Registration Dossier

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: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

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))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2000-26-04
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
sponsor's identification: lipacide UG
Description: off white solid
Batch number: 00 171 300
Received: 2000-01-08
Storage conditions: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female Sprague Dawley CD (Crl: CD (SD)IGS BR) strain rats were supplied by Charles River (UK), Kent. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelebile ink-marking on the tail and a number written on a cage card. At the start of the study the males weighed 200 to 206 g, and the females 202 to 225 g, and were approximately eight weeks of age.

The animals were housed in suspended polypropylene cages fournished with woodflakes. The animals were housed individually during the 24 hour exposure period and in groups of five, by sex for the remainder of the study. Free access to mains drinking water and food (rat and mouse SQC expanded Dict No.1, special diets services limite, Witham, Essex, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional devitaions from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give twelve hours light and twelve hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
distilled water
Details on dermal exposure:
One day before treatment the back and the flanks of each animal were clipped free of hair.
a group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg. The appropriate amount of test material, moistened with distilled water, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface). A piece of surgical gauze was placed over the treatment area and semi-occlued with a piece od self adhesive bandage. The animals were caged individually for the 24-hour exposure period. Shortly after dosing, the dressings were examined to ensure that they were securely in place.
Duration of exposure:
24 hour
Doses:
2000 mg/ kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
the animals were observed for deaths or evert signs of toxicity1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
there were no deaths
Clinical signs:
no signs of systemic toxicity were noted during the study
Body weight:
all animals showed expected gain in bodyweight during the study
Gross pathology:
no abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute dermal (LD0) of the test animal, lipacide UG, in the Sprague-Dawley CD strain was found to be higher than 2000 mg/ kg body weight.
Executive summary:

The aim of this study was to assess the acute toxicity of the test item by dermal route.

A limit test was conduced following the OECD guideline n°402, this study complies with the GLP.

2000 mg/kg body weight of the test item was administrated to5 male and 5 female Sprague-Dawley rats.

there were no deaths

no signs of systemic toxicity were noted during the study

all animals showed expected gain in bodyweight during the study

no abnormalities were noted at necropsy

The acute dermal (LD0) of the test animal, lipacide UG, in the Sprague-Dawley CD strain was found to be higher than 2000 mg/ kg body weight.

The test item does not need to be classified in accordance with the Comission Directive 93/21/EEC.