 2% aromatics
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- 30 participants; 29 participants completed the study.
- Clinical history:
- A past/present medical history and a brief physical was performed for each individual. Candidates were excluded for any one of the following reasons: systemic illness which might have contra-indicated participation, skin disease, medication which might augment/suppress effects of test material, participation in another sensitization study within the past 10 weeks.
- Controls:
- Controls were performed
- Route of administration:
- dermal
- Details on study design:
- Phase I: Determination of MED (Minimum Erythemogenic Dose - UVB light produced Erythemogenic Effects)
-Design: 5 sites on the back and 5 sites on the arm were exposed to UVB light for either 10,20,30,40, or 50 seconds at 10cm from the exposure site. Sites were examined at 18 and 24 hours.
Phase II: Determination of Phototoxicity and Primary Irritancy
-Design: On each arm, 4 test sites were used with a 5th site serving as a control (no test material applied). Day 1: each testing site had 0.3g of a 50% w/w MRD-88-296 (in U.S.P. Petrolatum) solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing. Day 2: After 24 hours, participants returned and had 0.3 ml of a neat solution of MRD-88-296 (or water if control) applied to the same sites, which was removed after 10 minutes. The right arm was exposed to 15 min UVA and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48, and 72 hours for an examination for dermal irritation.
Phase III - Determination of Photocontact and Contact Allergenic Capabilities
-Design: On each side of the back, 9 test sites were used for experimental purposes with a 10th site serving as a control (no test material applied). The left side of the back was used to evaluate the irritant and contact allegenic propensities and the evaluation of photocontact allergenic propensities were performed on the right side. 0.3g of a 50% w/w MRD-88-296 solution was used at each experimental site for the evaluation of the propensities.
Results and discussion
- Results of examinations:
- Phase II: Determination of Phototoxicity and Primary Irritancy
-Results: MRD-88-296 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant.
Skin patches exposed to MRD-88-296 displayed no signs of skin irritation. The dermal irritation scores were 0 for all subjects (26 people), on all days of exposure to MRD-88-296. A faint erythema (score of 1) was observed in skin patches exposed to MRD-88-296 and UV light for most subjects, however subjects exposed to only UV light displayed a similar erythema (score of 1).
Phase III - Determination of Photocontact and Contact Allergenic Capabilities
-Results: MRD-88-296 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. No erythema was observed during the rechallenge phase of exposure (score of 0 for all subjects).
Applicant's summary and conclusion
- Conclusions:
- Based on these data and results, MRD-88-296 would not be classified as a dermal irritant or as a dermal sensitizer.
- Executive summary:
This study was conducted to determine the potential of MRD-88-296 to cause dermal irritation and sensitization in humans with or without UV irradiation. Twenty-eight humans were exposed to MRD-88-296. Dermal examinations occurred after exposures (day 1 and day 2) and then at 24h, 48h, and 72h post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" or slight erythema. MRD-88-296 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-296 showed no evidence of being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen. Based on these data and results, MRD-88-296 would not be classified as a dermal irritant or as a dermal sensitizer.
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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