Amides, C12-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From February 20, 1996 to April 11, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

KL2 due to RA

Justification for type of information:

Refer to the section 13 for details on the category justification.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

EC Number:

931-335-9

Cas Number:

90622-74-5

Molecular formula:

not applicable

IUPAC Name:

Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: 152-174 g
- Fasting period before study: Overnight
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: Rat and mouse expanded diet no. 1, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: Atleast 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 39-65
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.99 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 d
- Frequency of clinical observation: 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 d
- Frequency of weighing: On Days 0, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination

Statistics:

None

Results and discussion

Preliminary study:

No deaths or clinical signs of toxicity were observed

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: None

Mortality:

No mortality

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

No abnormalities noted at necropsy

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 in rats was >2000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in Sprague-Dawley CD rats according to OECD Guideline 401 and EU Method B1, in compliance with GLP. A group of 10 fasted animals (five males and five females) was administered a single oral dose of test substance at a dose level of 2000 mg/kg bw. The animals were observed for 14 d after dosing, then sacrificed and subjected to gross pathological examination. No mortalities and no signs of systemic toxicity were observed during the study. All animals showed expected gain in body weight. No abnormalities were observed at necropsy. Under the study conditions, the LD50 in rats was >2000 mg/kg bw (Hempstock, 1996).