Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-10-2/2001-01-12

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

EC Number:

273-601-0

EC Name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

Cas Number:

68990-47-6

Molecular formula:

The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2

IUPAC Name:

Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine

Details on test material:

Identification: Polyamide CAS No. 68990-47-6
Physical Description: Dark solid
Storage: Room temperature
Density. 1.01 g/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Texas Animal Specialties
- Housing: 1 per cage
- Diet : ad libitum
- Water : ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10/20
- Photoperiod (hrs dark / hrs light): 12 h cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

acetone

Doses:

2020 mg/kg

No. of animals per sex per dose:

5 males and 5 females (nulliparous and non pregnant)

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 mg/kg bw

Based on:

test mat.

Mortality:

One female died during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.

Clinical signs:

other: Clinical signs included activity decrease, diarrhea, polyuria, red fluid around anus and soft feces, which were no longer evident in surviving animals by day 1. Gasping, respiratory chirp, and swollen/stained face were observed only in the animal that die

Gross pathology:

The gross necropsy on the animal that died on test revealed stained/wet/matted fur; tail tip missing; discolored lungs, liver and contents of the stomach and small intestine; gas in the stomach/small intestine and empty large intestine. The gross necropsy on 6 of 9 animals surviving to termination of the study revealed discolored heart and/or lungs; remaining three showed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was evaluated for its acute oral toxicity potential when administered to albino rats by gavage. The acute oral LD50, as indicated by the data, is greater than 2020 mg/kg in males and females.

Executive summary:

The objective of this study was to assess the acute oral toxicity potential of the test substance when administered by gavage to rats in accordance with US OECD Guidelines for the Testing of Chemicals, Vol. 2, Section 4, No. 401, Acute Oral Toxicity, 24 Feb 87. There were no deviations from the protocol which affected the quality or outcome of the study. All procedures used in this study are in compliance with Animal Welfare Act Regulations.

The test substance was evaluated for its acute oral toxicity potential in albino rats when administered as a single gavage dose at a level of 2020 mg/kg to males and females.

One female died during the study. Clinical signs included activity decrease, diarrhea, polyuria, red fluid around anus and soft feces, which were no longer evident in surviving animals by Day 1. Gasping, respiratory chirp, and swollen/stained face were observed only in the animal that died on test.

There was no effect on body weight gain in animals surviving to termination. Abnormal necropsy findings pertaining to the heart and lungs occurred in 6 of 9 terminated animals; findings in the animal dying on test pertained to fur, tail, lungs, liver and contents of the gastrointestinal tract.

The acute oral LD50, as indicated by the data, was determined to be greater than 2020 mg/kg bw.