Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 30 to May 28, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to EU Method B.1 (Acute Toxicity (Oral)).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): ST 12 C 86
- Physical state: Pale yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Smith, Warlingham, Surrey.
- Weight at study initiation: Males: 268-322 g; females: 198-220 g
- Fasting period before study: Animals were fasted overnight prior dosing.
- Housing: Animals were housed in groups of 5/sex in grid bottomed polypropylene cages.
- Diet: Pelleted rodent diet (modified 41B supplied by Pilsbury’s Limited, Birmingham), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 49-67 %
- Photoperiod: 12 h dark/12 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25 % aqueous solution of gum tragacanth
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test material was suspended in a 0.25 % aqueous solution of gum tragacanth.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined for signs of toxicity or other effects frequently after dosing and then daily for 14 days. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes; on completion of the observation period, all surviving animals were sacrificed by carbon dioxide asphyxiation and subjected to gross necropsy. Animals which died during the course of the study were also subjected to gross necropsy.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
- No mortality was observed.
Clinical signs:
- No clinical signs were observed.
Body weight:
- All animals showed expected gains in bodyweight over the 14 day study period.
Gross pathology:
- No abnormalities were noted at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (limit test) performed according to the E.U Test Method B.1 and in compliance with GLP, a group of Sprague Dawley rats (5/sex) was administered a single oral dose of test material at 2000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or clinical signs were observed. Animals showed expected gains in bodyweight during the study. No abnormalities were noted at necropsy.

Oral LD50 Combined > 2000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.