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Diss Factsheets
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EC number: 258-469-4 | CAS number: 53306-54-0
- 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
Endpoint summary
Administrative data
Description of key information
Sensitization:
- skin: not sensitizing (modified Buehler test)
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
- Study period:
- From 31 May 1979 To 11 Jul 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- occlusive patch held for 24 hours instead of 6 hours; 10 instead of 20 animals
- Principles of method if other than guideline:
- Modified Buehler-test with 10 inductions
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 300 and 400 g
- Housing: housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR part 3 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%; 0.5 g
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%; 0.5 g
- No. of animals per dose:
- 5 male and 5 female
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 20 d
- Test groups: 10 animals
- Control group: no
- Site: the same intact skin test site
- Patch: gauze patch was placed over the treated area and an impervious material was wrapped tightly around the trunks of the animals to hold the patch in place.
- Frequency of applications: every second day
- Duration: 24 h
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: after a 14 day rest period
- Exposure period: 24 h
- Test groups: 10 animals
- Control group: no
- Site: other skin site than used for induction
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 h
SCORING
Sites were examined for irritation (if any) using the Draize Method of Scoring. - Challenge controls:
- no
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
Reference
Individual scoring:
Animal | Sex | Irritation | Readings after application No. | Challenge | ||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 24 h | 48 h | |||
1 | M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 | M | Erythema | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | M | Erythema | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 | M | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
5 | M | Erythema | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
6 | F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
7 | F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
8 | F | Erythema | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
9 | F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
10 | F | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The test substance was not a primary irritant. It is not a skin sensitizer.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Buehler test
An in vivo study where sensitization to skin was evaluated on five male and five female albino guinea pigs that were treated with 0.5 g of di-(2 -propylheptyl) phthalate of 91.3% purity [8.7% 2-propylheptyl/4-methyl-2-propylhexyl/di-(4 -methyl-2 -propylexyl) phthalate] on the shaved skin of their backs covered by gauze patches was conducted (Biosearch Inc. 1982). Following 24 hours contact, the patches were removed and patches with fresh sample were then applied. This procedure was then repeated 10 times. After a following rest period of two weeks, a challenge dose was applied to skin sites different from the original test sites for 24 hours. Resulting irritation effects were evaluated 24 hours after each initial exposure, and 24 and 48 hours after the challenge application using the Draize method. Since no animals showed erythema or edema after 24 and 48 hours, di-(2-propylheptyl) phthalate was found to be not sensitizing to skin.
QSAR
This result is supported by an in silico study. The structure of Di-(2-propylheptyl)phthalate did not give any indication for sensitizing properties (for both the parent and metabolites) by using a quantitative structure-activity relationship (QSAR): the validated OASIS-LMC.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
QSAR indicated no skin sensitizing potential. Due to the negative result in a modified Buehler test, no classification according to GHS criteria is warranted.
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