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EC number: 205-011-6 | CAS number: 131-11-3
- 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
DMP is not irritating to skin and eyes. No data are available for the respiratory system.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is reliable with restrictions due to limited reporting (non-GLP study). Basic data are given and study is sufficient for endpoint evaluation.
- Principles of method if other than guideline:
- Method: historical Method according to Draize et al. (1944). See any further information on materials and methods for details.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethyl phthalate
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data - Species:
- rabbit
- Strain:
- other: only mentioned: albino rabbit
- Details on test animals or test system and environmental conditions:
- no details reported
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml neat test substance; density =1.194 g/ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24-72h reading
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: patch size 2.5 x 2.5cm, four patches are placed at the back of the animal, 10cm apart
- Type of wrap if used: rubberized cloth, wrapping the whole animal trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24h patch exposure
SCORING SYSTEM: "the primary irritation index" according to Draize etal. (1948) - Irritation parameter:
- overall irritation score
- Remarks:
- skin
- Basis:
- mean
- Time point:
- other: 24-72h combined average
- Score:
- 0.7
- Reversibility:
- other: no substance-related effects
- Remarks on result:
- other: combined average is based on averages from intact and abraded rabbit skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not cause skin irritation but irritation of mucous membrane.
The test substance is not irritating to the skin. - Executive summary:
The study was conducted according to the method described by Draize et al. (1944) and is reliable with acceptable restrictions. Restrictions are due to limited reporting in times befor GLP. Skin irritation was tested in albino rabbits in vivo. Neat test substance (0.5ml unchanged, no vehicle) was applied on abraded and intact skin (occlusive) for 24h (reading 24 -72h).
The test substance is not irritating to the skin.
Reference
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:
- other: The study was conducted according to OCED TG 405 under GLP conditions and is fully sufficient for endpoint evaluation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethyl phthtalate
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: Lab. Jo 16969
- Stability under test conditions: no data
- Storage condition of test material: no data - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Gaukler, D-6050 Offenbach/Main
- Age at study initiation: not reported
- Weight at study initiation: mean M 3.04 kg; mean F 2.60 kg
- Housing: cages made of stainless steel with wire mesh ealk floors, floor area 40 x 51 cm; fully air conditioned rooms
- Diet: about 130g per animal per day, Kliba 341, 4mm (Klingenthalmühle AG, Ch-4303 Kaiseraugst)
- Water: ad libitum
- Acclimation period: at least 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): not reported, room fully air conditioned
- Photoperiod (hrs dark / hrs light): 12/12 (06.00 - 18.00/18.00 - 06.00) - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.1 ml - Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h after application
- Number of animals or in vitro replicates:
- 3 (2M/1F)
- Details on study design:
- Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing: no washing done
SCORING SYSTEM: according to 83/467/EEC - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: 1 animal with score 2 at 1h, but fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The neat substance is not irritating to the eyes.
- Executive summary:
The study was conducted according to OCED TG 405 under GLP conditions. 3 (2M/1F) White vienna rabbits were tested for eye irritation after application of thest substance (1 -24 -48 -72h reading). No irritation or corrosion score was observed for iris and cornea. The 24 -48 -72h irritation score for conjunctiva redness was 0.3, no chemosis was observed. Effects were fully reversible within 72h.
The neat substance is not irritating to the eyes.
Reference
Table 1: Animal numbers and weights
Animal |
1 |
2 |
3 |
Animal No. |
0962 |
0973 |
0975 |
Animal weight |
3.02 |
2.06 |
3.06 |
Sex |
M |
F |
M |
Table 2: Cornea, iris and conjunctiva scores:
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
OP |
AR |
RED |
SW |
DI |
|||
1h |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
1h |
2 |
0 |
0 |
0 |
2 |
0 |
1 |
1h |
3 |
0 |
0 |
0 |
1 |
0 |
0 |
24h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
24h |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
24h |
3 |
0 |
0 |
0 |
1 |
0 |
0 |
48h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
48h |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
48h |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
72h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
72h |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
72h |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
mean |
1 |
0.0 |
0.0 |
0.0 |
0.7 |
0.0 |
0.0 |
mean |
2 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
mean |
3 |
0.0 |
0.0 |
0.0 |
0.3 |
0.0 |
0.0 |
mean |
1-3 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Legend:
KEY:
MA = MALE
FE = FEMALE
SCALE FOR SCORING OCULAR LESIONS:
CHEMOSIS (SW) AND CORNEA (OP) (OPACITY-DEGREE OF DENSITY):
0 = NONE 1
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 VERY SEVERE
CONJUNCTIVAE REDNESS (RED):
0 = NORMAL
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
IRIS:
0 = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS
AREA OF CORNEA INVOLVED (AR):
1 = > 0; 1/4
2 = >= 1/4; 1/2
3 = >= 1/2; 3/4
4 = >= 3/4
DISCHARGE (DI):
0 = NORMAL
1 = SLIGHTLY INCREASED
2 = CLEARLY INCREASED
3 = DISTINCTLY INCREASED
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
DMP was tested according to a method described by Draize et al. [1944] and is reliable with acceptable restrictions. Skin irritation was tested in albino rabbits. Neat test substance (0.5 ml unchanged, no vehicle) was applied on abraded and intact skin (occlusive) for 24 h (reading 24 -72 h). Readings were also performed after 72 hours and the final score represents, an average of the 24- and 72-hour readings. The combined average is referred to as "the primary irritation index" and is useful for placing compounds in general groups with reference to their irritant properties. The overall irritation score was 0.7 (24 -72h combined average), no irritation of the skin was observed. There is also human evidence as reported by BASF test [BASF AG, unpublished report, 1948] where DMP did not cause irritation in a patch test, and another study [Frosch et al., 1977] reported no irritation in a ”stinging assay”.
Eye irritation:
DMP was tested for eye irritation according to OCED TG 405 under GLP conditions in an BASF study [study No. 11H0540/902146, 1990]. Three (2M/1F) White rabbits were tested for eye irritation after application of test substance, reading was done after 1 -24 -48 -72 h according to the Draize scoring system. No irritation or corrosion score was observed for iris and cornea. The 24 -48 -72 h irritation score for conjunctiva redness was 0.3, no chemosis was observed. All effects were fully reversible within 72h. Therefor, DMP is considered to be not irritating to the eyes. Lawrence et al. [1975] also reported that DMP causes no eye irritation in rabbit.
However, there are some findings on eye irritation in a test described by Draize et al. [1944] in rabbits. But irritation is assessed only after 1 and 24 h in this study, reversibility is not examined. Carpenter and Smyth [1946] reported weak irritation (2/10 points) based on their own scoring system using 0.5 ml neat substance. It must be mentioned that the OECD TG 405 on “acute eye irritation and corrosion” recommends 0.1 ml at maximum.
Respiratory irritation:
There are no data available for respiratory irritation.
Conclusion:
The test substance did not cause skin or eye irritation.
Justification for classification or non-classification
GHS classification (GHS UN rev.2, 2007):
- Skin corrosion/irritation: no classification required
- Serious eye damage/eye irritation: no classification required
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