Amides, tall-oil fatty, N,N'-(iminodi-2,1-ethanediyl)bis-, maleated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21-08-2012 to 12-09-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid

EC Number:

806-510-7

Cas Number:

1393571-43-1

Molecular formula:

NA

IUPAC Name:

Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid

Test material form:

other: extremely viscous liquid

Details on test material:

test substance identification: Fatty acids, tall-oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid
Description : dark amber coloured extremely viscous liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 156-174 g
- Fasting period before study: 24 hours before dosing and 3-4 hours thereafter
- Housing: 4/cage in solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1 female in the pre-test (2000 mg/kg bw), 4 females in the main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily; body weight on day 0 (before treatment), day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs ½, 1, 2, and 4 hours after dosing and daily thereafter

Statistics:

NA, limit test

Results and discussion

Preliminary study:

No mortality at 2000 mg/kg bw

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Hunched posture and lethargy in one animal on day 0

Gross pathology:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 after oral application of the test substance is > 2000 mg/kg bw

Executive summary:

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations. No mortality was observed. The LD50 is > 2000 mg/kg bw.