Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid

Endpoint summary

Description of key information

A median lethal dose (LD50) of >2000 mg/kg was assigned to Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid in an acute oral toxicity test. This result was based on an absence of mortality, signs of systemic toxicity, abnormalities following necropsy, and abnormal body weight loss/gain over the study period. Classification as an acute toxic hazard is not required according to CLP Regulation (EC) No 1272/2008.

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:

August 14, 2017 to September 25, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

(RccHan™:WIST)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, United Kingdom
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks of age.
- Weight at study initiation: Body weight variation did not exceed ±20 % of the mean body weight at the start of treatment (average: 167 g; range: 160 - 178 g).
- Fasting period before study: Overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing.
- Housing: Housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK, ad libitum.
- Water: Mains drinking water ad libitum (except for fasting period).
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Dose level: 2000 mg/kg; concentration: 200 mg/mL
- Amount of vehicle (if gavage): Dose volume of 10 mL/kg
- Justification for choice of vehicle: Arachis oil was used because the test item did not dissolve/suspend in distilled water or dimethyl sulfoxide.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
- Necropsy of survivors performed: At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

An acute (oral) toxicity test at 0 and 2000 mg/kg was undertaken for Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid. The registered substance was determined to have a median lethal dose (LD50) of >2000 mg/kg given that no mortality, signs of systemic toxicity, nor abnormal body weight loss/gain was observed in the study. Classification as an acute oral toxin is not required (CLP Regulation (EC) No 1272/2008).

Executive summary:

Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid was assessed for its potential to induce acute toxicity via the oral route in female Wistar rats. The study was performed according to Good Laboratory Practise (GLP) and OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method) without deviation. The test substance was provided as a suspension in arachis oil BP at a dose level of 2000 mg/kg initially in one female as part of a sighting study, and then in a further four females. The dose was administered once via a gavage.

No mortality was recorded in the study. Additionally, all animals experienced normal body weight gain and did not exhibit symptoms of systemic toxicity. Following necropsy and examination, no abnormalities were observed. A median lethal dose (LD50) of >2000 mg/kg was subsequently assigned to Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid. This result infers that the registered substance does not possess properties that would require classification as an acute toxic hazard (CLP Regulation (EC) No 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw