Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Aug 2005 - 25 Jan 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12-Nousan-No.8147
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Inc., Hino Breeding Centre, Shiga, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 309 - 314 g (males), 205 - 221 g (females)
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor. The cages were placed on racks, with an aluminium cage tray under each cage. The cages were changed once a week and the cage trays twice per week. Feed racks were changed every week. All cage material was autoclaved.
- Diet: Pelleted diet CRF-1 (Oriental Yeast Co.Ltd, Tokyo, Japan), ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): More than 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

IN-LIFE DATES: From: 5 Sep 2005 (females) and 12 Sep 2005 (males) To: 20 Sep 2005 (females) and 27 Sep 2005 (males)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area, app. 4 x 5 cm2
- % coverage: Not reported


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Exposed area was cleaned with cotton moistened with water.
- Time after start of Exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No
- For solids, paste formed: Yes, substance was ground in a mortar and moistened with 0.5-1.0 mL water before application.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations of clinical signs and mortality were performed after 10 and 30 minutes, 1, 2, and 4 hrs after treatment (day 0), and once daily for 14 days (day 1-14) thereafter. All animals were weighed on the day of administration (day 0), and on day 7 and 14.
- Necropsy of survivors performed: Yes. Performed after the observation period on all animals.
- Other examinations performed: Clinical signs, body weight, gross pathology (all organs/tissues were examined macroscopically).
Statistics:
Averages and standard deviations were calculated for body weights and body weight gain (the differences from previous values).

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 mortality
Mortality:
There was no mortality.
Clinical signs:
There were no clinical signs during the exposure period or during the observation period.
Body weight:
Administration of the test substance had no effect on the body weight or body weight gain.
Gross pathology:
The retention of a white substance was observed in 3 male rats. However, this is not considered to be test substance-related, as this is a common finding in this strain of rat.

Any other information on results incl. tables

Observed effects of test substance administration:

 Number/sex       dose mg/kg bw.    Clinical signs  Time of death  mortality (%)  
5/male 2000  -  -  0  
5/female 2000  -  -  0

Applicant's summary and conclusion