Registration Dossier
Registration Dossier
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EC number: 251-974-0 | CAS number: 34375-28-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL value was considered to be 250 mg/kg bw per day and LOAEL value was considered to be 500 mg/kg bw per day in female Sprague-Dawley rat when exposed to 2-[hydroxy(methyl)amino]ethanol.
Link to relevant study records
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from review article or handbook
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline 83-3(a)
- Principles of method if other than guideline:
- Evaluation of reproductive toxicity of Ethanol, 2-(hydroxymethylamino) in Sprague-Dawley rat.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ethanol, 2-(hydroxymethylamino)
- Molecular formula (if other than submission substance): C3H9NO2
- Molecular weight (if other than submission substance): 91.1091 g/mole
- Substance type: Organic - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data avaialble
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- -Age at study initiation: Approximately 9 weeks
- Diet (e.g. ad libitum):Food ad libitum
- Water (e.g. ad libitum):water ad libitum - Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:The test chemical was dissolved in distilled water to give a dose range of 0, 100, 250 and 500 mg/kg/day
VEHICLE
- Justification for use and choice of vehicle (if other than water):Distilled water
- Concentration in vehicle:0, 100, 250 and 500 mg/kg/day - Details on mating procedure:
- - M/F ratio per cage: 2 females to each male
- Length of cohabitation: cohabitation with a male was continuous until mating was detected
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy A vaginal lavage was examined each morning and the day of detection of sperm in the lavage, or of a copulatory plug in situ, was considered as Day 0 of gestation.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 days after gestation.
Exposure Period: 6 - 16 days, inclusive of gestation - Frequency of treatment:
- Once daily
- Details on study schedule:
- no data available
- Remarks:
- 0, 100, 250 and 500 mg/kg/day
- No. of animals per sex per dose:
- Total:100
0 mg/kg bw : 25 female
100 mg/kg bw : 25 female
250 mg/kg bw : 25 female
500 mg/kg bw : 25 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: The dose levels for this study were selected after evaluation of a separate dose
range finding study - Positive control:
- No data
- Parental animals: Observations and examinations:
- Mortality, Clinical sign, body weight, food consumption were examined.
- Oestrous cyclicity (parental animals):
- corpora lutea graviditatis and implantation sites were examined.
- Sperm parameters (parental animals):
- no data available
- Litter observations:
- live or death fetal fetus, (after ca. Day 16 of gestation), a late embryonic death (ca Day 12-16) or an early embryonic death (death judged to have occurred prior to ca Day 12) and fetal weight were examined.
- Postmortem examinations (parental animals):
- gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- externally visible abnormalities, visceral and skeletal abnormalities
- Statistics:
- Maternal body weight gains were analyzed by analysis of variance, treatmentgroups being compared using an F-protected Least Significant Difference (LSD)procedure.
For other parameters no formal statistical analyses were considered necessary,
interpretation of the data being based on inspection of the individual and groupvalues. - Reproductive indices:
- no data available
- Offspring viability indices:
- no data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight gain and food consumption
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight gain and food consumption
- 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Description (incidence and severity):
- Maternal toxicity was observed
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effect observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- other: effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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 specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- effects observed, treatment-related
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No adverse effect observed
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- other: effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The NOAEL value was considered to be 250 mg/kg bw per day and LOAEL value was considered to be 500 mg/kg bw per day in female Sprague-Dawley rat when exposed to Ethanol, 2-(hydroxymethylamino).
- Executive summary:
In a reproductive study, the effect of test substanceEthanol, 2-(hydroxymethylamino)in femaleSprague-Dawleyrat were evaluated. The test substance was administered by oral-gavage in the concentration0, 100, 250 and 500 mg/kg/day.Maternal toxicity was observed at 500 mg/kg/day indicated by gastro-intestinal abnormalities, reduced body weight gain and reduced food consumption during the treatment period. There was a moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses at 500 mg/kg/day. Therefore,The NOAEL value was considered to be 250 mg/kg bw per day and LOAEL value was considered to be 500 mg/kg bw per day in femaleSprague-Dawleyrat when exposed toEthanol, 2-(hydroxymethylamino).
Reference
Food consumption: Reduction in food consumption was observed at 500 mg/Kg bw
Gross pathology: Gastro-intestinal abnormalities were observed at 500 mg/Kg bw
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is Klimisch 4 and from HPVIS
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
NOAEL value was considered to be 250 mg/kg bw per day and LOAEL value was considered to be 500 mg/kg bw per day in female Sprague-Dawley rat when exposed to 2-[hydroxy(methyl)amino]ethanol.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from review article or handbook
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- In developmental toxicity study, the effect of test substance Ethanol, 2-(hydroxymethylamino) in female Sprague-Dawley rat were evaluated
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ethanol, 2-(hydroxymethylamino)
- Molecular formula (if other than submission substance): C3H9NO2
- Molecular weight (if other than submission substance): 91.1091 g/mole
- Substance type: Organic - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- - Source: No data available
- Age at study initiation: Approximately 9 weeks
- Diet (e.g. ad libitum):Food ad libitum
- Water (e.g. ad libitum):water ad libitum - Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:The test chemical was dissolved in distilled water to give a dose range of 0, 100, 250 and 500 mg/kg/day
VEHICLE
- Justification for use and choice of vehicle (if other than water):Distilled water
- Concentration in vehicle:0, 100, 250 and 500 mg/kg/day - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Details on mating procedure:
- - M/F ratio per cage: 2 females to each male
- Length of cohabitation: cohabitation with a male was continuous until mating was detected
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy A vaginal lavage was examined each morning and the day of detection of sperm in the lavage, or of a copulatory plug in situ, was considered as Day 0 of gestation.
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Duration of treatment / exposure:
- 20 days after gestation.
Exposure Period: 6 - 16 days, inclusive of gestation - Frequency of treatment:
- Once daily
- Duration of test:
- 20 days after gestation.
- Remarks:
- 0, 100, 250 and 500 mg/kg/day
- No. of animals per sex per dose:
- Total:100
0 mg/kg bw : 25 female
100 mg/kg bw : 25 female
250 mg/kg bw : 25 female
500 mg/kg bw : 25 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Further details on study design
- Dose selection rationale: The dose levels for this study were selected after evaluation of a separate dose
range finding study (IRI Project No. 438026).
- Rationale for animal assignment (if not random): No data available
- Other: No data available - Maternal examinations:
- Mortality, Clinical sign, body weight, food consumption, gross pathology and histopathology were examined.
- Ovaries and uterine content:
- corpora lutea graviditatis and implantation sites were examined.
- Fetal examinations:
- live or death fetal fetus, (after ca. Day 16 of gestation), a late embryonic death (ca Day 12-16) or an early embryonic death (death judged to have occurred prior to ca Day 12) and fetal weight, externally visible abnormalities, visceral and skeletal abnormalities
- Statistics:
- Maternal body weight gains were analyzed by analysis of variance, treatmentgroups being compared using an F-protected Least Significant Difference (LSD)procedure.
For other parameters no formal statistical analyses were considered necessary,
interpretation of the data being based on inspection of the individual and groupvalues. - Indices:
- No data available
- Historical control data:
- No data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- 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:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- not specified
- 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:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Body weight and weight gain Reduction in body weight was observed at 500 mg/Kg bw
Food consumption: Reduction in food consumption was observed at 500 mg/Kg bw
Gross pathology: Gastro-intestinal abnormalities were observed at 500 mg/Kg bw
No effect was observed on the dam or conceptus at 250 mg/kg bw - Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- other: No adverse effect observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- other: adverse effect observed
- Abnormalities:
- not specified
- Localisation:
- not specified
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- effects observed, treatment-related
- Visceral malformations:
- effects observed, treatment-related
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses were observed at 500 mg/kg bw as compared to control.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
- other: No effect observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The NOAEL value of the substance Ethanol, 2-(hydroxymethylamino) for developmental toxicity to fetal is 250 mg/kg bw/day and LOAEL value is 500 mg/kg bw/day.
- Executive summary:
In developmental toxicity study, the effect of test substance Ethanol, 2-(hydroxymethylamino) in femaleSprague-Dawleyrat were evaluated. The test substance was administered by oral-gavage in the concentration 0, 100, 250 and 500 mg/kg/day.Under the conditions of this study, no effect was seen on the dam, or conceptus, at dose levels of up to 250 mg/kg/day. There was a moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses at 500 mg/kg/day. Maternal toxicity was observed at 500 mg/kg/day indicated by gastro-intestinal abnormalities, reduced body weight gain and reduced food consumption during the treatment period.The NOAEL value of the substanceEthanol, 2-(hydroxymethylamino) for developmental toxicity to fetal is 250 mg/kg bw/day and LOAEL value is 500 mg/kg bw/day.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is Klimisch 4 and from HPVIS
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
Developmental toxicity:
In a study, 2-[hydroxy(methyl)amino]ethanol has been investigated for developmental toxicity to a greater or lesser extent. Study based on in vivo experiment data in rodents, i.e. most commonly in rats for 2-[hydroxy(methyl)amino]ethanol.
In a experimental study given by (HPVIS) EPA (U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 1986), the effect of test substance Ethanol, 2-(hydroxymethylamino) in Sprague-Dawley female rat were evaluated. The test substance was administered by oral-gavage in the concentration 0, 100, 250 and 500 mg/kg/day. no effect was observed on the dam, or conceptus, at dose levels of up to 250 mg/kg/day. The developmental effect such as moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses at 500 mg/kg/day. Maternal toxicity was observed at 500 mg/kg/day indicated by gastro-intestinal abnormalities, reduced body weight gain and reduced food consumption during the treatment period. Therefore, NOAEL value was considered to be 250 mg/kg bw per day and LOAEL value was considered to be 500 mg/kg bw per day in female Sprague-Dawley rat when exposed to 2-[hydroxy(methyl)amino]ethanol.
Thus, based on the above study on 2-[hydroxy(methyl)amino]ethanol, it can be concluded that NOAEL value is 250 mg/kg bw for developmental toxicity. Thus, comparing this value with the criteria of CLP regulation, 2-[hydroxy(methyl)amino]ethanol can be can be considered as Not Classified for developmental toxicity.
Justification for classification or non-classification
Based on the above study on 2-[hydroxy(methyl)amino]ethanol, it can be concluded that NOAEL value is 250 mg/kg bw for developmental toxicity. Thus, comparing this value with the criteria of CLP regulation, 2-[hydroxy(methyl)amino]ethanol can be can be considered as Not Classified for Reproductive and developmental toxicity.
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.
