Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

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 and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

EC Number:

600-026-8

Cas Number:

1000817-22-0

Molecular formula:

Unspecified

IUPAC Name:

Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

Details on test material:

Name of test-item: Kerocom FM 38
Batch identification: 2008250
Purity 100 %
Homogeneity: The test-item was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor
holds this responsibility.
Storage conditions: Room temperature
Physical state/ color: Liquid/ yellow to brownish, clear
Density [g/mL]: 0.961 (determined by Bioassay)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age on day 0: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
Arrival in the testing facility: Acclimatization period at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Identification: Individual identification by cage cards and tail marking.
Body weight on day 0: Animals of comparable weight
Room temperature/relative humidity: The rats were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22 – 26°C for temperature and of 20 – 80% for relative humidity.
Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Makrolon cage, type III (single housing)
Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany). Drinking water: Tap water ad libitum

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Clipping of the fur: About 24 hours before administration
Route of application: Single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semi occlusive dressing (the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG) for 24 hours, afterwards removal of the dressing. Rinsing of the application site with warm water.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Application area: About 40 cm² (corresponds to at least 10% of the body surface)
Time of day of application: In the morning
Observation period: 14 days
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times until the last day of observation.
Mortality: A check for any dead or moribund animal was made at least once each workday, these records are archived by Bioassay.
Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.

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 occurred.

Clinical signs:

other: Male animals: Systemic effects: No systemic clinical signs were observed during clinical examination. Local effects: Skin effects at the application site comprised erythema (grade 1), scaling and incrustations and were observed from study day 1 until stud

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.