Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

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)

Version / remarks:

adopted Feb. 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted May 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

adopted August 1998

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

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, C18-unsatd., dimers, compds. with coco alkylamines

EC Number:

614-682-8

Cas Number:

68647-95-0

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines

Details on test material:

- Name of test material (as cited in study report): Fatty acids, C18- unsatd., dimers, compds. with coco alkylamines
- Physical state: highly viscous amber liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (For details see analytical report BASF study-No.: 11S05363)
- Purity test date: 2012-08-08
- Lot/batch No.: BI514173
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wega GmbH, Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: on average 229.8g (males), 213.0g (females)
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad lib., SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: app. 40cm² (= at least 10% of body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing with warm water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.55mL/kg b.w.
- For better handling the test item was heated at 60°C for approx. 1 hour. The test item was administered lukewarm.

Duration of exposure:

24h

Doses:

5000mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin findings according to Draize (30-60min after removal of the dressing and several times until the end of the study)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality occured

Clinical signs:

other: No systemic toxicity was observed in males or females. Well-defined erythema (grade 2) and very slight edema (grade 1) were noted in all male animals from study day 1 until study day 3 after application. Furthermore scaling was observed in 3 male animals

Gross pathology:

No abnormalities detected.

Any other information on results incl. tables

Tabel 1

Nature and duration of local clinical signs(males)
Animal No.:	R 902	R 903	R 904	R 905	R 906
Erythema grade 2:	d1 - d3	d1 - d3	d1 - d3	d1 - d3	d1 - d3
Edema grade 1:	d1 - d3	d1 - d3	d1 - d3	d1 - d3	d1 - d3
Scaling:	d3 - d14	d3 - d8	d3 - d14	d3 - d10	d3 - d14
Incrustations:	d3 - d14	d7 - d8	d7 - d14	d7 - d10	d8 - d14

Table 2

Nature and duration of local clinical signs(females)
Animal No.:	R 907	R 908	R 909	R 910	R 911
Erythema grade 1:	d6 - d9	d6 - d9	d6 - d9	d6 - d9	d6 - d8
Erythema grade 2:	d1 - d3	d1 - d3	d1 - d3	d2 - d3	d2 - d3
Erythema grade 3:	-	-	-	d1	d1
Scaling:	d3 - d9	d3 - d9	d3 - d9	d3 - d10	d3 - d10
Incrustations:	d7 - d14	d6 - d14	d2 - d14	d2 - d9	-

d: day

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information