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EC number: 228-001-3 | CAS number: 6066-82-6
- 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
Carcinogenicity
Administrative data
Description of key information
Supporting study: Painting test. The test item seemed to be non-carcinogenic after dermal application in mice, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
Supporting study: Injection test. The test item seemed to be non-carcinogenic after subcutaneous injection in rats up to 420 mg/animal, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1971
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Method: Mouse Skin-painting test
- Principle of test: To determine potential carcinogenicity of a chemical.
- Short description of test conditions: Repeated applicatoin of a chemical to the sahved skin on the back throughout all or most of the lifespan of the mouse.
- Parameters analysed / observed: Clinical observation of papillomas and carcinomas in the treated area. - GLP compliance:
- no
- Species:
- mouse
- Strain:
- other: SaB
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: 3 months - Route of administration:
- dermal
- Vehicle:
- acetone
- Details on exposure:
- TEST SITE
- Area of exposure: Shaved neck skin
- Time intervals for shavings or clipplings: one week before the star of the experiment
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 drops
- Concentration (if solution): 0.4%
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount(s) applied (volume or weight with unit): 2 drops - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- Twice weekly
- Post exposure period:
- The animals were observed up to 18 months after treatment initiation
- Dose / conc.:
- 0.4 other: %
- Remarks:
- 2 drops of a 0.4% solution
- No. of animals per sex per dose:
- 7 male and 8 female rats
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
DERMAL IRRITATION (if dermal study): No data
BODY WEIGHT: No data
OTHER: Mortality and tumor formation were observed. - Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality related to treament was observed during the test.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No tumors were formed due to treament during the test.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Conclusions:
- The test item seemed to be non-carcinogenic after dermal application in mice, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
- Executive summary:
A skin-painting study of the test item was performed in SaB mice. Fifteen mice, 7 male, and 8 female, were shaved in the neck one week before the start of the experiment. The animals were given twice weekly two drops of a 0.4% solution of test item in acetone up to their natural death. A control group was given acetone in parallel. The animals were observed for 18 months after the experiment initiation. None of the animals showed any tumors during the whole experiment. Under these experimental conditions, the test item seems to be non-carcinogenic, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1971
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Method: Subcutaneous injection test
- Principle of test: To determine potential carcinogenicity of a chemical.
- Short description of test conditions: Administration of a single or repeated dose of a chemical injected subcutaneously into rats.
- Parameters analysed / observed: The development of tumors in the injection site or another part of the body. - GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: 3-4 months - Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 21 weeks
- Frequency of treatment:
- Once weekly
- Post exposure period:
- The animals were observed up to 24 months after treatment initiation
- Dose / conc.:
- 420 other: mg / animal
- No. of animals per sex per dose:
- 7 male and 8 female rats
- Control animals:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
DERMAL IRRITATION (if dermal study): No data
BODY WEIGHT: No data
OTHER: Mortality and tumor formation were observed. - Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality related to treatment was observed during the test.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No tumors were formed due to treatment during the test.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 420 other: mg / animal
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- mortality
- Conclusions:
- The test item seemed to be non-carcinogenic after subcutaneous injection in rats up to 420 mg/animal, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
- Executive summary:
In order to determine the carcinogenic potential of the test item, an injection test was performed in Sprague-Dawley rats. Fifteen rats, 7 male, and 8 female, were given once weekly subcutaneously 2 ml of a physiological saline solution containing 420 mg of test item for a period of 21 weeks. The animals were observed for up to 24 months after the experiment initiation. None of the animals showed any tumors during the whole experiment. Under these experimental conditions, the test item seems to be non-carcinogenic up to 420 mg/animal, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
Referenceopen allclose all
No tumors were observed during the experiment.
Table 1. Carcinogenesis effects of n-hydroxysuccinimide (NHS) after dermal administration in mice.
|
Nº of animals after |
||||
|
0 Months |
6 Months |
12 Months |
18 Months* |
Tumors |
NHS |
15 |
15 |
13 |
5 |
No |
Control |
15 |
15 |
10 |
1 |
No |
NHS: N-hydroxysuccinimide
*After experiment initiation
No tumors were observed during the experiment.
Table 1. Carcinogenesis effects of n-hydroxysuccinimide (NHS) after subcutaneous injection in rats
NHS |
Nº of animals after |
|||||
0 Months |
6 Months |
12 Months |
18 Months |
24 Months* |
Tumors |
|
420 mg |
15 |
15 |
15 |
13 |
9 |
None |
*After experiment initiation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Klimish score 3.
Justification for classification or non-classification
Due to the insufficient data, the test item cannot be classified as carcinogenic according to CLP Regulation (EC) no. 1272/2008.
Additional information
Supporting study: A skin-painting study of the test item was performed in SaB mice. Fifteen mice, 7 male, and 8 female, were shaved in the neck one week before the start of the experiment. The animals were given twice weekly two drops of a 0.4% solution of test item in acetone up to their natural death. A control group was given acetone in parallel. The animals were observed for 18 months after the experiment initiation. None of the animals showed any tumors during the whole experiment. Under these experimental conditions, the test item seems to be non-carcinogenic, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
Supporting study: In order to determine the carcinogenic potential of the test item, an injection test was performed in Sprague-Dawley rats. Fifteen rats, 7 male, and 8 female, were given once weekly subcutaneously 2 ml of a physiological saline solution containing 420 mg of test item for a period of 21 weeks. The animals were observed for up to 24 months after the experiment initiation. None of the animals showed any tumors during the whole experiment. Under these experimental conditions, the test item seems to be non-carcinogenic up to 420 mg/animal, based on the number of tumors. However, no conclusion can be drawn due to the insufficient data.
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