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EC number: 251-974-0 | CAS number: 34375-28-5
Toxicological information
Toxicity to reproduction
Administrative data
- 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
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Developmental Toxicity/Teratogenicity
- Author:
- (HPVIS) EPA
- Year:
- 1 990
- Bibliographic source:
- U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 1990
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 2-(hydroxymethylamino)ethanol
- EC Number:
- 251-974-0
- EC Name:
- 2-(hydroxymethylamino)ethanol
- Cas Number:
- 34375-28-5
- Molecular formula:
- C3H9NO2
- IUPAC Name:
- 2-[hydroxy(methyl)amino]ethanol
- Details on test material:
- - 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
- Physical state: Liquid
- Impurities (identity and concentrations): Purity: 98.5%
Constituent 1
- 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
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- 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
Examinations
- 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
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Description (incidence and severity):
- Maternal toxicity was observed
Details on results (P0)
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
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 levels (P0)
open allclose all
- 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
Target system / organ toxicity (P0)
- 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
Results: P1 (second parental generation)
General toxicity (P1)
- 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 / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- 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
Target system / organ toxicity (P1)
- 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
Results: F1 generation
General toxicity (F1)
- 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
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
open allclose all
- 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
Target system / organ toxicity (F1)
- 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
Results: F2 generation
General toxicity (F2)
- 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
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- 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
Target system / organ toxicity (F2)
- 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
Overall reproductive toxicity
- 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
Applicant's summary and conclusion
- 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).
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