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EC number: 204-878-8 | CAS number: 128-09-6
- 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
The substance is hazardous with oral LD50-values reported in the range of 1000 to 2700 mg/kg bw. After intravenous application the LD50 is between 200 and 400 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June 1995 to 19 October 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.1. "Acute Toxicity-Oral", July 31, 1992.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.; Wölferstrasse 4, 4414 Füllingsdorf/Switzerland
- Age at study initiation: male: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 200.9 - 221.6 g; females: 179.8 - 196.6 g
- Fasting period before study: approximately 16h
- Housing: Makrolon type 4 with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pellet standard Kliba 343, Batch no. 86/95 rat maintainance diet, ad libitum
- Water: Tap water from Füllingsdorf, ad libitum
- Acclimation period: One week under laboratory condtions, after health examination. Only animals without any visible signs of illnes were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24°C
- Humidity (%): 48 to 90 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 artificial fluorescent light (approx. 100 Lux) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (bi-distilled)
- Details on oral exposure:
- The test article was placed into a glas beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra Turax, Janke & Kunkel, D-79219 Staufen). Homogeneity of the test article was maintained during treatment using a magnetic stirrer (Janke & Kinkel, D.-79219 Staufen). The preparation was made shortly before dosing. The animals received a single dose of the test article on a mg/kg bw basis by oral gavage following fasting for approx. 16 hours, but with free access to water. Food was provided again approx. 3 hours after dosing.
Application Volume: 10 ml/kg - Doses:
- 500 mg/kg bw (Group 1)
1000 mg/kg bw (Group 2)
2000 mg/kg bw (Group 3) - No. of animals per sex per dose:
- 5 males and 5 females: 500 mg/kg bw (Group 1)
5 males and 5 females: 1000 mg/kg bw (Group 2)
5 males and 5 females: 2000 mg/kg bw (Group 3) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: each animal was examined for changes in apperance and behaviour four to five times during day 1 and once daily for surviving animals during days 2-15. weighing: day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights - Statistics:
- The LOGIT-Model (COX, Analysis of Binary Data, London 1977) was used to calculate the mean lethal dose. The 90%, 95% and 99% confidence limits for the toxicity value and the slope of the dos response line were calculated.
- Preliminary study:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 212 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 927 - 1 704
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 529 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 959 - 6 036
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 952 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 574 - 1 451
- Mortality:
- The following mortality was observed:
500 mg/kg bw (Group 1): males: 0%, females: 0%
1000 mg/kg bw (Group 2): males: 0%, females: 60%
2000 mg/kg bw (Group 3): males: 80%, females: 100%
For further details please see also the attached background material: Pfister.1995.Acute oral toxicity study with N-chlorosuccinimide in rats_ tabels and appendices.pdf - Clinical signs:
- other: The following clinical signs were observed during the observation period: 500 mg/kg bw (Group 1): sedation (5/5)*, ruffled fur (3/5) 1000 mg/kg bw (Group 2): sedation (5/5), ruffled fur (3/5), emaciation (1/3), lacrimation (0/2) 2000 mg/kg bw (Group 3):
- Gross pathology:
- The following macroscopic organ findings were observed at necropsy:
500 mg/kg bw (Group 1): scheduled necropsy - no findings
1000 mg/kg bw (Group 2): scheduled necropsy - one male presented stomache distended with gas; spontaneous deaths - one female presented stomache distended with gas and black-brown contents in jejunum
2000 mg/kg bw (Group 3): scheduled necropsy - one male presented distended stomache; spontaneous deaths - one male and two females contained reddish fluid in body cavities, one male presented distended stomache
For further details please see also the attached background material: Pfister.1995.Acute oral toxicity study with N-chlorosuccinimide in rats_ tabels and appendices.pdf - Other findings:
- For further details please see also the attached background material: Pfister.1995.Acute oral toxicity study with N-chlorosuccinimide in rats_ tabels and appendices.pdf
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 of N-chlorosuccinide is 1212 mg/kg bw in rats.
- Executive summary:
N-chlorosuccinimide was administered to three groups of 5 male and f 5 male and 5 female rats by oral gavage at single doses of 500, 1000 and 2000 mg/kg bw.
The following mortality was observed:
500 mg/kg bw (Group 1): males: 0%, females: 0%
1000 mg/kg bw (Group 2): males: 0%, females: 60%
2000 mg/kg bw (Group 3): males: 80%, females: 100%Based on these observations, the LD50 estimation for acute oral toxicity in rats of both sexes, observed over a period of 14 days is 1212 mg/kg bw.
Reference
For further details please see also the attached background material: Pfister.1995.Acute oral toxicity study with N-chlorosuccinimide in rats_ tabels and appendices.pdf
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 212 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The newer guideline study of Pfister 1995 was selected as the key study.
Justification for classification or non-classification
Three acute oral and one acute intravenous results are availbale for N-chlorosuccinimide:
- According to Pfister (Key, 1995) the oral LD50 to rats is 1212 mg/kg bw.
- According to Stohlman (Supporting, 1944) the LD50 after oral application to rats is between 1000 and 2700 mg/kg bw, and after intravenous application the LD50 is between 200 and 400 mg/kg bw.
Both acute oral values are within the same range. The Key study (Pfister, 1995) is deemed as most reliable as this study is the most recent one, conducted according to GLP and the study report is fully available. Therefore the oral LD50 of N-chlorosuccinimide is set to 1212 mg/kg bw.
The results of the available acute toxicity studies indicate a classification of N-chlorosuccinimide according to DSD and CLP as follows:
CLP: Acute Toxicity Category 4
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