Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 - 17 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Bio-Terge PAS 7S-DRY
- Physical state: solid
- Analytical purity: >98%
- Lot/batch No.: PG12122011 (dried from industrial lot 7476775)
- Expiration date of the lot/batch: 12 December 2013
- Stability under test conditions: stable
- Storage condition of test material: Controlled room temperature (15-25 °C, < 70 % RH)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: Young adult
- Weight at study initiation: 201-251 g
- Fasting period before study: none
- Housing: individually caged in Type II polypropylene/polycarbonate cages
- Diet: ad libitum - ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15-20/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back of each animal
- % coverage: approx 10 %
- Type of wrap if used: Sterile gauze pad kept in place with an adhesive hypoallergenic plater and wrapped with a semi-occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: Water at body temperature
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes (sample moistened with sufficient water to ensure good skin contact)

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations on the day of treatment at 1 & 5 hours after application and once per day for 14 days thereafter. Bodyweights recorded on Day 0 (before test item administration) and on Days 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
Administration of the test item at a dose level of 2000 mg/kg body weight did not cause any mortality.
Clinical signs:
No clinical signs were observed after treatment with the test item or during the 14-day observation period.
Body weight:
The body weight and body weight gain of animals did not show any test item-related effect.
Gross pathology:
There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. The unilateral pelvic dilatation of the kidneys, observed in two male animals is considered to be an incidental macroscopic finding.
Other findings:
There were no observed local dermal signs after treatment with the test item at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity of the susbtance is > 2000 mg/kg bw.