2-ethyl-2-oxazoline

Repeated dose toxicity: oral

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

Test material information

1

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.