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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 Mar - 21 Apr 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to the OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Designation as given in study report: CD rats derived from Sprague-Dawley
- Source: Elevage Charles River France, Saint Aubin-lès-Elbeuf, France
- Age at study initiation: approx. 7 weeks
- Mean weight at study initiation: males, 163 g; females, 138 g
- Housing: in groups of 5 per sex and cage, in stainless steel cages
- Diet: UAR A 04 diet pellets (Société UAR, Epinay-sur-Orge, France), ad libitum, except for the night prior testing and during the first 3 to 4 hours following gavage.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was administered unchanged; the application volume was 4.4 mL/kg bw, corresponding to a dose level of 5000 mg/kg bw (density 1.14).
The control animals remained untreated but also were subjected to fasting as for the treated animals.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of treatment, after 30 minutes,1, 2, 4 and 6 hours following gavage; thereafter, twice a day.
- Frequency of weighing: each animal was weighed prior test initiation and once weekly thereafter.
- Necropsy of animals that died: animals that died were weighed and subjected to necropsy as soon as possible.
- Necropsy of survivors: the survivors were sacrificed (CO2) at test endingfor purpose of necropsy, and were subjected to gross pathology.
Statistics:
Student's t-test was used for statistical evaluation of body weight data.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred, and no clinical symptoms indicative of toxicity were seen.
Mortality:
All animals survived.
Clinical signs:
No symptoms of toxicity were observed.
Body weight:
No differences in body weight and body weight gain were noticed between the treated and the control animals.
Gross pathology:
In the stomach of all treated males (10/10) and of 7 treated females (7/10), fragments of polymerised test article were found.
No further abnormalities were noticed at necropsy in the treated and control animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified