Registration Dossier

Diss Factsheets

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

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:
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 study day 8.

Female animals:
Systemic effects: No systemic clinical signs were observed during clinical examination.
Local effects: Skin effects at the application site comprised erythema (grade 1) and scaling and were observed from study day 1 until study day 8.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
Mean body weight of the female animals slightly increased during the first postexposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion