Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol

Endpoint summary

Description of key information

Based on the study results, the oral LD50 for the test substance in mice was determined to be 22880 mg a.i./kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Species:

mouse

Strain:

other: Royalhart

Sex:

female

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.

Preliminary study:

-

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.

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

22 880 mg/kg bw

Quality of whole database:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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).

Justification for classification or non-classification

Based on available study results, the test substance does not warrant classification for acute oral toxicity according to EU CLP criteria (Regulation 1272/2008/EC).