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

Endpoint summary

Description of key information

In the oral study 1/6 animals died after a single dose of 2000 mg/kg; LD50 > 2000 mg/kg. Clinical but no systemic effects in the surviving animals.

In the dermal study no animal died (0/10); LD50 > 2000 mg/kg. No clinical and systemic effects, but reversible (within 14 days) formation of erythema, scab and scar.

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:

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

The study was performed according to OECD 423 and EU method B.1tris in a GLP certified testing facility. The database is considered to be reliable (Klimisch score 1).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-05 to 2012-11-29

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

effective dose: 2000 mg/kg bw
corresponding to a volume of 2.05 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

Cutaneous reactions (erythema and scab) were noted in all animals from 24 or 48 h post-dose and were totally reversible in females on day 10 and in males on day 14.

Interpretation of results:

other: not classified according to EU regulation

Conclusions:

The dermal LD50 of the test item 400112 was higher than 2000 mg/kg body weight in the rat.
In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified.

Executive summary:

The test item 400112 was applied onto the intact skin of 10 Sprague-Dawley rats (5 males and 5 females) at a single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 402 and the test method B.3 of the Council regulation No. 440/2008.

No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the dermal LD50 of the test item 400112 was higher than 2000 mg/kg body weight in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study was performed according to OECD 402 and EU method B.3 in a GLP certified testing facility. The database is considered to be reliable (Klimisch score 1).

Justification for classification or non-classification

In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item does not have to be classified.