Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to OECD 401. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Pale yellow powder
- Analytical purity: 99.04%
- Lot/batch No.: 5/87; Indent 9200/9622
- Storage condition of test material: Following its arrival in Compound Control this test substance was stored in the dark at ambient temperature.
- Stability: Infra-red spectra of the test substance were taken. There were no significant differences between the spectra and so, on this basis, the test substance was judged to have been stable for the duration of this study.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9-11 weeks old
- Weight at study initiation: males: 181-197 g; females: 132-142 g
- Fasting period before study: All animals were fasted overnight (18 hours).
- Housing: On arrival, animals were housed in single sex groups of up to 12 to a cage; each cage measured 56 cm x 38 cm x 18 cm. Prior to experimentation the animals were rehoused (as single sex groups of four) in cages with stainless-steel wire-mesh floors and tops; each cage measured 38 cm x 25 cm x 18 cm. At least two days before dosing, the rats were housed in groups of two or three animals of the same sex per cage.
- Diet (e.g. ad libitum): PRD, Labsure Animal Foods, Dorset, ad libitum.
- Water (e.g. ad libitum): Filtered water from the public supply, ad libitum.
- Acclimation period: Two weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ºC
- Humidity (%): Not documented.
- Air changes (per hr): Not documented.
- Photoperiod (hrs dark / hrs light): Lighting was automatically switched on for the day (06.00 to 18.00 hours GMT) and off for the night (18.00 to 06.00 hours GMT)


Administration / exposure

Route of administration:
other: intraoesophageal intubation using a ballpoint needle fitted to a syringe
Vehicle:
corn oil
Details on oral exposure:
The test material was administered as a 20% m/v suspension in corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs three times a day for the first three days and daily thereafter. The initial (Day 1), Day 7 and Day 14 body weights were recorded.
- Necropsy of survivors performed: necropsy was not performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the rats died.
Clinical signs:
There were no clinical signs observed.
Body weight:
All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.

Any other information on results incl. tables

Table 7.2.1:      Summary of Acute Oral Toxicity

Males

Females

Dose

Mortality

Time of death

Dose

Mortality

Time of death

2000 mg/kg

0/5

--

2000 mg/kg

0/5

--

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test material in rats administered as a 20% (m/v) suspension in corn oil was greater than 2000 mg/kg.
Executive summary:

Five rats per sex were orally dosed at 2000 mg/kg. Animals were observed for clinical signs three times a day for the first three days and daily thereafter for the remainder of the 14 day observation period. The initial (Day 1), Day 7 and Day 14 body weights were recorded. None of the rats died. There were no clinical signs observed. The acute oral LD50 of the test material in rats administered as a 20% (m/v) suspension in corn oil was greater than 2000 mg/kg.