Registration Dossier
Registration Dossier
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EC number: 251-974-0 | CAS number: 34375-28-5
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
50% 2-[(Hydroxymethyl)amino]ethanol in an innocuous substrate was applied to rabbit skin and observed for signs of irritation (duration not specified).
No irritation was observed when rabbits were exposed to 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered not irritating to rabbit skin.
Eye Irritation:
Severe irritation and corneal opacity was observed which lasted for 21 days when rabbits were exposed to undiluted 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered irritating to rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An acute dermal irritation was conducted to assess the irritation potential of 2-[(Hydroxymethyl)amino]ethanol
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-[(Hydroxymethyl)amino] ethanol
Molecular formula: C3H9NO2
Molecular weight: 91.1091 g/mol
Smiles notation: CN(CCO)O
InChI: 1S/C3H9NO2/c14(6)235/h56H,23H2,1H3
Substance Type: Organic
Physical State: Liquid - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: in an innocuous substrate
- Controls:
- not specified
- Amount / concentration applied:
- 50% 2-[(Hydroxymethyl)amino]ethanol in an innocuous substrate
- Duration of treatment / exposure:
- no data available
- Observation period:
- no data available
- Number of animals:
- no data available
- Details on study design:
- no data available
- Other effects / acceptance of results:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- No irritation was observed when rabbits were dermally exposed to 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered not irritating to rabbit skin. - Executive summary:
A skin irritation study was carried out in rabbits to assess the irritation potential of 2-[(Hydroxymethyl)amino]ethanol.50% 2-[(Hydroxymethyl)amino]ethanol in an innocuous substrate was applied to rabbit skin and observed for signs of irritation (duration not specified).
No irritation was observed when rabbits were exposed to 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered not irritating to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the ocular irritation potential of 2-[(Hydroxymethyl)amino]ethanol in rabbits
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-[(Hydroxymethyl)amino] ethanol
Molecular formula: C3H9NO2
Molecular weight: 91.1091 g/mol
Smiles notation: CN(CCO)O
InChI: 1S/C3H9NO2/c14(6)235/h56H,23H2,1H3
Substance Type: Organic
Physical State: Liquid - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100% undiluted test chemical
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 21 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- no data available
- Details on study design:
- no data available
- Other effects / acceptance of results:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Severe irritation and corneal opacity was observed which lasted for 21 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Severe irritation and corneal opacity was observed which lasted for 21 days when rabbits were exposed to undiluted 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered irritating to rabbit eyes. - Executive summary:
An eye irritation study was carried out in rabbits to assess the irritation potential of2-[(Hydroxymethyl)amino]ethanol.100% (undiluted) 2-[(Hydroxymethyl)amino]ethanol was instilled into the eyes of rabbits and observed for signs of irritation till 21 days. Severe irritation and corneal opacity was observed which lasted for 21 days.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered irritating to rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In different studies,2-[(Hydroxymethyl)amino] ethanol has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical2-[(Hydroxymethyl)amino] ethanol and its functionally similar read across substances, Propylene glycol [CAS: 57-55-8] and N-Methyldiethanolamine[CAS: 105-59-9]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
A skin irritation study was summarized in 2-[(Hydroxymethyl)amino]ethanol: Reregistration Eligibility Decision (RED) and RED Fact Sheet, US EPA, 1993, to assess the irritation potential of 2-[(Hydroxymethyl)amino]ethanol. 50% 2-[(Hydroxymethyl)amino]ethanol in an innocuous substrate was applied to rabbit skin and observed for signs of irritation (duration not specified). No irritation was observed when rabbits were exposed to 2-[(Hydroxymethyl)amino]ethanol.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered not irritating to rabbit skin.
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the dermal irritation potential was estimated for 2-[(Hydroxymethyl)amino]ethanol. 2 -[(Hydroxymethyl)amino]ethanol was estimated to be not irritating to the skin of White russian (albino) rabbits.
The experimental and estimated results indicate the possibility of 2-[(Hydroxymethyl)amino]ethanol being not irritating to skin.
These results are further supported by the study summarized in The MAK Collection for Occupational Health and Safety, 1–29, 2012; for the functionally similar read across substance, Propylene glycol [CAS: 57-55-8]. Propylene glycol was applied to the forearm of six human subjects in an epicutaneous study. The volunteers were observed for signs of irritation from 2 hours till 7 days. Propylene glycol was not irritating after two hours on the skin of the forearm. The affected skin areas were followed for seven days and no other signs of irritation were observed.
Hence, propylene glycol can be considered not irritating to human skin.
The above results are also supported by the study summarized in IUCLID Dataset- EUROPEAN COMMISSION – European Chemicals Bureau- 18–FEB–2000; for the functionally similar read across substance, N-Methyldiethanolamine[CAS: 105-59-9].The study was conducted as per Draize method. N-Methyldiethanolamine was applied to rabbit skin and observed for signs of irritation (dose, duration not specified). No known skin reactions were observed. Therefore, N-Methyldiethanolamine (CAS No: 105-59-9) can be considered as not irritating to rabbits skin.
Based on the available data for the target as well as read across chemicals and applying the weight of evidence approach,2-[(Hydroxymethyl)amino] ethanol can be considered not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Eye Irritation:
In different studies,2-[(Hydroxymethyl)amino] ethanol has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical2-[(Hydroxymethyl)amino] ethanol and its structurally similar read across substances, 2-aziridin-1-ylethanol [CAS: 1072-52-2]and N-Methyldiethanolamine[CAS: 105-59-9]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
An ocular irritation study was summarized in 2-[(Hydroxymethyl)amino]ethanol: Reregistration Eligibility Decision (RED) and RED Fact Sheet, US EPA, 1993, to assess the irritation potential of 2-[(Hydroxymethyl)amino]ethanol. 100% (undiluted) 2-[(Hydroxymethyl)amino]ethanol was instilled into the eyes of rabbits and observed for signs of irritation till 21 days. Severe irritation and corneal opacity was observed which lasted for 21 days.
Hence, 2-[(Hydroxymethyl)amino]ethanol can be considered irritating to rabbit eyes.
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the ocular irritation potential was estimated for 2-[(Hydroxymethyl)amino]ethanol. 2 -[(Hydroxymethyl)amino]ethanol was estimated to be severely irritating to the eyes of New Zealand White rabbits.
The experimental and estimated results indicate the possibility of 2-[(Hydroxymethyl)amino]ethanol being severely irritating to eyes.
These results are further supported by the experimental study summarized in The MAK Collection for Occupational Health and Safety, Volume 9, pg 292–294, 2012, for the structurally similar read across substance, N-Methyldiethanolamine[CAS: 105-59-9]. 50 microliters of the test chemical was instilled into eyes of rabbits and effects were observed for 8 days. Symptoms like redness, swelling and clouding of the cornea as well as conjunctival bleeding were observed in rabbits which were reversible after 8 days. Based on these observations, 2, 2’-(methylimino)bisethanol was severely irritating to rabbit eyes.
In an another study summarized in IUCLID Dataset - 2,2'-Methyliminodiethanol; European Chemicals Bureau (ECB), 2000; eye injury in rabbits was recorded in a 10- grade ordinal series and was based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical. This rating was used to assess the ocular irritation potential ofthestructurally similar read across substance, N-Methyldiethanolamine[CAS: 105-59-9]. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol. Primary Eye Irritation score for 2,2'-(methylimino)bisethanol was Grade 4.
Based on the grade,2,2'-(methylimino)bisethanol was considered to be moderately irritating to eyes.
The above results are also supported by the experimental study summarized in Hazardous Substance Data Bank (HSDB), U.S National Library of Medicine, last updated 2006; for the structurally similar read across substances, 2-aziridin-1-ylethanol [CAS: 1072-52-2]. Undiluted 2-aziridin-1-ylethanol was instilled into the eyes of rabbits and observed for signs of irritation till 24 hours. The rabbits were scored for signs of irritation on a scale of 1 -10, where score of 10 was most severe injury. 2-aziridin-1-ylethanol was rated 8 on rabbit eyes on scale of 1-10 with particular attention to cornea after 24 hours exposure.
Hence, 2-aziridin-1-ylethanol can be considered severely irritating to rabbit eyes.
Based on the available data for the target as well as read across chemicals and applying the weight of evidence approach,2-[(Hydroxymethyl)amino] ethanol can be considered severely irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Category 2”.
Justification for classification or non-classification
Available studies for 2-[(Hydroxymethyl)amino] ethanol indicate that it is not likely to any cause irritation to skin, but it causes eye irritation.
Hence,2-[(Hydroxymethyl)amino] ethanol can be classified under the category “Not Classified” for skin and “Category 2” for eyes as per CLP.
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