Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Repeated dose oral toxicity:

Repeated dose dermal toxicity study was performed to determine the oral toxic nature of Ethanol, 2-(hydroxymethylamino). The study was performed using 25 female Sprague Dawley rats at dose levels of 0, 250, 500 or 1000 mg/Kg bw. The chemical was dissolved in distilled water. The animals were observed clinical signs, changes in body weight and food consumption, gross and histopathology was performed. Under the conditions of this study, no effect was seen on the rats, at dose levels of up to 250 mg/kg/day. Repeated dose 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. Hence theNo Observed Adverse Effect Level (NOAEL) for the test compoundEthanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.

Repeated dose dermal toxicity:

13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3. The test chemical was dissolved in distilled water and used at dose levels of 0, 50, 250 or 1000 mg/Kg. The chemical was applied daily (Monday – Friday) at a constant volume of 2 ml/kg over an area of approximately 10% of the total body surface area. The treated area was protected for approximately 6 hours by an occlusive dressing held in place by means of nonirritating tape. The animals were observed for mortality, clinical signs, changes in body weight, water and food consumpton, opthamological, hematological and clinical chemistry signs were recorded and the animals underwent gross and histo- pathology. There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material. No dose related changes in body weight, water and food consumption, ophthalmology and no notable hematological intergroup differences were noted. The most notable clinical signs included scabbing on and yellow staining around the dosing site was observed, which were seen in all dose groups that received the test material. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from USEPA HPVIS report
Qualifier:
according to guideline
Guideline:
other: EPA Guideline 83-3(a)
Principles of method if other than guideline:
Repeated dose dermal toxicity study was performed to determine the oral toxic nature of Ethanol, 2-(hydroxymethylamino) as per the EPA Guideline 83-3(a)
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Troysan 174, (2[(Hydroxymethyl)amino] ethanol)
- IUPAC name: 2-[hydroxy(methyl)amino]ethanol
- Molecular formula: C3H9NO2
- Molecular weight: 91.1091 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 98.5%
- Impurities (identity and concentrations): 1.5%
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
No data
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Food ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data
Route of administration:
oral: gavage
Details on route of administration:
No data
Vehicle:
water
Remarks:
Distilled water
Details on oral 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

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data

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
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
Day 6-16 inclusive of gestation (20 days)
Frequency of treatment:
Once daily
Remarks:
0, 100, 250 or 500 mg/Kg/day
No. of animals per sex per dose:
25 Females
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
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data
Positive control:
No data
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
Viability: at the beginning of each day, and again as late as possible on each day
Reaction: Each day
- Cage side observations checked in table [No.?] were included. All the animals were examined for viability at the beginning of each day, and again as late as possible on each day and reaction to
treatment on each day

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Specific examinations were made 1-1.5 hours after dosing, during which the nature, onset, duration and intensity of any signs were recorded

BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 9, 13, 17 and 20 of gestation

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, The weight of food consumed by each mated female was recorded daily throughout the study, commencing on Day 4 of gestation
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data - Animals fasted: No data - Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes, On Day 20 of gestation, the animals were killed by carbon dioxide asphyxiation. The contents of the thoracic and abdominal cavities were examined
macroscopically for abnormalities

HISTOPATHOLOGY: Yes, The reproductive tract was removed and weighed intact then opened and the contents were examined
Other examinations:
No data
Statistics:
Maternal body weight gains were analyzed by analysis of variance, treatment groups 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 group values.
Clinical signs:
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:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
Clinical signs and mortality: No data

Body weight and weight gain: Reduction in body weight was noted at 500 mg/Kg bw

Food consumption and compound intake: Reduction in food consumption was noted at 500 mg/Kg bw

Food efficiency: No data

Water consumption and compound intake: No data

Opthalmoscopic examination: No data

Haematology: No data

Clinical chemistry: No data

Urinanalysis No data

Neurobehaviour: No data

Organ weights: No data

Gross pathology: No data

Histopathology: Gastro-intestinal abnormalities were noted at 500 mg/Kg bw
Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: No significant observations were made in body weight, food consumption and histopathology at the mentioned dose level
Critical effects observed:
not specified
Conclusions:
The No Observed Adverse Effect Level (NOAEL) for the test compound Ethanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.
Executive summary:

Repeated dose dermal toxicity study was performed to determine the oral toxic nature ofEthanol, 2-(hydroxymethylamino). The study was performed using 25 female Sprague Dawley rats at dose levels of 0, 250, 500 or 1000 mg/Kg bw. The chemical was dissolved in distilled water. The animals were observed clinical signs, changes in body weight and food consumption, gross and histopathology was performed. Under the conditions of this study, no effect was seen on the rats, at dose levels of up to 250 mg/kg/day. Repeated dose 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. Hence theNo Observed Adverse Effect Level (NOAEL) for the test compoundEthanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.

Endpoint conclusion
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 from K4 study report

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from USEPA HPV report
Qualifier:
according to guideline
Guideline:
other: EPA Guideline F 82-3
Principles of method if other than guideline:
13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3.
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Troysan 174, (2[(Hydroxymethyl)amino] ethanol)
- IUPAC name: 2-[hydroxy(methyl)amino]ethanol
- Molecular formula: C3H9NO2
- Molecular weight: 91.1091 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
No data
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
occlusive
Vehicle:
water
Remarks:
Distilled water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in distilled water to give a dose range of 0, 50, 250 or 1000 mg/Kg bw

TEST SITE
- Area of exposure: No data
- % coverage: 10% of the total body surface area
- Type of wrap if used: occlusive dressing held in place by means of nonirritating tape.
- Time intervals for shavings or clipplings: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution): No data
- Constant volume or concentration used: No data
- For solids, paste formed: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): Distilled water
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

USE OF RESTRAINERS FOR PREVENTING INGESTION: No data available
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
13 Weeks
Frequency of treatment:
6hr/d, 5d/wk (Monday - Friday)
Remarks:
0, 50, 250, 1000 mg/kg/day
No. of animals per sex per dose:
Total: 80
0 mg/Kg: 10 males and 10 females
50 mg/Kg: 10 males and 10 females
250 mg/Kg: 10 males and 10 females
1000 mg/Kg: 10 males and 10 females
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: No data
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data
Positive control:
No data available
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available

DERMAL IRRITATION (if dermal study): Yes, inflammation, dermal fibrosis, epithelial hyperplasia and ulceration was noted
- Time schedule for examinations: No data available

BODY WEIGHT: Yes
- Time schedule for examinations: No data available

FOOD CONSUMPTION: yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Y No data available

FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available

WATER CONSUMPTION: Yes
- Time schedule for examinations: No data available

OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before treatment commenced and during Week 12 of the study
- Dose groups that were examined: 0 and 1000 mg/Kg

HAEMATOLOGY: Yes
- Time schedule for collection of blood: during Week 13
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined.: Hemoglobin, total red blood cell count, total white blood cell count, differential white cell count, hematocrit, calculations of absolute indices, and Hepato Quick test (on sample obtained by tail snip without anesthesia)

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: during Week 13
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. blood urea nitrogen, glucose, aspartate aminotransferase, alanine aminotransferase, sodium, potassium, calcium, chloride, total protein, albumin, albumin-globulin ratio, alkaline phosphatase, Creatinine, phosphate, total bilirubin.

URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: No data available sensory activity / grip strength / motor activity / other: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes, After 13 weeks of dosing all rats were killed and necropsied and adrenals, kidneys, liver, ovaries (with fallopian tubes), testes (plus epididymides) were weighed

HISTOPATHOLOGY: Yes, animals from the control group and 1000 mg/Kg underwent histopathological examination of a comprehensive list of tissues. Rats from 50 and 250 mg/Kg dose groups had only lungs, liver, kidneys and skin sections examined.

Tissues examined in situ and fixed: Adrenals, aortic arch, any abnormal tissue, bladder, bone (sternum and rib), brain, eyes, femur, heart, intestine (duodenum, jejunum, ileum, caecum, colon, rectum), kidneys, liver, lungs (perfused), mammary gland, mesenteric lymph node, muscle (thigh), nasal cavity, esophagus, ovaries (with fallopian tubes), pancreas, pituitary, prostate, sciatic nerve, seminal vesicles, skin (normal), skin (treated), spleen, stomach (glandular and nonglandular), spinal cord (cervical, thoracic and lumbar portions), submaxillary salivary gland, submandibular lymph node, testes (plus epididymides), thymus, thyroids, tongue, trachea, uterus
Other examinations:
No data available
Statistics:
Hematology, clinical chemistry, organ weight and body weight data were statistically analysed for homogeneity of variance using the F-max test. If the group variances appeared homogeneous a parametric ANOVA was used and pairwise comparisons made via Student\s t-test using Fischer's F-protected LSD. If the variances were heterogeneous, log or square root transformations were used in an attempt to stabilize the variances. If the variances remained heterogeneous, then a non-parametric test such as Kruskal-Wallis ANOVA was used and pairwise comparisons made via Dunn Z test where considered appropriate.

Organ weights were also analyzed conditional on body weight (i.e. analysis of covariance).

Histopathology data were analayzed using Fischer's Exact Probability test.
Clinical signs:
no effects observed
Dermal irritation:
not specified
Mortality:
mortality observed, non-treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
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
Details on results:
Clinical signs and mortality:
Clinical signs: There were no notable intergroup differences. The most notable clinical signs included scabbing on and yellow staining around the dosing site, which were seen in all dose groups that received the test material.
Mortality: There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material.

Dermal Irritation: No data available

Body weight and weight gain: There were no consistent dose related effects seen in body weight gain.

Food consumption and compound intake: There were no notable intergroup differences in food consumption

Food efficiency: No data available

Water consumption and compound intake: There were no notable intergroup differences in water consumption

Opthalmoscopic examination: There were no abnormal opthalmoscopic findings

Haematology: There were no notable hematological intergroup differences.

Clinical chemistry: No data available

Urinanalysis: No data available

Neurobehaviour: No data available

Organ weights: No detailed data available

Gross pathology: No detailed data available

Histopathology: No detailed data available
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effect observed for clinical signs, body weight, food and water consumption and opthalmology parameters at the mentioned dose level
Critical effects observed:
not specified
Conclusions:
The No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.
Executive summary:

13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3. The test chemical was dissolved in distilled water and used at dose levels of 0, 50, 250 or 1000 mg/Kg. The chemical was applied daily (Monday – Friday) at a constant volume of 2 ml/kg over an area of approximately 10% of the total body surface area. The treated area was protected for approximately 6 hours by an occlusive dressing held in place by means of nonirritating tape. The animals were observed for mortality, clinical signs, changes in body weight, water and food consumpton, opthamological, hematological and clinical chemistry signs were recorded and the animals underwent gross and histo- pathology. There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material. No dose related changes in body weight, water and food consumption, ophthalmology and no notable hematological intergroup differences were noted. The most notable clinical signs included scabbing on and yellow staining around the dosing site was observed, which were seen in all dose groups that received the test material. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Data is from K4 study report

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose oral toxicity:

Data available for the target chemical was reviewed to determine the oral toxic nature of upon repeated exposure by oral route Ethanol, 2-(hydroxymethylamino). The study is as mentioned below:

Repeated dose dermal toxicity study was performed to determine the oral toxic nature of Ethanol, 2-(hydroxymethylamino) (USEPA, 2005). The study was performed using 25 female Sprague Dawley rats at dose levels of 0, 250, 500 or 1000 mg/Kg bw. The chemical was dissolved in distilled water. The animals were observed clinical signs, changes in body weight and food consumption, gross and histopathology was performed. Under the conditions of this study, no effect was seen on the rats, at dose levels of up to 250 mg/kg/day. Repeated dose 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. Hence theNo Observed Adverse Effect Level (NOAEL) for the test compoundEthanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.

Repeated dose dermal toxicity:

Data available for the target chemical was reviewed to determine the dermal toxic nature of upon repeated exposure by dermal route Ethanol, 2-(hydroxymethylamino). The study is as mentioned below:

13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3. The test chemical was dissolved in distilled water and used at dose levels of 0, 50, 250 or 1000 mg/Kg. The chemical was applied daily (Monday – Friday) at a constant volume of 2 ml/kg over an area of approximately 10% of the total body surface area. The treated area was protected for approximately 6 hours by an occlusive dressing held in place by means of nonirritating tape. The animals were observed for mortality, clinical signs, changes in body weight, water and food consumpton, opthamological, hematological and clinical chemistry signs were recorded and the animals underwent gross and histo- pathology. There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material. No dose related changes in body weight, water and food consumption, ophthalmology and no notable hematological intergroup differences were noted. The most notable clinical signs included scabbing on and yellow staining around the dosing site was observed, which were seen in all dose groups that received the test material. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.

Based on the data available for the target chemical, Ethanol, 2 (hydroxymethylamino) does not exhibit toxic nature upon repeated exposure by oral and dermal route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral and dermal route.

Justification for classification or non-classification

Based on the data available for the target chemical, Ethanol, 2 (hydroxymethylamino) does not exhibit toxic nature upon repeated exposure by oral and dermal route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral and dermal route.