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EC number: 939-682-8 | 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
oral (OECD 401): LD50mouse = 2640 mg/kg bw (neat substance); LD50rat = 3202.5 mg/kg bw (calculated from 3 mL/kg bw with a density of 1.0675 g/cm³)
dermal (OECD 402 limit test): LD50rat > 2000 mg/kg bw (31% a.i.)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Limited documentation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited documentation
- Principles of method if other than guideline:
- Study performed before actual guideline was established.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: range 59 - 86 g
- Fasting period before study: overnight - Route of administration:
- oral: gavage
- Vehicle:
- other: unchanged and water, respectively
- Details on oral exposure:
- - Amount of vehicle (if gavage): 0, 1.6, 2.5, 3.2, 4.0, 5.0, 8.0 ml/kg bw of test substance (aqueous solution)
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw (in the report stated as minimum volume-dosage, which very likely must be a typing error) - Doses:
- 0, 1.6, 2.5, 3.2, 4.0, 5.0, 8.0 ml/kg bw (approximately equivalent to mg/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations several times on the day of application; weighing at dosing and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, time to death, clinical signs, body weight - Statistics:
- From the mortality data the LD50 value and its 95 % confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).
- Preliminary study:
- Range finder with 1 animal per sex and dose at dosages of 0, 5.0 and 10 ml/kg bw indicated a median lethal dose (LD50) in the region of 5 ml/kg bw. Subsequently dosing was extended to groups of 5/sex/dose in order to locate the LD50 more precisely.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 202.5 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 775.5 - 3 629.5
- Remarks on result:
- other: calculated from 3 mL/kg bw based on the density of 1.0675 g/cm³
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 2.6 - 3.4
- Mortality:
- Males:
8.0 ml/kg: 5/5 (after 5 - < 22 h)
5.0 ml/kg: 5/5 (after 5 - < 22 h)
4.0 ml/kg: 5/5 (after < 21 h)
3.2 ml/kg: 2/5 (after < 22 h)
2.5 ml/kg: 0/5
1.6 ml/kg: 0/5
control: 0/5
Females:
8.0 ml/kg: 5/5 (after < 22 h)
5.0 ml/kg: 5/5 (after < 22 h)
4.0 ml/kg: 4/5 (after < 21 h)
3.2 ml/kg: 4/5 (after < 22 - 24 h)
2.5 ml/kg: 2/5 (after < 23 - 27 h)
1.6 ml/kg: 0/5
control: 0/5 - Clinical signs:
- other: Lethargy and diuresis were observed at dosages of 3.2 ml/kg bw or more. Death was preceded by ataxia and coma and usually occurred within 5 to 27 hours following dosing. Recovery of the survivors was apparently complete five days after dosing, as judged
- Gross pathology:
- The deceased animals showed inflammation of the intestines which were devoid of solid content. The autopsies of the survivors revealed no treatment-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment. Only very limited documentation, only 5 days observation period.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Only very limited documentation, only 5 days observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 18 - 21 g
- Fasting period before study: no data
- Housing: 5/cage
- Diet (e.g. ad libitum): Lab Blox, ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 % (test material was diluted 1:3 in water just prior to the test) - Doses:
- 6670, 8350, 10000 mg/kg bw
- No. of animals per sex per dose:
- 10 (sex not specified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Necropsy of survivors performed: no data - Statistics:
- Oral LD50 was calculated according to the method of Litchfield and Wilcoxon (1949).
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 640 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 2 310 - 3 000
- Remarks on result:
- other: recalculated to neat substance
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 8 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 7 700 - 10 000
- Mortality:
- 10000 mg/kg: 7/10
8350 mg/kg: 4/10
6670 mg/kg: 1/10 - Clinical signs:
- other: not reported
- Gross pathology:
- not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment Only one animal/dose
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- insufficient documentation, only one animal/dose
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Chr-CD
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: aqueous solution of 60% of original substance (25% active ingredient as sodium salt in aqueous solution) for 3400, 5000, 7500, 11000 and 17000mg/kg bw and 20 % of original substance (25% active ingredient as sodium salt in aqueous solution) for 670 and 2250mg/kg bw
- Amount of vehicle (if gavage): no data - Doses:
- 670, 2250, 3400, 5000, 7500, 11000, 17000 mg/kg bw
- No. of animals per sex per dose:
- 1
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Sex:
- male
- Dose descriptor:
- other: approx. LD100
- Effect level:
- 7 500 mg/kg bw
- Mortality:
- Animals that received 17000, 11000 and 7500 mg/kg bw died within 2 days, lower dosed animals survived to the end of the observation period
- Clinical signs:
- other: At lethal doses: severe weight loss, diarrhea, bloody discharge from nose and mouth at death; at non-lethal doses: weight loss, diarrhea and increased water intake
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- mouse
- Effect level:
- 2 640 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 2 310 - < 3 000
- Remarks on result:
- other: recalculated to neat substance. CAS 68424-94-2
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- mouse
- Effect level:
- 8 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 7 700 - <= 10 000
- Remarks on result:
- other: CAS 68424-94-2
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- 3 202.5 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 775.5 - <= 3 629.5
- Remarks on result:
- other: calculated from 3 mL/kg bw based on the density of 1.0675 g/cm³. CAS 931-700-2
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- 3 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.6 - <= 3.4
- Remarks on result:
- other: CAS 931-700-2
- Sex:
- male
- Dose descriptor:
- LD100
- Remarks:
- rat
- Effect level:
- ca. 7 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CAS 683-10-3
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- 71 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 52 - 96
- Remarks on result:
- other: CAS 683-10-3
- Remarks:
- disregarded study
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Remarks:
- rat
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CAS 683-10-3
- Remarks:
- disregarded study
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for Betaines, C12-14 (even numbered)-alkyldimethyl, potassium salt; aqueous commercial product(s) is estimated to be 2640 mg/kg bw.
- Executive summary:
Several studies are available from structural analogues CAS 68424 -94 -2, EC 931 -700 -2 and 683 -10 -3. The LD50 for Betaines, C12-14 (even numbered)-alkyldimethyl, potassium salt; aqueous commercial product(s) was estimated to be 2640 mg/kg bw from the most sensitive study. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the oral LD50 that are higher than the typical experimental error of the test method.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original reference not available.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Kashima Laboratory, Mitsubishi Chemical Safety Institue Ltd., 14 Sunayama, Kamisu-shi, Ibaraki, 314-0255, Japan
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nihon Charles River
- Age at study initiation: 8 weeks
- Weight at study initiation: 182-203 g ± 20%
- Fasting period before study: 18 hours before and 3 hours after
- Housing: polycarbonate cages (265W x 426D x 200H mm)
- Diet (ad libitum): MF Oriental
- Water (ad libitum): filtered (5 μm) and ultra-violet radiated
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 - 22.8
- Humidity (%): 43.1 - 69.3
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12 (7.00 - 19.00 light on)
- Route of administration:
- oral: gavage
- Vehicle:
- other: water for injection
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL and 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: Material Safety Data Sheet and RTECS (Registry of Toxic Effects of Chemical Substances) - Doses:
- 300 mg/kg (1st and 2nd steps) and 2000 mg/kg (3rd step)
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily; weighing on days 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, body weight gain - Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 300 - 2 000 mg/kg bw
- Mortality:
- All animals receiving 2000 mg/kg died within 2 days of the administration. No mortality was observed in the 300 mg/kg group.
- Clinical signs:
- other: Clinical signs appeared approximately 30 minutes after application of the test substance. Decrease in locomotor activity, irregular respiration, loose stool, and soiled perineal regions were noted before death. No clinical signs were observed in the 300 m
- Gross pathology:
- At necropsy, distention of the stomach or small intestine, reddening of the glandular stomach epithelium, abnormal contents of the small intestine, hemorrhage in the thoracic cavity, and red ascites in the abdominal cavity were noted in dead animals.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: acute oral 4, H302
DSD: Xn, R22 - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment. Dose levels not specified.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- dose levels not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 200 - 250 g
- Fasting period before study: yes, overnight
- Acclimation period: 5 days - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 % (w/v) - Doses:
- 4 dose levels, not further specified
- No. of animals per sex per dose:
- 5 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 values were calculated using the moving average method (Thompson, 1947). Comparison between datasets, where appropriate, used Student's t test.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 71 mg/kg bw
- 95% CL:
- 52 - 96
- Clinical signs:
- other: sluggishness, diarrhea, and lacrimation in some animals
- Gross pathology:
- Deceased animals showed distension of the gastrointestinal tract with red fluid, the lungs appeared mottled and red.
Referenceopen allclose all
Conclusion:
The findings in the deceased animals demonstrate mortality due to local irritant effects in form of gastro-intestinal inflammation rather than systemic toxicity. According to the criteria of the DSD and the CLP regulation the substance does not have to be classified for acute oral toxicity.
The approx. LD100 for N-Lauryl Betaine as a solution of the sodium salt was 7500 mg/kg bw in male rats.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 640 mg/kg bw
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2-4) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on structural and physico-chemical similarities (refer to endpoint discussion for further details). Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
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
- Adequacy of study:
- key study
- Study period:
- 1987-07-27 to 1987-08-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD (Crl:COBS CD(SD)BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 200 to 232 g
- Fasting period before study: no
- Housing: individually housing in metal cages with wire mesh floors
- Diet: ad libitum, standard laboratory rodent diet "Labsure LAD 1"
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- One day prior to treatment hair was removed from the dorsolumbar region of each rat with electric clippers exposing an area equivalent to 10% of the total body surface. No shaving or chemical depilation was used.
The test substance was applied by spreading it evenly over the prepared skin. Total volume applied was 1.92 ml/kg bw. Test substance was applied in the original state (aqueous solution, a.i. 31 %) as delivered by the sponsor. The treated area was then promptly covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.
At the end of the 24-hours exposure period, the dressings were carefully removed and the treated area of skin decontaminated by washing in warm (30°-40°C) water and blotting dry with absorbent paper. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (based on product),
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Body weights were recorded on Day 1 (day of dosing), 8 and 15
- Clinical observation: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturday and Sunday. Clinical signs were recorded at each observation. The nature, severity, approximate time of
onset and duration of each toxic sign.
- Necropsy of the survivors performed: yes
- Other examinations performed: skin reactions - The treated areas of skin were examined daily for signs of dermal irritation and assessed according to the following arbitrary scoring system.
Erythema and eschar formation:
No erythema = score 0
Slight erythema = score 1
Well-defined erythema = score 2
Moderate to severe erythema = score 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = score 4
Oedema formation:
No oedema = score 0
Slight oedema = score 1
Well-defined oedema (area well-defined by definite raising) = score 2
Moderate oedema (raised approximately 1 millimetre) = score 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) = score 4
A separate record was kept of dermal changes other than erythema and oedema. - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: based on product
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 620 mg/kg bw
- Remarks on result:
- other: based on a.i.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: based on product; mortality 0/10
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 620 mg/kg bw
- Remarks on result:
- other: based on a.i.; mortality 0/10
- Mortality:
- 0/10
- Clinical signs:
- other: - Application site: Sites of application of the test substance showed slight or well-defined erythema in all animals on Day 2 and/or 3. On Day 4 and Day 5, slight erythema were seen in three male and four female rats, sloughing in two male rats and one fe
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
In an acute dermal toxicity study according to EU Method B.3 and OECD Guideline 402, 5 male and 5 female CD rats (Crl:COBS CD(SD)BR) were dermally exposed to Coco AAPB (a.i 31 %) as delivered by the sponsor for 24 hours to 10% of total body surface at a dose of 2000 mg/kg bw (limit test). Test sites were covered with an occlusive dressing. After 24 hours, the test sites were rinsed with warm water. Animals then were observed for 14 days after dosing.
There were no clinical signs of systemic reaction to treatment. Sites of application of the test substance showed slight or well-defined erythema in all animals on Day 2 and/or 3. On Day 4 and Day 5, slight erythema were seen in three male and four female rats, sloughing in two male rats and one female rat and hyperkeratinisation in three female rats. All skin reactions were completely reversible by Day 6 in all animals. Slightly low bodyweight gains were recorded for three females on Day 8. All other rats achieved anticipated bodyweight gains throughout the study. Terminal autopsy findings were normal.
Dermal LD0 Combined: 2000 mg/kg bw
Dermal LD50 Combined: > 2000 mg/kg bw
LD0 and LD50 determined refer to the test substance as delivered by the sponsor. Amount of active ingredient in test substance is 31 %. Therefore the calculated oral LD0and LD50 combined referring to 100 % active substance is 620 and > 620 mg/kg bw, respectively.
Coco AAPB (a.i. 31 %) is of low toxicity based on the LD50 in males and females.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: based on product
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 620 mg/kg bw
- Remarks on result:
- other: based on a.i.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: based on product; mortality 0/10
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 620 mg/kg bw
- Remarks on result:
- other: based on a.i.; mortality 0/10
- Mortality:
- 0/10
- Clinical signs:
- other: - Application site: Sites of application of the test substance showed slight or well-defined erythema in all animals on Day 2 and/or 3. On Day 4 and Day 5, slight erythema were seen in three male and four female rats, sloughing in two male rats and one fe
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An dermal LD50 greater than 2000 mg/kg bw was estimated for Betaines, C12-14 (even numbered)-alkyldimethyl, potassium salt; aqueous commercial product(s).
- Executive summary:
One study is available from the structural analogue CAS 61789 -40 -0. The LD50 for Betaines, C12-14 (even numbered)-alkyldimethyl, potassium salt; aqueous commercial product(s) was estimated to be greater than 2000 mg/kg bw from this study. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the oral LD50 that are higher than the typical experimental error of the test method.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on structural and physico-chemical similarities (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
There is no data available on the acute toxicity of N,N-dimethyl-alkyl-1-amines, reaction products with alkali hydroxide and chloroacetic acid. However, there is reliable data for the structural related substances CAS 68424-94-2, CAS 683-10-3, EC 931-700-2 and CAS 61789-40-0. The target substance and the source substances show pronounced structural and physico-chemical similarities. Therefore, read-across was performed based on an analogue approach. For a detailed justification of the analogue approach, please refer to section 13 of the technical dossier.
Two reliable studies are available addressing acute oral toxicity, the first one performed with undiluted EC 931-700-2 in rats (Huntingdon Research Centre, 1969) and the second one with an undiluted aqueous solution containing 30% a.i. of CAS 68424-94-2 in mice (Levenstein, 1979). The most sensitive one was the study with CAS 68424-94-2, demonstrating an LD50 of 2640 mg/kg bw, recalculated to neat substance, in mice. With EC 931-700-2 a LD50 of 3202.5 mg/kg bw was demonstrated in rats. The mortality observed in this study had to be attributed to local irritant effects of the test substance, manifesting in form of gastro-intestinal inflammation in the deceased animals only, rather than systemic toxicity. Both values were in the same range of magnitude. Therefore, 2640 mg/kg bw was adopted as oral LD50 as the most sensitive value. The values are also in line with an approximate LD100 of 7500 mg/kg bw reported for CAS 683-10-3 by the supporting study (Haskell Laboratory, 1963). Further information for that substance is available from a secondary source reporting a result derived from the acute toxic class method (Kashima Laboratory, 2005). In this study a classification into acute toxicity class 4 (LD50 >300 - 2000 mg/kg bw) was derived. The original data source was not available, therefore it was not chosen for assessment. Additionally, an LD50 of 71 mg/kg bw is reported in a publication (Ridout et al., 1991). Although being the lowest value in the range this publication was not chosen for assessment. First of all it suffers from extremely limited documentation, as even dose levels were not reported, and secondly the value is extraordinarily low in comparison with any other available data, which lacks a logical explanation. Therefore, this publication was not suitable for assessment.
For acute dermal toxicity, read-across data from cocamidopropyl betaine (CAS 61789-40-0) is used (Kao, 1987). This study was designed as a limit test with application of 2000 mg/kg bw of an aqueous solution with 31% active ingredient (commercial product, as supplied) to the skin of rats for a period of 24 hours under occlusive conditions. No mortality occurred, and no clinical signs were observed within the 14-day observation period. There were no unusual findings at terminal autopsy; the only observations were signs of slight to well-defined local skin irritation at the application sites. Therefore, an LD50 > 2000 mg/kg bw was established for the commercial product with 31% active ingredient, the dermal LD50 for 100% active substance was calculated to be > 620 mg/kg bw.
However, although the read-across study conducted with CAS 61789-40-0 does not cover the limit dose requested by OECD guideline 402, carrying out additional acute dermal studies for the pure substances is scientifically not justified as the test substance is assumed to be corrosive at concentrations greater than 30% based on experimental data and on a worst case assumption.
Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read across from
structural analogues. All available studies are adequate and reliable
based on the identified similarities in structure and intrinsic
properties between source and target substances and overall quality
assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across from a
structural analogue. The selected study is the most adequate and
reliable study based on the identified similarities in structure and
intrinsic properties between source and target substance and overall
quality assessment (refer to the endpoint discussion for further
details).
Justification for classification or non-classification
The available data on acute oral and dermal toxicity of the analogue substances do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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