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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:
From 25-JAN-1995 (animal arrived) to 17-FEB-1995 (observation period completed)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RHODIASTAB X2
- Substance type: no data
- Physical state: opaque dark amber liquid and gold solid
- Analytical purity: the analytical purity was the responsability of the Sponsor
- Purity test date: the purity test date was the responsability of the Sponsor
- Lot/batch No.: 9330912
- Expiration date of the lot/batch: no data
- Stability under test conditions: the stability under the storage conditions below was the responsability of the Sponsor
- Storage condition of test material: the test substance was stored at ambient temperature in the Sponsor original container
- Other: the test substance was received on 30 December 1994.

Rhodiastab X2 is the previous name of the same test substance currently commercialised as Rhodiastab 92.

Test animals

Species:
rat
Strain:
other: CD strain (remote Sprague-Dawley origin)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: approximately five weeks old
- Weight at study initiation: 122-146 g for males (body weight at the day prior to dosing) and 130-146 g for females (body weight at the day prior to dosing)
- Fasting period before study: yes
- Housing: five animals (same sex/cage) were housed in stainless grid cages (R.S. Biotech, England) where the grid floors ensured rapid removal of waste material to undertrays which were cleaned out as necessary. The cages were suspended in mobile stainless steel racks.
- Diet (e.g. ad libitum): complete pelleted rodent diet (RMI(E)SQC, Special Diets Services Limited, England), ad libitum. Batch analytical data were supplied by the manufacter.
- Water (e.g. ad libitum): tap water from the public supply (Department of the Environmental regulations, England). Analytical certificates were routinely received from the suplier (Suffolk Water Company).
- Acclimation period: at least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-70 %
- Air changes (per hr): at least 10 complete air changes/hour without re-circulation.
- Photoperiod (hrs dark / hrs light): 12 hours/day


IN-LIFE DATES: From: 3-FEB-1995 To: 17-FEB-1995

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: appropriate concentration to permit administration at a constant volume-dosage of 10 mL/ kg b.w. (no other details)
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.


DOSAGE PREPARATION (if unusual): /


Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (animal sacrifice on day 15)
- Frequency of observations and weighing: the day before dosing, day 1, 8 and 15
- Necropsy of survivors performed: yes (larger organs were sectioned and the gastro-intestinal tract was opened at intervals for examination of the mucosal surfaces. No tissues were retained in fixative.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: three separate recordings of signs during the first hour after dosing and 2 further recordings during the remainder of day 1. From day 2 onwards, the animals were inspected twice daily and recordings were made once daily.
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs were observed during the 14-day observation period.
Body weight:
All animals achieved anticipated body weight gains.
Gross pathology:
Necropsy conduted on day 15 showed no significant abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of Rhodiastab X2 in SD rats was established to exceed 2000 mg/kg body weight.
Based on these results, 1-Phenyldecane-1,3-dione does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the GHS and CLP regulations.
Executive summary:

Rhodiastab X2 (former commercial name of the registered substance) has been tested for acute oral toxicity in CD rats according to OECD guidelines 401 and Directive 92/69/EEC method B1, and in compliance with Good Laboratory Practices. The test substance was administered at a dosage of 2000 mg/kg b.w. to a group of 5 males and 5 females, at a constant volume of 10 mL/kg in maize oil. Examinations for mortality, body weight gain and abnormal clinical signs were performed during the 14-day study period.

No death and no clinical signs were observed during the study. The general behaviour and body weight gain were not affected by treatment. At necropsy, a macroscopic examination revealed no abnormality .

Under the conditions of the test, as the LD50 is higher than 2000 mg/kg b.w., Rhodiastab X2 is not classified according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and Regulation (EC) No 1272/2008 (CLP).

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