Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 23 - April 7, 2010

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

EC Number:

273-601-0

EC Name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

Cas Number:

68990-47-6

Molecular formula:

The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2

IUPAC Name:

Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine

Details on test material:

Name: Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
CAS No.: 68990-47-6
Batch No.: TEE3316/22
Expiry Date: November 2011
Physical State at RT: solid
Colour: dark
Purity: 97% w/w; Date of analysis: 11 Feb. 2010
Storage Conditions: at room temperature, protected from light
Solubility in Water: very low
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: females: 8 - 9 weeks, males: 8 - 9 weeks old
- Weight at study initiation: females: 216 - 225 g, males 237 - 254 g
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological control at regular intervals)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 55 ±10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

cotton seed oil

Details on dermal exposure:

The animals were marked for individual identification by tail painting. Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. No less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals. The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. The test item was applied at a single dose, uniformly over an area which was approx. 10% of the total body surface.

Duration of exposure:

The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period residual test item was removed by using lukewarm cottonseed oil. The test item could not be removed fully, and the skin was orange coloured.

Doses:

The test item was applied at a single dose of 2000 mg/kg body weight to each animal.

No. of animals per sex per dose:

Number of animals: 5 male and 5 female.

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen.

Clinical signs:

other: No treatment related effects were observed.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Any other information on results incl. tables

Erythema grade 1 was observed in 3 out of 5 female animals and 2 out of 5 male animals. Desquamations were observed in all the animals. Eschar was observed in 1 out of 5 female and 3 out of 5 male animals. Scratches were observed in 3 out of 5 male animals. All signs of irritation were reversible within the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 was determined to be > 2000 mg Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine /kg body weight.

Executive summary:

the test item Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine was assessed for acute dermal toxicity to rats in an OECD 402 guideline study (GLP) by dermal application. Five male and five female rats were dosed at 2000 mg/kg bw by a single application for 24 hours contact time and vehicle used was cottonseed oil.

No mortality or other signs of toxicity and no treatment related effects to organs were observed. Erythema grade 1 was observed in 3 out of 5 female animals and 2 out of 5 male animals. Desquamations were observed in all the animals. Eschar was observed in 1 out of 5 female and 3 out of 5 male animals. Scratches were observed in 3 out of 5 male animals. All signs of irritation were reversible within the observation period of 14 days.

In summary, under the conditions of the present study, single dermal application of the test item Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to rats at a dose of 2000 mg/kg body weight was associated with slight signs of irritation, but no toxicity and mortality.

The dermal LD50 was determined to be > 2000 mg Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine / kg body weight since neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000 mg/kg body weight.