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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-607-5 | CAS number: 85-44-9
- 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
In 2 valid skin irritation studies, phthalic anhydride was found
slightly/moderately irritating (Thyssen, Muermann). In 2 reliable
published studies the test substance was characterised as not irritating
or slightly irritating.
In a valid eye irritation study with phthalic anhydride conjunctivae
effects were not reversible within 7 days (observation period)
(Thyssen). Published studies found phthalic anhydride
irritating/extremely irritating.
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: Limited documentation, no data on compound purity, animals were dosed at the ear for 24 hours
- Principles of method if other than guideline:
- 1 male + 1 female New Zealand White rabbit, ear, 500 mg/rabbit moisted with water, fixed with a tape, exposure time: 24 h, then cleaning with water, soap and oil, post exposure observation time: 14 days
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- White New Zealand rabbits, weight 3 - 4 kg
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: moisted with water
- Controls:
- not required
- Amount / concentration applied:
- Amount: 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- No further data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 0, 2 d, 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score was 0 at any time point
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- no data
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Method: application of 500 mg/animal of the test substance at the inside of rabbit ears of 2 animals
Result: substance is not irritating, no edema and no erythema was seen at any time point
Reference: Thyssen/Bayer AG (1979)
Reference
Both rabbits: no reaction was observed (score: 0).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Observation time 7 days, short documentation, low dose 50 mg
- Principles of method if other than guideline:
- 1 male and 1 female New Zealand white rabbit, 50 mg/rabbit was applied into the conjunctival sac of one eye of each rabbit, observation time: 7 days, evaluation according Draize
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- White New Zealand rabbits, weight 3-4 kg
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount: 50 mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- No further data
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: not measured/tested
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Other effects:
- no data
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
Method: 2 animals received a dose of 50 mg/animal in the conjunctival sac, postexposure period 7 days.
Result: Not fully reversible within 7 days, cornea temorarily in parts opaque.
Reference: Thyssen/Bayer AG (1979)
Reference
Scores:
rabbit1 - rabbit2
cornea (maximal score 4):
1h: 1 - 1
24h: 1 - 1
day 2: 1 - 0
day 7: 0 - 0
transitional slight cloudiness of the cornea
Iris (maximal score: 2):
1h: 1 - 1
24 h and later: 0 - 0
conjunctiva, redness (maximal score 3):
1h: 2 - 2
24h: 1 - 2
day 2: 1 - 1
day 7: 1 - 1
conjunctiva, swelling (maximal score 4):
1h: 2 - 1
24 h and later: 0 - 0
lacrimation:
1h: 1 - 1
24 h and later day 14: 0 - 0
The cornea was temporary cloudy. The observed effects were not fully
reversible during the 7 days observation period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion and eye irritation is covered by several studies. The most reliable studies for skin irritation stated the test substance as slightly/moderately irritating. Also for eye irritation the most valid study stated phthalic anhydride as irritating.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
According to the harmonized classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) phthalic anhydride is classified as Skin Irrit. 2 (H315) and Eye Dam. 1 (H318).
This classification will be adopted.
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.