[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 26- June 10, 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:

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

Test guideline 3

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 C10-20, reaction product with diethylenetriamine

EC Number:

940-308-0

IUPAC Name:

Fatty acids C10-20, reaction product with diethylenetriamine

Test material form:

liquid: viscous

Details on test material:

Test material: Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Old name of the test material: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Storage conditions: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Duration of exposure:

The test item will be held in contact with the skin throughout a 24 hour period.

Doses:

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

No. of animals per sex per dose:

5 female and 5 male

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Mortality: No mortality

Clinical signs: Slight piloerection, bloody nasal discharge, regurgitation were observed in one female only immediately after the removal of the dressing. Bloody nasal discharge was observed in three males animals.

Body weight: A slight weight loss of 2 to 7 g was recorded for 4 out of 5 female animals and for 1 out of 5 male animals during the first week, but 4 of the female animals and all male animals showed weight gain during the second week. The toxicological relevance of this

mild finding cannot clearly be concluded.

Gross pathology: No specif gross pathological changes were recorded.

 

LD 50 cut-off

Dose (Unit)	Number of Animals Investigated	Number of Intercurrent Deaths	LD50
2000 mg/kg bw	5 females	0	>2000 mg/kg bw
2000 mg/kg bw	5 males	0	>2000 mg/kg bw

Under the test conditions a single dermal application of the test item to rats at a dose of 2000 mg/kg b.w. was associated with slight to moderete signs of irritation and signs of toxicity, but no mortality.

Applicant's summary and conclusion

Interpretation of results:

other:

Conclusions:

The dermal LD50 was determined to be > 2000 mg/kg body weight.
The test item doesn't require hazard classification.