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EC number: 271-678-5 | CAS number: 68603-87-2
- 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
Dicarboxylic acid mixture is slightly irritating to the skin. It is highly irritating to the eye with symptoms not reversible within 21 days. Respiratory irritation in animals is not sufficiently examined. Due to the acidic character of the dicarboxylic acid mixture, a local irritation potential in the respiratory tract cannot be excluded.
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
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically defensible or guideline method was used, no GLP
- Guideline:
- other: US Federal Hazardous Sustances Act
- Deviations:
- not specified
- Remarks:
- for further details, see below
- Principles of method if other than guideline:
- 0.5 g applied as finely ground sample moistened with water
Study was conduced according to Federal Hazardous Substance Act - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Other effects:
- Slight scabbing at lines of abrasions.
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
- Executive summary:
In a skin irritation study according to the US Federal Hazardous Substance Act with limited documentation 500 mg of a dicarboxylic acid mixture moistened with water was applied to the shaved intact or abraded skin of six rabbits, respectively, for 24 h. Slight scabbing at line of abrasion was observed. Mean scores for erythema or oedema after 24, 48 and 72 were 1.2 or 0.43, respectively. All effects were reversible by day 7.
Reference
The individual scores of 3 animals were shown; the other three treated animals show comparable effects.
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
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically defensible or guideline method was used, no GLP
- Guideline:
- other: US Federal Hazardous Substance Act
- Deviations:
- not specified
- Remarks:
- for further details see below
- Principles of method if other than guideline:
- 30 mg test compound was applied as finely ground sample (Dosage equivalent to 0.1 ml)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not determined
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not determined
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not determined
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 10 - <= 15
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 10 - <= 40
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0 - <= 5
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 5 - <= 10
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 5 - <= 10
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 5 - <= 10
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 14 - <= 16
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 14 - <= 16
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 14 - <= 16
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Other effects:
- Day 21: Slight ulceration in three instances, slight to moderate discharge; nictitating membrane not visibel
- Interpretation of results:
- moderately irritating
- Remarks:
- Criteria used for interpretation of results: other: Federal Hazardous Substance Act
- Conclusions:
- Test material was irritating to the eye; the observed effects were not fully reversible within 21 days.
- Executive summary:
In an eye irritation study performed again according to the US Federal Hazardous Substance Act in the same laboratory six rabbits were dosed with 30 mg dicarboxylic acid mixture for 24 hours. Severe erythema and slight edema and copious discharge was observed 10 minutes after installation. After 1 and 24 hour the following observations were recorded: translucent to opalescent areas of corneal cloudless, iris showed sluggish/no reaction to light, slight to moderate edema, copius discharge. The effects gradually improved between 48 and 168 hours but were not reversible after 21 days (slight ulceration in three instances, slight to moderate discharge; nictitating membrane not visible).
Reference
The individual scores of 3 animals were shown; the other three treated animals show comparable effects.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
In a skin irritation study according to the US Federal Hazardous Substance Act with limited documentation 500 mg of dicarboxylic acid mixture moistened with water was applied to the shaved skin of six rabbits, respectively, for 24 h. Slight scabbing at line of abrasion was observed. Mean scores for erythema or oedema after 24, 48 and 72 were 1.2 or 0.43, respectively. All effects were reversible by day 7 (Birch 1979).
Additional skin irritation studies are available. In one experiment 2 rabbits were occlusive dosed with dicarboxylic acid mixture for 20 h. Scores were evaluated at 24, 48 and 72 h. No edema were observed for both animals and mean erythema scores were 2 and 1,33 for animal 1 and 2, respectively. The effects were not fully reversible in animal 1 at the end of the experiment, day 8 (BASF 1973). In another experiment six rabbits were treated with the 0.5 ml liquid test substance (50% solution) for 24 h using occlusive conditions on the intact and scarified skin. The animals were observed for 7 days. No erythema or edema were observed in any animal.
In an eye irritation study performed according to the US Federal Hazardous Substance Act six rabbits were dosed with 30 mg dicarboxylic acid mixture for 24 hours. Severe erythema and slight edema and copious discharge was observed 10 minutes after installation. After 1 and 24 hour the following observations were recorded: translucent to opalescent areas of corneal cloudless, iris showed sluggish/no reaction to light, slight to moderate edema, copius discharge. The effects gradually improved between 48 and 168 hours but were not reversible after 21 days (slight ulceration in three instances, slight to moderate discharge; nictitating membrane not visible). Two additional studies confirm that dicarboxylic acid mixture induces severe eye irritation not reversible within the observation time of 8 days (BASF 1973, 1979).
Additional sources/reviews cited in chapter "Additional Toxicological Information" support that dicarboxylic acid mixture is not/slightly irritating to the skin and irritating to the eye.
Respiratory irritation in animals is not examined, however, due to the acidic character of the dicarboxylic acid mixture, a local irritation potential cannot be excluded. No evidence of respiratory tract irritation was reported for adipic acid in an acute inhalation study where 20 rats were exposed to up to 7700 mg/m3 of adipic acid dust (MMAD 3.5 µm) for 4 hours (BASF 1981).
Reliable human data are not available in the literature. In one study the authors reported that clouds of adipic acid and other materials were routinely generated during charging of reaction vessels. In 7 of 12 workers exposed (for an average of 9.2 years) to various glycols, glycerine, other compounds, and adipic acid dust particles (8 h average concentration 0.47-0.79 mg/m3 [0.08-0.13 ppm]) complained of mucosal irritation (eye, nose, and throat). There was no local exhaust ventilation and the workers did not wear respiratory protection (Cummings and Roseman 1985). Due to the limitations mentioned this study is not reliable and can not be used to derive a threshold for local irritation.
A Threshold Limit Value (TLV-TWA) of 5 mg/m3 was established for adipic acid by the American Conference of Governmental Industrial Hygienists (ACGIH) in 2001, based on the data reported by Krapotkina et al (1981) that the threshold for irritation of the human eye was 20 mg/m3. Clinical examinations of worker engaged in adipic acid manufacture found that inhaling adipic acid produced functional disorders of the autonomic nervous system and gastrointestinal tract and in the mucosa of the upper respiratory tracts.
Supported by occupational medical experiences with adipic acid , glutaric acid and succininc acid available within the lead company, Lanxess, the dicarboxylic acid mixture is allocated to the moderate hazard band. Regularly, medical examination of the staff (7 persons) is performed. Examination includes medical history, physical examination, lung function, ECG/Ergometry, vision-testing and audiometry. Occupational medical surveillance did not reveal any health effects like irritations of the eyes, skin, mucosa membranes or upper respiratory tract which could be derived to be from possible exposure at workplace. Parallel to the medical examination the concentration of those hazardous substances in the air at the workplace were determined. The maximum concentration of adipic acid and glutaric acid were 11.6 mg/m3 and 1.23 mg/m3, respectively, between 2006 and 2009 (Currenta 2010).
Effects on eye irritation: severe eye damage
Justification for classification or non-classification
Dicarboxylic acid mixture should be classified with R41 "risk of serious damage to eyes" according to the current classification criteria 67/548/EWG and as an eye irritant Category 1 "irreversible effects on the eye" according to regulation no. 1272/2008 (GHS).
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