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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
Irritation:
- skin: not irritant (OECD 404)
- eyes: not irritant (OECD 405)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain / quality: New Zealand White Al1077 IN RA (SPF)
- Source: Centre Lago S.A., 01540 Vonnas, France
- ldentification: Ear tattoo
- Age at study initiation: about 6 - 7 months
- Weight at study initiation: 3.52 kg - 3.89 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimni Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day); ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 3 (2 females, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: Flank of animal
- Site preparation: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Type of wrap if used: test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Lutrole and Lutrole : water (1 : 1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
The evaluation of skin reactions is performed according to the guidelines:
Erythema and eschar formation
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to eschar formation preventing grading of erythema
Edema formation
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)
Description of any dermal findings not covered by this scale were recorded. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Slight erythema (ER) was observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema.
- Interpretation of results:
- GHS criteria not met
Reference
Results:
Readings | Animal | Erythema | Edema | Additional findings |
1 h | 1 | 1 | 0 | |
2 | 1 | 0 | ||
3 | 1 | 0 | ||
24 h | 1 | 0 | 0 | |
2 | 0 | 0 | ||
3 | 1 | 0 | ||
48 h | 1 | 0 | 0 | |
2 | 0 | 0 | ||
3 | 0 | 0 | ||
72 h | 1 | 0 | 0 | |
2 | 0 | 0 | ||
3 | 0 | 0 | ||
mean 24 - 72 h | 1 | 0.0 | 0.0 | |
2 | 0.0 | 0.0 | ||
3 | 0.3 | 0.0 | ||
mean | 1 | 0.1 | 0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain / quality: New Zealand White A1077 INRA (SPF)
- Source: Centre Lago S.A., 01540 Vonnas, France
- Identification: Ear tattoo
- Age at study initiation: About 3 - 4 months
- Weight at study initiation: 2.82 kg -2.99 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm^2
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day); ad libitum
- Water (e.g. ad libitum): Tap water ad libitum; ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Air changes (per hr): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- physiological saline
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (2 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, tap water
- Time after start of exposure: 24 h
SCORING SYSTEM:
The evaluation of eye irritation is performed according to the guidelines:
Cornea opacity (op): Degree of density (the most dense area is taken for reading)
0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacreous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
Area of cornea involved (the assessment of these ocular reactions is performed independent of the quoted guidelines):
1 = >0<=1/4
2 = >1/4<1/2
3 = >1/2<3/4
4 = >3/4
Iris:
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = No reaction to Iight, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness (red): Refers to palpebral and bulbar conjunctivae, cornea and iris
0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible
3 = Diffuse beefy red
Chemosis (sw): Lids and/or nictitating membranes
0 = No swelling
1 = Any swelling above normal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = SweIling with lids about half closed
4 = Swelling with Iids more than half closed
Discharge (the assessment of these ocular reactions is performed independent of the quoted guidelines):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
Description of any ocular findings not covered by this scale were recorded. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight to moderate conjunctival redness (1 and 24 h) and slight discharge (1 h) were observed initially for 24 h at maximum. The ocular reactions were reversible in all animals within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 0.3 for conjunctival redness and 0.0 for chemosis.
- Interpretation of results:
- GHS criteria not met
Reference
Animal 1: female, 2.82 kg
Animal 2: male, 2.84 kg
Animal 3: female, 2.99 kg
Results.
Readings | Animal | Cornea | Iris | Conjunctival | Symptoms | |||
Opacity | Area | Erythema | Chemosis | Discharge | ||||
1h | 1 | 0 | 0 | 0 | 1 | 0 | 1 | |
2 | 0 | 0 | 0 | 2 | 0 | 1 | ||
3 | 0 | 0 | 0 | 1 | 0 | 1 | ||
24 h | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
48 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
72 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.3 | 0.0 | |||
2 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
3 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
mean | 1 | 0.0 | 0.0 | 0.3 | 0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Irritation to skin was evaluated in a study performed under GLP according to guidelines OECD 404, EU Method B.4 and EPA OPPTS 870.2500 (BASF, 2002). Thereby, test patches containing 0.5 mL of di-(2-propylheptyl) phthalate (purity: 99,2 % (sum of isomers)) were applied to the flanks of one male and two female White New Zealand rabbits for 4 hours. The skin sites were evaluated for erythema/eschar and edema formation 1, 24, 48 and 72 hours following removal of the patches. At one hour following patch removal, slight erythema was observed in all animals and persisted in one animal up to 24 hours, but within 48 hours after patch removal, these skin reactions were reversed. The resulting mean irritation scores for 24-72 hours were 0.1 for erythema/eschar and 0.0 for edema, respectively. Thus, di-(2-propylheptyl) phthalate was found to be not irritating to the skin.
In another study, the test sites on the backs of six albino rabbits were clipped free of hair and one side was abraded to allow the substance to penetrate the stratum corneum (Biosearch, Inc., 1982). Then, 0.5 g mixture of 91.3% di-(2-propylheptyl) phthalate and 8.7% 2-propylheptyl/4-methyl-2-propylhexyl and di-(4-methyl-2-propylhexyl)phthalate was applied and covered with gauze, which was removed 24 hours later. The treated areas were examined for erythema, eschar and edema formation using the Draize scale where zero corresponded to no irritation. A second examination was conducted 72 hours following the removal. As result, the scores for erythema and edema, as well as the primary skin irritation score were found to be 0. Thus, no irritation to skin was found.
Eye irritation
Irritation to eyes was tested in a study, which was performed under GLP according to guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400 (BASF, 2002). A single ocular application of 0.1 mL of di-(2-propylheptyl) phthalate (purity: 99,2% sum of isomers) was given to one male and two female White New Zealand rabbits and washed out 24 hours later by rinsing with water. The resulting ocular reactions were scored 1, 24, 48 and 72 hours after application. Slight to moderate conjunctival redness and slight discharge were observed up to 24 hours following instillation, but these reactions were reversible in all animals within 48 hours. The average irritation score was 0.0 for corneal opacity, iris effects and chemosis. The conjunctival redness score was 0.3. Thus, di-(2-propylheptyl) phthalate was found to be not irritating to eyes.
In another study, 0.1 g of 91.3% di-(2-propylheptyl) phthalate and 8.7% 2-propylheptyl/4-methyl-2-propylhexyl/di-(4-methyl-2-propylhexyl)phthalate was instilled into the right eyes of six young adult albino rabbits (Biosearch Inc., 1982). While no removal by rinsing was reported, ocular reactions including irritation of the cornea, iris and conjunctivae were examined 1, 24, 48, 72, 120, and 168 hours following the administration. As result, a primary irritation score of 0.0 for all effects was reported. Thus, the tested phthalate mixture was not irritating to eyes.
Justification for classification or non-classification
Based on the available data for skin and eye irritation the test item is not classified according to Regulation (EC) No 1272/2008.
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