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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
RANGE-FINDING TOXICITY DATA: LIST IV
Author:
Smyth HF, Carpenter CP & Weil CS
Year:
1951
Bibliographic source:
AMA Arch Ind Hyg Occup Med (1951) 4:199-122

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
no
Remarks:
pre-dates GLP requirements
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
2-aminoethanol
EC Number:
205-483-3
EC Name:
2-aminoethanol
Cas Number:
141-43-5
Molecular formula:
C2H7NO
IUPAC Name:
2-aminoethanol
Specific details on test material used for the study:
- Name of test material (as cited in journal article): Monoethanolamine (2-aminoethanol)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Not reported
Doses / concentrations
Remarks:
Not reported
No. of animals per sex per dose:
Not reported
Control animals:
not specified
Details on study design:
Not reported

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
320 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:
yes
Lowest effective dose / conc.:
640 mg/kg bw (total dose)
System:
other: Liver or kidney
Organ:
kidney
liver
Treatment related:
yes
Dose response relationship:
not specified

Applicant's summary and conclusion

Conclusions:
The present sub-chronic repeated dose rat toxicity study reported a 90-day (dietary) NOAEL of 320 mg/kg bw/day and a LOAEL of 640 mg/kg bw/day for 2-aminoethanol due to altered liver or kidney weight.
Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.

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