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EC number: 203-593-6 | CAS number: 108-55-4
- 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
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:
- supporting study
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 3 minute and 1 hour exposure periods assessed. Separate animals used for each exposure period.
- Principles of method if other than guideline:
- The study was conducted in a similar manner to the OECD guideline, although only the 3 minute and 1 hour exposure periods assessed (due to the 4 hr exposure being covered in an additional study). There is no evidence in the report that the study was conducted according to GLP, however it appears to have been conducted in the spirit of GLP. Sufficient animals were used and the appropriate methodology used to assess the endpoint.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 3 minutes or 1 houre
- Observation period:
- 7 days
- Number of animals:
- 2 rabbits exposed for 3 minutes
6 rabbits exposed for 1 hour - Irritation parameter:
- erythema score
- Remarks:
- following one-hour contact
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- following one-hour contact
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- following 3-minute contact
- Basis:
- mean
- Remarks:
- one male and one female
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- following 3-minute contact
- Basis:
- mean
- Remarks:
- one male and one female
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None - no erythema, edema or other skin effects noted in any of the rabbits during the 7 day observation period.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- On the basis of this study it can be concluded that following a 3 minute or 1 hour occluded exposure, the test material was not corrosive. However as recorded in an additional study where the exposure duration was 4 hours, the substance was demonstrated to be severly irritating.
- Executive summary:
In previous skin irritancy test glutaric anhydride produced necrosis on 3 of 6 animals from 4 hours of occluded contact with 0.5 ml (BRRC Report 51-88). Therefore, further testing, using 2 shorter periods of occluded contact (one hour; 3 minutes), was conducted. A one-hour application of glutaric anhydride to covered rabbit skin resulted in no irritation on any of 6 rabbits. A 3- minute application of 0.5 ml did not produce any irritation on 2 of 2 animals tested. Therefore, glutaric anhydride was not "corrosive" to the skin in either the one-hour or the 3-minute test.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Study considered only the 4 hr timepoint, no GLP
- Principles of method if other than guideline:
- Primary skin irritancy test appears to have been conducted in a similar manner to current guidelines although but only one exposure period was used (4 hr) rather than 3 minute, 1 hour and 4 hours. No evidence that GLP was conformed to although it appears to have been conducted 'in the spirit' of GLP.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days - observations at 5 hours, 1,2,3 and 7 days
- Number of animals:
- 6; 3 male and 3 female
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 5 hours
- Score:
- 0.8
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 1.8
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 5 hours
- Score:
- 0.2
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 2
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 1.3
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.2
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- other: desquamation and necrosis
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: no quantification possible
- Other effects:
- Evidence of moderate necrosis observed in 2 animals at day 1 and in an additional animal at day 2. This persisted until the end of the observation period. Desquamation was also observed in all animals at day 7.
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The overall scores for skin irritation (erythema and edema) observed in this study are inicative of an irritation response. Since necrosis was also observed it is clear that this substance is highly irritant. However the necrosis does not appear to have involved full thickness destruction of the skin thus it does not meet the criteria for corrosive. This substance is therefore Highly irritating.
Referenceopen allclose all
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
- Study period:
- 1988
- 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 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored accoridng to Draize scoring system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- Dose applied directly to eyes. No indication of duration of exposure and no indication that eyes were washed after dosing. Thus it is not possible to accurately state the duration that the animals were exposed to the test substance.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.3
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 0.8
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.5
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 2.2
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 2.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.8
- Max. score:
- 2
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0.6
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 2.3
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.3
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance appears to have caused severe damage to the eyes that persisted through the first 72 hours after dosing. All lesions subsequently heald over the course of the observation period with no damage present at day 21. Due to the severity of the initial lesions and their persistance for more than 24 hours, this test material meets the criteria for classification as an eye irritant that may cause serious damage to the eyes.
Reference
Instillation of 10 mg of sample into rabbit eyes resulted in moderate to severe corneal injury (opacity) in 5 of 6 animals. One treated eye had no corneal effects. Iritis was apparent in 6 eyes and moderate to severe conjunctival irritation developed in 6 rabbits. After 48 hours, all rabbits exhibited a pus-like ocular discharge. Two eyes had a normal appearance after 7 days. Corneal vascularization developed in one rabbit and another animal exhibited a hemorrhaged nictitating membrane. One animal died at 12 days. The treated eye of this animal had completely healed by 7 days. The death was not considered to be related to the treatment. By 14 days, 2 of the remaining 5 eyes had a normal appearance. Two others only had minor conjunctival irritation. All eyes were healed after 21 days.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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