Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Aug 2010 - 16 Sep 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study Analytical purity not given, responsibility of the sponsor.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the Government of the United Kingdom 2009
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given; responsibility of the sponsor
- Batch number: 9086
- Expiry date: 23 Dec 2011
- Storage conditions: room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK.
- Strain: HsdRddHan®TM:WIST®TM
- Age at study initiation: 8-12 weeks of age
- Weight at study initiation: males: 324-362 g, females 200-228 g
- Fasting period before study:
- Housing: in suspended solid-floor polypropylene cages furnished with woodflakes; individually during the 24-h exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet (ad libitum): 2014 Teklad Global Rodent diet by Harlan Laboratories
- Water:ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: Surgical gauze and self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period the bandage was removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.

TEST MATERIAL
The test item was weighed out according to each animal's individual body weight and moistened with distilled water prior to application.
The absorption of the test item was not determined.

VEHICLE
distilled water
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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: 0.5, 1, 2 and 4 hours after dosing and subsequently once a day
- Frequency of weighing: on days 0, 7 and 14
- Necropsy of survivors performed: yes, including external examination and opening of the abdominal and thoracic cavities.
- Other examinations performed: daily skin examination for irritation according to Draize system for 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity and no signs of dermal irritation.
Body weight:
One female showed no gain in bodyweight during the first week and bodyweight loss during the second week. One other female showed bodyweight loss during the first week but expected gain in bodyweight during the second week. The remaining animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU