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EC number: 827-581-0 | CAS number: -
- 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
In an klimsch score 2 study on DEFI an LD50 (oral) of >5000 mg/kg/bw was achieved
In an klimsch score 2 study on SLI an
LD50 (dermal) of >2000 mg/kg/bw was achieved
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
- Remarks:
- Read-across to DEFI
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is a one page report with limited details provided. However, the results serve to indicate the low toxicity of the test substance.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Guideline:
- other: In house method G.2.2.1.
- Principles of method if other than guideline:
- 5 groups of male Sprague Dawley rats were given a single dose of DEFI (20% concentration) on day 1 doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg. Animals were observed for mortality and clinical signs on days 1, 2, 3, 4, 7 and 14, with bodyweight measured on days 0, 7 and 14.
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 170-201g - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: not reported - Doses:
- Single doses of 3.3, 4.1, 5.1, 6.4 and 8.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and other overt signs on days 1, 2, 3, 4, 7, and 14. Body weights were measured on days 0, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- Probit (E1-2)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 8 400 mg/kg bw
- Mortality:
- Mortalities were observed in the two highest dose groups only. In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2. In the 6.4 g/kg group one animal died on day 4.
- Clinical signs:
- Slight diarrhea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing. Moderate diarrhea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Lethargy was observed in all 8.0 g/kg dose animals 1 hour after dosing. Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 doses
- Body weight:
- No significant effects to body weight were observed.
- Gross pathology:
- Gross pathology at necropsy revealed no significant findings.
Moderate inflammation of the gastric mucosa was observed in the animals that died on day 1 and 2 in the 8.0 g/kg bw dose. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study performed similar to current guidelines DEFI is considered to be of low toxicity, with a LD50 of 8.4 g/kg.
Reference
Mortalities were observed in the two highest dose groups only. In the 8 g/kg group, 2 animals died on day 1 and 1 on day 2. In the 6.4 mg/kg group one animal died on day 4.
Clinical signs were observed in all dose groups except the lowest (3.1 g/kg).
Lethargy was observed in all 8 mg/kg dose group animals approximately 1 hour after dosing. Some lethargy was also observed at about 22 hours in a single animal each at the 6.4 and 8.0 g/kg doses.
Diarrhoea was observed in the 4.1, 5.1, 6.4 and 8 g/kg dose groups. Moderate diarrhoea was observed in two, four and five animals about 1 hour after dosing in the 5.1, 6.4, and 8.0 g/kg bw doses, respectively. Slight diarrhoea was observed in two animals in the 4.1 g/kg dose within 1-2 hours after dosing.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Good, two klimisch score 2 studies and a peer reviewed, review article provide the data
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Remarks:
- Read-across to SCI
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study based on OECD guideline 410. Read across from SCI to SCMI
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- No ophthalmological observations were performed.
- Principles of method if other than guideline:
- This repeat dose study up to a limit dose of 2 g/kg bw is considered suitable to estimate the acute dermal LD50.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other:
- Species:
- rat
- Strain:
- other: Charles River COBS CDR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, MI, U.S.
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 176-200g - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Clipped dorsal area, 32 cm2 for body weights below 350 g, 36 cm2 for body weights of 350 to 400 g and 40 cm2 for body weights of 400 g
- Type of wrap if used: Gauze
- Time intervals for shavings or clipplings:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.08 g a.i./kg (1.0% w/w), 0.91 g a.i./kg (14.0% w/w) and 2.07 g a.i./kg (36.0% w/w)
VEHICLE
- Millipore filtered water - Duration of exposure:
- 6 h per day for 28 days
- Doses:
- 0.08 g a.i./kg (1.0% w/w), 0.91 g a.i./kg (14.0% w/w) and 2.07 g a.i./kg (36.0% w/w) nominal per unit body weight
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: LOAEL 2.07 g/kg
- Mortality:
- No treatment related effects. One male rat in the vehicle control group and one male rat in the 14.0% (w/w) group died during the study but these deaths were attributed to mechanical trauma due to struggling during the gauze wrapping procedure.
- Clinical signs:
- Very slight erythema (+1) was observed in two males during weeks 3 and 4. Dermal irritation in females was observed in each treatment group during week 1 of the study. Very slight erythema was observed in four females in the 1.0% (w/w) and 14.0% (w/w) treatment groups during the first week but no irritation was observed during the remainder of the study. Females in the 36.0% (w/w) group showed very slight and well-defined erythema (+2) which showed a significant difference from the control on days 4, 5, 6 and 7 of the study only Very slight oedema (+1) was also observed in females in this group but the difference was not significant.
- Body weight:
- No significant difference between any group means during the test. Individual body weight data showed transient low weight gains and losses for males and females in all test groups, including the control.
- Gross pathology:
- Necropsy revealed red patchy areas on the lungs of rats occurring randomly throughout the control and test groups, with one rat showing pale lungs in the 1.0% (w/w) test group. None of these findings were considered to be treatment related.
Histopathology results showed no treatment related effects as all findings were considered to be incidental, except microscopic findings in the liver of one male in the 36.0% (w/w) treatment which showed fibrous trabeculae, increased Kupffer cell macrophages and lipofuscin pigment and one female in the vehicle control which showed coagulative necrosis of one liver lobe. These findings were determined to be due to mechanical trauma.
Excised skin sections showed slight microscopic differences in morphology between treated and untreated sites in each of the control and test groups. Skin from the treated sites showed a slight thickening of the epithelium and slightly increased cornification. The basal cell layer showed a slight increase in the mitotic rate in the treated skin sites compared to the untreated sites. These differences were attributed to the vehicle and semi-occlusive gauze dressing since there were no difference between the vehicle control and SCI treated groups. In addition, no inflammatory changes were observed. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a study performed to OECD 410, there was no evidence of systemic toxicity in the treated animals during the study up to the highest dose of 2.07 g/kg/day. Observations revealed very slight erythema in a few males at the highest dose and slight erythema and oedema in females at the highest dose. Both findings decreased in incidence and severity towards the end of the study. There was no evidence of skin irritation on day 1 of the study and thus the NOAEL for acute local effects is 2.07 g/kg bw.
Reference
Necropsy revealed red patchy areas on the lungs of rats occurring randomly throughout the control and test groups, with one rat showing pale lungs in the 1.0% (w/w) test group. None of these findings were considered to be treatment related. Histopathology results showed no treatment related effects as all findings were considered to be incidental, except microscopic findings in the liver of one male in the 36.0% (w/w) treatment which showed fibrous trabeculae, increased Kupffer cell macrophages and lipofuscin pigment and one female in the vehicle control which showed coagulative necrosis of one liver lobe. These findings were determined to be due to mechanical trauma. Excised skin sections showed slight microscopic differences in morphology between treated and untreated sites in each of the control and test groups. Skin from the treated sites showed a slight thickening of the epithelium and slightly increased cornification. The basal cell layer showed a slight increase in the mitotic rate in the treated skin sites compared to the untreated sites. These differences were attributed to the vehicle and semi-occlusive gauze dressing since there were no difference between the vehicle control and SCI treated groups. In addition, no inflammatory changes were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good quality study
Additional information
Three acute oral toxicity studies are available for read-across analogues of SCMI.
One key study and two supporting studies:
(Unilever, 1982) found in an study performed similar to current guidelines the read across material Sodium Cocoyl Isethionate is considered to be of low toxicity, with a LD50 of 8.4 g/kg.
Two supporting studies support the lack of acute oral toxicity for the read across SCI.
Unilever, (1991) obtained a dermal LD50 in excess of 2000 mg/kg.
Justification for selection of acute toxicity – oral endpoint
Reliable study on read across substance sodium cocoyl isethionate
Justification for selection of acute toxicity – dermal endpoint
data is from OECD 410 study but the findings are relevant.
Justification for classification or non-classification
Acute oral and dermal LD50 values for the read across substances SCI and SLI were in excess of 2000mg/kg bw.
Therefore SCMI has not been classified as acutely toxic for any exposure.
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