Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: generally accepted scientific principles and well documented study details, acceptable for assessment
Deviations:
not specified
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
Molecular formula:
C4H9NO2 (amide) & C6H11NO3 (amido ester)
IUPAC Name:
Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
Test material form:
liquid

Test animals

Species:
mouse
Strain:
other: Royalhart
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The 75% concentration of the test substance in water was administered orally to female mice. Ten animals per group received doses/20 g mouse of 0.5, 0.6, 0.7 and 1.0 cc and a mortality curve was further calculated based on a 14-day observation period.
Doses:
doses/20 g mouse of 0.5, 0.6, 0.7 and 1.0 cc
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The LD-50 was evaluated using the Miller-Tainter method.

Results and discussion

Preliminary study:
-
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 22 880 mg/kg bw
Based on:
act. ingr.
Mortality:
Mortality was observed from the dose of 0.6 cc and above.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 for the test substance in mice was determined to be 0.61 mL. Based on a bodyweight of 20 g and a purity of 75%, this corresponds to 22880 mg a.i./kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance (purity: 75%) according to the Miller-Tainter method. A 75% concentration of the test substance in water was administered orally to female mice. Ten animals (20 g bodyweight) per group received doses of 0.5, 0.6, 0.7 and 1.0 mL and a mortality curve was calculated based on a 14 d observation period. The LD50 was evaluated using the Miller-Tainter method. Mortality was observed from the dose of 0.6 mL and higher. Under the study conditions, the LD50 for the test substance in mice was determined to be 0.61 mL. Based on a bodyweight of 20 g and a purity of 75%, this corresponds to 22880 mg a.i./kg bw (South Mountain Laboratories, 1972).

Categories Display