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

Acute Toxicity: dermal

Administrative data

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)

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

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=1)
Quantity: 93.15 g (container + contents)
Batch No: 0001273679
Production date: May 2011
Expiry date: May 2013
Purity: 100% (not purified but used as synthesized)
Composition: UVCB substance
Colour: yellow-brown
Storage: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.