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EC number: 944-951-8 | 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Key information is based on weight of evidence data from a developmental toxicity study performed with diisopropanolamine, an analogue of one of the main components, aminopropanol.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study is performed with diisopropanolamine (DIPA) as analogue for aminopropanol with the amine as common functional group. Similar breakdown products are expected involving various processes including oxidation and conjugation. DIPA, as amino- propanol, is used as water-soluble emulsifier and neutralizer in cosmetic products at concentrations up to 1%. As reviewed by CIR, DIPA is of low acute systemic toxicity, with an oral LD50 of 4765 mg/kg to rats and a dermal LD50 of >1000 mg/kg for rabbits, but, like 3-amino-propanol, it is irritating to both skin and eye (Cosmetics Ingredient Review, 1987. Final report on the safety assessment of diisopropanolamine, triisopropanolamine, isopropanolamine, and mixed isopropanolamine. J. Am. Coll. Toxicol. 6, 53–76).
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Testing laboratory: The Dow Chemical Company, 1803 Building, Midland, MI 48674, United States
- Specific details on test material used for the study:
- Source: obtained from The Dow Chemical Company (Midland, MI).
Puritie: 98.8% to 99.6% - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Time-mated female CRL:CD(SD) rats were obtained from Charles River Laboratories Inc. (Portage, MI).
- Age at study initiation: adults
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet: ad libitum LabDiet#5002 Certified Rodent Diet (PMI Nutrition International, St. Louis, MO)
- Water: ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21–25
- Humidity (%): 45–60%
- Air changes (per hr): 12–15 room air changes/h
- Photoperiod (hrs dark / hrs light): 12 h photocycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Groups of 25 time-mated female Sprague–Dawley rats were given 0, 100, 300, or 1000 mg DIPA/kg/day on gestation days 6 through 20 by oral gavage.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of DIPA in all dose solutions ranged from 95% to 105% of target.
- Details on mating procedure:
- time-mated females
- Duration of treatment / exposure:
- gestation days 6 through 20
- Frequency of treatment:
- daily
- Duration of test:
- 21 days
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: dose levels were determined from a probe toxicity study in which 1000 mg/kg/day given to pregnant rats did not cause maternal toxicity or embryotoxicity
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED OBSERVATIONS/EXAMINATIONS: Yes
- Time schedule: weekly, detailed (handheld) clinical examinations, body weight, weight gain, and feed consumption
- On gestation day 21, all rats were euthanized, examined grossly, and the weights of the liver, kidneys and gravid uterus were collected. The number of corpora lutea, uterine implantations, resorptions and live/dead fetuses were determined.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY & CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Ovaries and uterine content:
- on day 21 of gestation by CO2 inhalation and gross pathologic examination was conducted.
The weights of the kidneys, liver and gravid uteri were obtained and the kidneys, liver and all gross lesions were preserved in 10%NBF.
A detailed examination of the reproductive tract was conducted which included the number and position of all implants, viable fetuses, dead fetuses, resorptions, and the number of ovarian corpora lutea. Uteri lacking visible implantations were stained with a 10% aqueous solution of sodium sulfide for evidence of early resorptions. - Fetal examinations:
- - Sex ratio and body weight
- External examinations: Yes, all per litter
- Soft tissue examinations: Yes, one-half of the fetuses from each litter were randomly selected for a visceral examination, conducted by dissection under a low power stereomicroscope
- Skeletal examinations: Yes, Fetuses not selected for visceral examination were skinned, eviscerated, preserved in alcohol, double stained with Alcian Blue and Alizarin Red S, cleared and evaluated for skeletal changes
- Head examinations: Yes, heads of the fetuses used in soft tissue examination were placed in Bouin’s fixative and subsequently serially sectioned for examination of the eyes, brain, nasal passages and tongue - Statistics:
- - Maternal body weight, weight gain, feed consumption, organ weights and fetal body weights: Parametric or non-parametric ANOVA, followed by Dunnett’s or Wilcoxon’s test for comparison to controls
- Pre- and post-implantation loss: Censored Wilcoxon’s test Haseman and Hoel
- Corpora lutea, implantations and litter size: Non-parametric ANOVA followed by Wilcoxon’s test
- Pregnancy rates: Fisher exact probability test
- Fetal sex ratios: Binomial distribution test - Indices:
- Not specified
- Historical control data:
- Not specified
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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 examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical signs
- dead fetuses
- dermal irritation
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- mortality
- necropsy findings
- number of abortions
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- A statistically identified shift in sex ratio vs. binomial distribution of the control pups, but this was considered as not toxicologically significant.
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- The small number of alterations observed in fetuses from dams given DIPA either occurred at low frequencies and/or not in a dose-related manner.
- Visceral malformations:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- The present oral development toxicity study with diisopropanolamine in rats resulted in no observed adverse effect levels (NOAEL) >1000 mg/kg/day for both maternal and fetal effects.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Secondary litterature but described in sufficient detail in a recognised International Organisation report. Acceptable for assessment.
D-gluconate is one of the main constituents of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide at a molar ratio of 1:1. The process used is a pseudo acid – base reaction in water that leads always to a mixture of the “amide” and the “salt” part. Both entities are required for the applications performances. With the manufacturing process used here it is not possible to separate the amide and salt part from the water phase. D-gluconate is the anion of the salt part. - Principles of method if other than guideline:
- SIDS testing requirements regarding reproductive toxicity were satisfied with histopathology of the reproductive organs in repeat dose studies on sodium gluconate and with developmental toxicity studies on glucono-delta-lactone.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Not specified.
- Species:
- mouse
- Strain:
- ICR
- Details on test animals or test system and environmental conditions:
- Not specified.
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- Exposure period: from day 6 to day 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 10 days
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Not specified.
- Details on study design:
- GDL was administered orally to female nulliparous mice for 10 days and the fetuses were observed by laparotomy on dams on pregnancy day 18. Several dams in each group wereallowed to deliver spontaneously, and the offspring wereobserved until
postnatal day 21. - Maternal examinations:
- general condition, body weight change and food consumption
- Ovaries and uterine content:
- number of implantations and dead fetuses
- Fetal examinations:
- Survival, external, visceral and skeletal examinations.
- Statistics:
- Not specified.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- >= 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in pregnancy duration
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- mortality
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- visceral malformations
- Developmental effects observed:
- no
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Secondary litterature but described in sufficient detail in a recognised International Organisation report. Acceptable for assessment.
D-gluconate is one of the main constituents of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide at a molar ratio of 1:1. The process used is a pseudo acid – base reaction in water that leads always to a mixture of the “amide” and the “salt” part. Both entities are required for the applications performances. With the manufacturing process used here it is not possible to separate the amide and salt part from the water phase. D-gluconate is the anion of the salt part. - Principles of method if other than guideline:
- SIDS testing requirements regarding reproductive toxicity were satisfied with histopathology of the reproductive organs in repeat dose studies on sodium gluconate and with developmental toxicity studies on glucono-delta-lactone.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Not specified.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- No details
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- Exposure period: from day 6 to day 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 10 days
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Not specified
- Details on study design:
- GDL was administered orally to female nulliparous rats for 10 days and the fetuses were observed by laparotomy on pregnancy day 21. Several dams in each group were allowed to deliver spontaneously, and the offspring were observed until postnatal day 21.
- Maternal examinations:
- general condition, body weight change or food consumption
- Ovaries and uterine content:
- number of implantations/dead fetuses
- Fetal examinations:
- Survival, mean body weight, external appearance, visceral and skeleton examination.
- Statistics:
- Not specified.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Observation of the dams allowed to deliver spontaneously, protraction of the duration of pregnancy or abnormalities at birth were not observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- mortality
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 4 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- visceral malformations
- Developmental effects observed:
- no
Referenceopen allclose all
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- other: rat and mouse
- Quality of whole database:
- Studies included a guideline study and two studies referred to in SIDS Initial Assessment Report for SIAM 18.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
SIDS testing requirements regarding reproductive toxicity were satisfied with histopathology of the reproductive organs in repeat dose studies on sodium gluconate and with developmental toxicity studies on glucono-deltalactone. Indeed no changes were observed on the reproductive organs in 28 days oral studies with sodium gluconate (dosage up to 4400 mg/kg bw) and developmental toxicity studies on glucono-deltalactone on different species were all negative. An oral development toxicity study with diisopropanolamine in rats resulted in no observed adverse effect levels (NOAEL) >1000 mg/kg/day for both maternal and fetal effects.
Justification for classification or non-classification
Based on weighed evidence from various developmental toxicity and repeated dose studies, there is no indication that Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide meets the criteria for classification as toxic for reproduction.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.