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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-365-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983/05/10-1983/05/03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 406.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983/05/10-1983/05/03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 406.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Clinical observations:
- Slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 15.0. Clinical observations: Slight erythema (score of 1 for all + animals).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals except one that scored 2)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals except one that scored 2).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C9, aromatics based on analogue read across.
A Hartley dermal sensitization test was conducted on 30 guinea pigs. Following a preliminary irritation test, 15 Hartley guinea pigs were treated by intradermal injection (0.01 mL; 5.0% (w/v) vehicle/MRD-83 -208 or with adjuvant) to induce sensitization and then further sensitized by dermal application of 0.5 ml MRD-83 -208 a week after the intradermal injection. Guinea pigs were challenged two weeks later by topical application (0.5 ml 0.5% MRD-83 -208).
No indication of sensitization was noted.
Based on the scored of dermal irritation, test substance MRD-83 -208 would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Summary of other skin sensitisation studies
End Point | Study Reference | ||||||||||||||||||||||||
REACH requirement | IUCLID Section | Study Name | Data Waiving | Waiving Justification | Species | Study Result Type | Test Guideline/Qualifier | Test Guideline/Guideline | Test Guideline/Deviations | Reliability | Rational For Reliability | GLP Compliance | Test Materials/Identity | Study Result | Reference Type | Reference Author | Reference Year | Reference Title | Bibliographic Source | Testing Laboratory | Reference Report No. | Owner Company | Company Study No. | Report Date | Data access |
8.3 Skin sensitization | 7.4.1 | Skin Sensitization | guinea pig | Experimental result | Equivalent or similar to | Magnusson, B., and Kligman, A.M., (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm.,52, 268-276. | 2 | Summary only of study. | No data | Shellsol A | not sensitizing | Study report | Coombs, AD, Blair, D, Doak, SM, Carter, BI | 1977 | The Acute Toxicity of Shellsol A | HSPA0687 | Sittingbourne Research Centre | M(T)-1-77 | Shell Chemicals Europe BV | June, 1977 | yes |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles.
Test material
- Reference substance name:
- Hydrocarbons, C9, aromatics
- EC Number:
- 918-668-5
- Molecular formula:
- C9H12
- IUPAC Name:
- Hydrocarbons, C9, aromatics
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Dutchland, Inc.
- Sex: Female (30)
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 352-437 g
- Housing: Individually
- Diet (e.g. ad libitum): Purina Guinea Pig Chow (pellets), ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Primol 185 (injection); neat (dermal application)
- Concentration / amount:
- Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Primol 185 (injection); neat (dermal application)
- Concentration / amount:
- Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat
- No. of animals per dose:
- Control: Female (15)
Treatment: Female (15) - Details on study design:
- INDUCTION EXPOSURE
INTRADERMAL INJECTION (DAY 0)
Site: 3 injections (0.1 ml/injection) on both sides of the spinal cord for a total of 6 paired injections
- Site 1: diluted FCA to both treated and control groups
- Site 2: 5.0% MRD-83-208 diluted in vehicle; and undiluted vehicle to control animals
- Site 3: Concentration: 5.0% MRD-83-208 in diluted FCA (adjuvant); and 5.0% vehicle in diluted FCA to the control group
INDUCTION BY OCCLUSIVE TOPICAL APPLICATION (DAY 7)
Experimental animals received 0.5 ml neat MRD-83-208 over the injection site under an occlusive wrap and held in place for 48 hrs. Control animals received 0.5 ml vehicle.
CHALLENGE EXPOSURE
Animals were challenged with either 0.5 ml 0.5% MRD-83-208 in vehicle or just vehicle (control group) that was topically applied to the clipped area on the right flank under an occlusive wrap for 24 hrs.
EXPERIMENTAL EVALUATION
Observations for toxicological signs occured immediately after dosing on day 0, 7, 10, 14, 21, and each time dermal observations were made. Body weights were recorded on days 0, 7, 14, 21, and at sacrifice. Dermal evaluations occured 24 hrs after the induction patch was removed (day 10) and 24 and 48 hrs after removal of the challenge patch. Dermal responses were evaluated by the Draize Method. - Challenge controls:
- Vehicle controls were used for each of the induction treatments and for the challenge treatment.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Clinical observations:
- Slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 15.0. Clinical observations: Slight erythema (score of 1 for all + animals).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals except one that scored 2)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals except one that scored 2).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- slight erythema (score of 1 for all + animals)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Summary of other skin sensitisation studies
End Point | Study Reference | ||||||||||||||||||||||||
REACH requirement | IUCLID Section | Study Name | Data Waiving | Waiving Justification | Species | Study Result Type | Test Guideline/Qualifier | Test Guideline/Guideline | Test Guideline/Deviations | Reliability | Rational For Reliability | GLP Compliance | Test Materials/Identity | Study Result | Reference Type | Reference Author | Reference Year | Reference Title | Bibliographic Source | Testing Laboratory | Reference Report No. | Owner Company | Company Study No. | Report Date | Data access |
8.3 Skin sensitization | 7.4.1 | Skin Sensitization | guinea pig | Experimental result | Equivalent or similar to | Magnusson, B., and Kligman, A.M., (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm.,52, 268-276. | 2 | Summary only of study. | No data | Shellsol A | not sensitizing | Study report | Coombs, AD, Blair, D, Doak, SM, Carter, BI | 1977 | The Acute Toxicity of Shellsol A | HSPA0687 | Sittingbourne Research Centre | M(T)-1-77 | Shell Chemicals Europe BV | June, 1977 | yes |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
- Executive summary:
A Hartley dermal sensitization test was conducted on 30 guinea pigs. Following a preliminary irritation test, 15 Hartley guinea pigs were treated by intradermal injection (0.01 mL; 5.0% (w/v) vehicle/MRD-83 -208 or with adjuvant) to induce sensitization and then further sensitized by dermal application of 0.5 ml MRD-83 -208 a week after the intradermal injection. Guinea pigs were challenged two weeks later by topical application (0.5 ml 0.5% MRD-83 -208).
No indication of sensitization was noted.
Based on the scored of dermal irritation, test substance MRD-83 -208 would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)