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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-09-14 until 2006-09-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study according to GLP and current OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, adopted 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: >= 200 g
- Housing: suspended solid-floor polypropylene cages furnished withn woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK , ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25°C
- Humidity: 30 - 70 %
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours of artificial light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: surgical gauze, semi-occluded with self-adhesie bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with cotton woll moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL AND VEHICLE
The test substance was administered at a dose level of 2000 mg/kg bw at a treatment volume of 2.26 mL/kg bw.

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 animals: 5 males, 5 females
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 h hours after dosing and daily thereafter, body weights were recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No adverse effects noted
Mortality:
No mortality was observed.
Clinical signs:
There were no signs of systemic reaction to treatment.
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweitgh over the study period.
Gross pathology:
No abnormalities were noted.
Other findings:
none

Applicant's summary and conclusion