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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-216-0 | CAS number: 2082-79-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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: Well documented study report which meets basic scientific principles, acceptable with restrictions (second challenge not performed)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 400-450 g
- Housing: single
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG, Gossau SG
- Water (e.g. ad libitum): tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14 - Route:
- intradermal
- Vehicle:
- other: polyethylene glycol + saline (70 : 30 parts)
- Concentration / amount:
- 0.1 %
- Route:
- intradermal
- Vehicle:
- other: polyethylene glycol + saline (70 : 30 parts)
- Concentration / amount:
- 0.1 %
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period: 3 weeks
- Test groups: During the 1st week volumes of 0.1 ml of the test substance without adjuvant were injected intradermally on Monday at two sites (flank and back), and on Wednesday and Friday at each one site on the back. Twenty-one hours after administration, the animals were chemically depilated with Butoquick and three hours later the skin reaction was assessed under artificial lighting. The two largest diameters of the erythematous reaction in vertical alignment were measured (mm) and the skin-fold thickness was determined with a skin-fold gauge (mm). The individual "reaction volume" (µl) was calculated from these values for each reaction from each animal. During the second and third week of induction the substance was mixed with adjuvant in a 1:1 ratio. A total of 6 sensitizing doses of 0.1 ml were injected intracutaneously into the skin of the neck on Monday, Wednesday and Friday. The reactions were not evaluated on these occasions.
- Control group: treated in the same manner with the control vehicle alone (20 guinea pigs)
- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the last sensitizing treatment with the adjuvant mixture.
- Test groups: 0.1 ml of the same substance formulation, as employed during the first testing week, was injected intradermally on the previously untreated flank. Twenty-four hours later the reaction site was evaluated in the same manner as during the first testing week.
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24
Skin sensitization was defined to occur of the challenge reaction whenever the reaction volume exceeded the mean value + one SD of the 4 pre-sensitization responses. - Challenge controls:
- A group of 20 guinea pigs treated in the same manner with the control vehicle alone served as negative and another group treated with Dinitrochlorobenzene (DNCB) as positive controls
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
- Statistics:
- The number of positive animals in each group was counted with significant differences between treated and control groups assessed by the Fisher test.
- Positive control results:
- All guinea pigs treated with Dinitrochlorobenzene (DNCB) exhibited positive reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 %. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance is considered to possess no skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
Reference
Rate of positive reactions: Test item, polyethylene glycol + saline and DNCB treated groups and p = level of significant difference with control group:
Compound |
Rate of positive reactors |
P |
polyethylene glycol + saline |
1/20 |
>0.01 |
DNCB |
20/20 |
<0.001 |
test item |
4/20 |
>0.01 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance was tested using Maurer Optimisation Test with 8 induction exposures (intradermally, 0.1 %) and one challenge exposure two weeks later with the same concentration (CIBA-GEIGY 1976). No second challenge with non-irritating concentration was performed. The test resulted in 4 positive reactors in the test group and 1 positive reactor in the control group. All animals showed positive reactions in the positive control group.
In a human patch test (CIBA-GEIGY 1963) performed with 58 volunteers (15 males and 43 females, 16-73 years of age), 0.5% of the test material in dimethyl phthalate causes little irritation. Only one of 58 subjects became sensitive to the test material during the test. This subject had reported an earlier dermatitis following use of cuticura. Therefore the overall results can be considered as negative. Based on the results, the test substance possess no skin-sensitizing (contact allergenic) potential.
Migrated from Short description of key information:
The substance caused no skin sensitization in the Maurer Optimization test in guinea pigs (Ciba-Geigy 1976).
Justification for selection of skin sensitisation endpoint:
Well documented study report
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No experimental data is available regarding respiratory sensitization. In the absence of skin sensitization, respiratory sensitization is not expected.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.
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.