Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and test guideline compliant study with no deviations affecting study integrity/validity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan but it was not considered to have compromised the validity or integrity of the study.
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
see above
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test article name : Emulsamine AT-O
Chemical name : alkylamidoamine
Batch Number: 6514
Purity: > 95 %
Origin : Feuchy plant
Expiration date of the lot/batch: july 2003
Physical state: dark brown liquid
Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: 187+/-13g for the males and 177+/-10g for the females
- Fasting period before study: overnight period of approximately 18 hours before dosing but free access to water ; food was given back approximatety 4 hours after administration of the test item.
- Housing: polycarbonate cages with stainless steel lid (48cmx27cmx20cm)
- Diet : free access to A04C pelleted diet (UAR, Villemoisson, Epinay sur Orge, France)
- Water : drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 30 to 70
- Air changes (per hr): 12 cycles /hour of filtered, non recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 22 days
- Clinical signs and mortality : frequent observation during the hours following administration of the test item, then at least once a day until day 15 and 22.
- Body weight : just before administration of the test item on day 1 and then on days 8, 15 and 22.
- Macroscopic necropsy examination : yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Three out of five males and 1/5 female died during the study between day 2 and day 8
Clinical signs:
Hypoactivity or sedation, piloerection, dyspnea, hypersalivation and swollen abdomen were recorded in these animals prior to death as well as in the surviving animals from day 1.
Recovery was complete in almost all surviving males on day 12 but piloerection, dyspnea and swollen abdomen persisted in one male up to day 20.
Body weight:
A reduced weight gain was seen in one of the surviving males between day 1 and day 8. The overall body weight gain of the other animals was similar to that of historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under our experimental conditions, the oral LD50 of the test substance is higher than 2000 mg/kg in rats.
Executive summary:

The acute oral toxicity of the test substance was evaluated in rats according to OECD (No. 401, 24thFebruary 1987) and EC (92/69/EEC, B.1, 31stJuly 1992) guidelines.

The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

The test substance was administered by oral route (gavage) to one group of ten fasted Sprague-Dawley rats (five males and fives females).

The test substance was administered undiluted at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.896 g/ml.

Clinical signs, mortality, and body weight gain were checked for a period of up to 21 days following the single administration of the test item.

All animals were subjected to necropsy.

Three out of five males and 1/5 female died during the study between day 2 and day 8. Hypoactivity or sedation, piloerection, dyspnea, hypersalivation and swollen abdomen were recorded in these animals prior to death as well as the surviving animals from day 1.

Recovery was complete in almost all surviving males on day 12 but piloerection, dyspnea and swollen abdomen persisted in one male up to day 20.

A reduced weight gain was seen in one of the surviving males between day 1 and day 8. The overall body weight gain of the other animals was similar to that of CIT historical control animals. No apparent abnormalities were observed at necropsy in any animals.

Under the experimental conditions, the oral LD50 of the test substance is higher than 2000 mg/kg in rats.

According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance does not present a significant acute toxic risk of swallowed.