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EC number: 204-635-6 | CAS number: 123-56-8
- 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
Suitable in vivo studies (OECD 404 and 405) are available to determine the potential of succinimide to induce skin irritation and eye irritation. Based on the results of these studies, the substance can be considered non-irritant to the skin and eye.
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:
- 2000-05-01 to 2000-09-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 29 December 1992
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Samples with approximately 0.5 g of the test substance (the weighed amounts of the individual doses were 497. 500 and 500 mg). were moistened with 1.0 mL deionised water
OTHER SPECIFICS:
- measurement of pH: 4.4 (1% solution in deionized water, v/v, determined with a pH-Meter) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, D-97633
- Age at study initiation: not specified
- Weight at study initiation: Animal No. 1: 2.4 kg, Animal No. 2: 2.2 kg, Animal No. 3: 2.3 kg
- Housing: Optimal hygienic conditions, individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm x 38 cm, with a wooden rest shelf, 15 x 59 cm
- Diet: Altromin 2023 diet for rabbits, ad libitum and hay-briquettes (supplied by SSNIFF, D-59494 Soest) were offered additionally as a dietary supplement
- Water: tap water from an automatical watering system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22 °C
- Humidity (%): average of 61 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- 0.5 g of the test substance were moistened with 1.0 mL deionised water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (the weighed amounts of the individual doses were 497, 500 and 500 mg) were moistened with 1.0 mL deionised water
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 mL deionised water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm at dorsal area of the trunk (dorsal thoracal region).
- Type of wrap if used: Samples of the test substance were spread on cellulose patches and were applied to the test sites. They were held in place by fixing them marginally with non-irritating tapes. The application sites were covered semi-occlusively by a dressing. Access by the animal to the application sites was prevented by a plastic collar.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: duration of exposure was 4 hours. At the end of the exposure period the dressing, the tapes with the patches and the collar were removed, residual test substance was removed with wet Kleenex-tissues.
SCORING SYSTEM:
The treated and the surrounding untreated skin (control area) were examined for erythema/eschar and oedema as well as for other local signs 1, 24, 48 and 72 hours after patch removal.
The skin was examined using a light source KL 1500 electronic.
Dermal irritation was described and recorded according to the scoring scheme of Draize (see in box “Any other information on materials & methods incl. tables”) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All areas treated with the test substance and all control areas were normal before the application.
Erythema/eschar: Not observed at any observation point.
Edema: Not observed at any observation point.
For indi - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not cause any adverse skin reactions in this study.
- Executive summary:
In a primary dermal irritation study conducted according to guideline OECD 404, 3 female New-Zealand-White rabbits were exposed with 0.5 g succinimide in 1 mL deionised water for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. All exposed skin sites were normal at each examination term.
In this study, succinimide is not a dermal irritant.
Reference
Table 1: Individual scoring values
Scores for Animal No.: | |||
1 | 2 | 3 | |
Erythema / Eschar: 1 h/24 h/48 h/72 h | 0/0/0/0 |
0/0/0/0 | 0/0/0/0 |
Edema: 1 h/24 h/48 h/72 h | 0/0/0/0 | 0/0/0/0 | 0/0/0/0 |
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
- Study period:
- 2000-05-01 to 2000-09-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 12 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- OTHER SPECIFICS:
- measurement of pH: 4.4 (1% solution in deionized water, v/v, determined with a pH-Meter) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, D-97633
- Age at study initiation: not specified
- Weight at study initiation: Animal No. 1: 2.4 kg, Animal No. 2: 2.4 kg, Animal No. 3: 2.5 kg
- Housing: Optimal hygienic conditions, individual caging in metal wire cages, Ehret GmbH, type KK016R, 79 cm x 59 cm x 35 cm
- Diet: Altromin 2023 diet for rabbits, ad libitum
- Water: tap water from an automatical watering system, ad libitum
- Acclimation period: 5 days (animal No. 1) and 12 days (animals No. 2 and No. 3)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 20 °C
- Humidity (%): average of 51 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs lightw - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjuctival sacs of the right eyes.
The weighed amounts of the individual doses were 97.89 and 95 mg. - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- Both eyes of the animals were examined within 24 hours before instillation and approximately 1, 24, 48 and 72 hours p.a.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent loss of test substance.
The left eyes remained untreated and served as a control.
Firstly, the test substance was administered to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72-hour observation period (no corrosive effect), the test substance was administered to the other two animals subsequently.
Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a.
Additional examinations were performed 6 days after the instillation.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined using an otoscope lamp. Eye irritation was scored and recorded according to the method of Draize (see in box "Any other information on materials & methods incl. tables") - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All untreated eyes ("control eyes") were normal at any observation time.
Cornea and Iris: Not affected
Conjunctivae, redness: All animals were affected with scores of "1" from 1 h p.a. onwards to 72 h p.a.
Conjunctivae, chemosis: All animals were affected with scores of "1" from 1 h p.a. onwards to a maximum of 24 h p.a.
For individual results see Table 1 in box "Any other information on results incl. tables". - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the test substance succinimide is not irritating to the eyes. All observed effects on conjunctivae redness and chemosis were reversible within 6 days.
- Executive summary:
In a primary eye irritation study conducted according to OECD guideline 405, 0.1 mL of succinimide was instilled into the conjunctival sac of one eye of 3 female New Zealand White rabbits. Animals then were observed of 6 days. Irritation was scored by the method of Draize. Irritant effects on cornea and iris were not observed at any observation point in any animal. Conjunctivae redness is observed in all animals as well as some injected blood vessels were observed from 1 h onwards until 72 h p.a. Very slight swelling was seen in all animals from 1 h onwards until a maximum of 24 h p.a. All effects were fully reversible within 6 days.
In this study, succinimide is not an eye irritant according to CLP criteria.
Reference
Table 1: Individual eye irritation scores
|
|
|
Conjunctivae |
|||||||||
Time after |
Corneae |
Irises |
Redness |
Chemosis |
||||||||
|
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
1 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
1.0 |
1.0 |
1.0 |
0.0 |
0.3 |
0.0 |
6 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study conducted according to guideline OECD 404, 3 female New-Zealand-White rabbits were exposed with 0.5 g succinimide in 1 mL deionised water for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. All exposed skin sites were normal at each examination term. In this study, succinimide is not a dermal irritant.
In a primary eye irritation study conducted according to OECD guideline 405, 0.1 mL of succinimide was instilled into the conjunctival sac of one eye of 3 female New Zealand White rabbits. Animals then were observed of 6 days. Irritation was scored by the method of Draize. Irritant effects on cornea and iris were not observed at any observation point in any animal. Conjunctivae redness is observed in all animals as well as some injected blood vessels were observed from 1 h onwards until 72 h p.a. Very slight swelling was seen in all animals from 1 h onwards until a maximum of 24 h p.a. All effects were fully reversible within 6 days. In this study, succinimide is not an eye irritant according to CLP criteria.
Justification for classification or non-classification
No classification for skin and eye irritation is warranted based on the results from suitable in vivo tests (OECD 404, 405).
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.
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