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

Endpoint summary

Description of key information

The analogues of the test substance were tested in an acute oral test in rats (Stilmeadow 2001, Harlan 2012a). No mortality was observed at 2000 mg/kg bw. The LD50 is >2000 mg/kg bw. An analogue of the test substance was tested in an acute dermal toxicity study in rats (BSL 2010a). The LD50 is >2000 mg/kg bw. No inhalation study is available as exposure via the inhalation route is expected to be negligible.

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:

21-08-2012 to 12-09-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study under GLP.

Qualifier:

according to guideline

Guideline:

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

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

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

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

Preliminary study:

No mortality at 2000 mg/kg bw

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Study acoording to the guideline and GLP

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test substance does not need to be classified for acute toxicity.