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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:
7 January 1987 - 22 January 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The acclimation period prior to the administration of the test material is not specified; the protocol states that it was a minimum of 48 hours. This deviation was not considered to have had an impact on the outcome of the study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Appearance: pink powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Ico rats: OFA.SD (IOPS Caw)
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation (prior to fasting): 182 - 193 g (males); 170 - 185 g (females)
- Fasting period before study: yes (15 - 20 hours)
- Housing: 5 animals in stainless steel mesh cages (343 x 250 x 140 mm)
- Food consumption: ad libitum with the exception of the pre-dose fast and 3 - 4 hours following the administration of the test material.
- Water consumption: ad libitum
- Acclimation period: minimum of 48 hours

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours light-dark cycle was maintained (photoperiod 0730 to 1930).

IN-LIFE DATES: From: 7 January 1987 To: 22 January 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10 % aqueous dispersion of gum arabic
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Preparation of the suspension: the powdered test material was put in a 20 % (w/v) suspension made immediately prior to administration in a 10 % (w/v) aqueous dispersion of gum arabic.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 15 minutes after administration of the test material, then after 1, 2 and 4 hours. Daily observations were then made for the 14 day duration of the observation period.
> weighing: one day before treatment, and on days 1, 8 and 15 after treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in rats dosed with 2000 mg/kg bw.
Clinical signs:
No clinical signs were observed.
Body weight:
No abnormal effects on bodyweight were observed.
Gross pathology:
No gross abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD0 (males and females) was ≥ 2000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.
Executive summary:

An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline OECD 401.

Groups of fasted, 5 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material administered as a 20 % suspension (w/v) in an aqueous dispersion of 10 % (w/v) of gum arabic at a dose of 2000 mg/kg bw and observed for 14 days.

No mortality and no clinical signs were observed during the study. No gross abnormalities were observed at necropsy.

The oral LD0 (males and females) was ≥ 2000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.