Registration Dossier

Administrative data

Description of key information

In Compliance with the OECD 401 Guidelines:


The aim of this study was to assess the potential toxicity and lethality of a single oral exposure of 2 000mg/kg body weight.


The rats were observed up to 14 days after the oral dose.


No mortality occured, no clinical sign was observed, individual growth weight of the rats remain normal and regular.


Effects on organs: did not show any visible organic or tissular lesion.


=> LD50 oral, rat > 2000 mg/kg bw/d


 


In Compliance with the OECD 402 Guidelines :


A limit test study was conducted to assess the acute toxicity of the test item by dermal route.


2000 mg/kg body weight of the test item was administrated to 5 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.


 


 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
FROM 1997-11-27 TO 1997-12-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, OECD guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Supplier: IFFA-CREDO (69210 - L'arbresle, France)
Age, weight: about 6 weeks, weight between 201 g and 207 g (males and 173 g and 175 g (females) at the beginning of the study
Acclimatization: at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages. Complete pelleted rat maintenance diet UAR A04-10 (91360-Epinay sur Orge, France)
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Animals have been fsted before prior to substance administration by withholding food overnight. They received by gavage, according to the bodyweight, the product diluted with CMC (carboxymethyl cellulose) at 0.5 % (cooper batch F16539) and homogenised with mortar, at the single dose of 2000 mg/kg under a constant volume of 10 mL/kg. The administrated preparation was kept up under magnetic stirring during the treaments.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
14 days after the exposure, rats were sacrified after barbituric anaesthesia, then autopsied. all abnormailities were recorded.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: >= 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No mortality occured
No alteration
Body weight:
individual growth weight normal and regular
Gross pathology:
Effects on organs:
did not show any visible organic or tissular lesions
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC directive, the test substance is unclassified among the substances dangerous if swallowed
Executive summary:

The aim of this study was to assess the toxicity of the test item UG after a single oral exoposure of 2 000mg/kg body weight.


The rats were observed up to 14 days after the oral dose.


No mortality occured, no clinical sign was observed, individual growth weight of the rats remain normal and regular.

Effects on organs: did not show any visible organic or tissular lesions


Lethal Dose 0% (LD0) of the test substance is higher than 2000 mg/kg body weight.

According to the 67/548/EEC directive, the test substance is unclassified among the substances dangerous if swallowed

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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.
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

 


Under the experimental conditions, the oral LD50 value for rats is higher than 2000 mg/kg.


According to the GHS, the test substance is not classified as dangerous if swallowed.


 


The dermal LD50 value for rats was found to be higher than 2000 mg/ kg body weight.


The test item does not need to be classified in accordance with the GHS.