Fatty acids, tall-oil, reaction products with 2-[(2-aminoethyl)amino]ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-05 to 2012-11-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD 423 and EU method B.1 tris in a GLP-certified testing facility

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Details on test material:

Sponsor's identification: 400112
Date received: 24 September 2012
Container: brown glass flask (n= I)
Quantity: 93.15 g (container + contents)
Batch No: 0001273679
Colour: yellow-brown
Production date: May 2011
Expiry date: May 2013
Storage: room temperature
Purity: 100% (not purified but used as synthesized)
Composition: UVCB substance

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

effective dose: 2000 mg/kg bw
corresponding to a volume of 2.05 mL/kg bw
using a suitable syringe graduated fitted with an oesophageal metal canula

No. of animals per sex per dose:

6

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

one female was found dead on day 1 after application; the animal showed decrease in spontaneous activity and in muscle tone, diarrhoea and piloerection.

Clinical signs:

other: decrease in spontaneous activity (5/5), muscle tone (5/5), righting reflex (2/5), myosis (3/5), salivation (1/5), lacrymation (1/5), piloerection (5/5) and diarrhoea (2/5). Behaviour was normal from day 4.

Gross pathology:

Macroscopic examination of the dead animal revealed a thinning of the forestomach and red spots on the forestomach. Lysis of the intestinal tract incl. duodenum, jejunum, ileon, caecum, and colon was noted in the dead animal. No other effects were observed.

Macroscopic examination of the surviving animals (5/6) at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to EU regulation

Conclusions:

The LD50 of the test item 400112 was higher than 2000 mg/kg body weight by oral route in the rat.

Executive summary:

The test item 400112 was administered to a group of 6 female Sprague Dawley rats at a single dose of 2000 mg/kg body weight. The experimental protocol was established according to OECD guideline No. 423 and the test method B.1 tris of the Council regulation No. 440/2008.

One rat treated at 2000 mg/kg b.w. died at 25 h and 50 min post-dose during the first step of the study. The mortality was preceded by decrease in spontaneous activity and in muscle tone, diarrhoea and piloerection.

 

In conclusion, the LD50 of the test item 400112 is higher than 2000 mg/kg body weight by oral route in the rat.

In accordance with Regulation EC No. 1272/2008 the test item does not have to be classified.