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
Study period:
(no data on starting date) 25-NOV 1996 (date of report)
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
EC Number:
915-316-2
Molecular formula:
C50H80O4
IUPAC Name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: six weeks old
- Weight at study initiation: 188 +- 2 g for males and 150 +- 5 g for females.
- Fasting period before study: overnight period of approximately 18 hours prior to dosing
- Housing: five rats of the same sex were housed in polycarbonate cages
- Food consumption: A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France) ad libitum.
- Water consumption: filtered water by a Millipore membrane (0.22 µm), ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS:
- Temperature: 21 +- 2°C
- Humidity: 30 to 70 %
- Air changes: 12 cycles/hour of filtered, non recycled air
- Photoperiod: 12-hour light/dark cycle

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Vehicle:
- Concentration in vehicle: no data
- 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: 10 mL/kg
Doses:
5000 mg/kg b.w.
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:
> mortality and clinical signs: observed frequently during the hours after dosing.
Thereafter, observation at least once a day up to the end of the 14-day observation period. (day 15)
> body weights: determined prior to dosing (day 1), on days 8 and 15.
Body weight gain of the treated animals was compared to that of C.I.T. control animals with the same initial body weight.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred in males and females
Clinical signs:
The general behaviour of animals was not affected
Body weight:
No effect was observed, all surviving animals had gained weight
Gross pathology:
Macroscopic examination of the main organs showed no apparent abnormalities

Any other information on results incl. tables

Table 7.2.1/2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

5000

0

0

-

-

0

0

-

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the current study, the test item showed no signs of toxicity in female and male rats over a period of 14 days when given orally once at 5000 mg/kg bw. The LD50 can therefore be concluded to be greater than 5000 mg/kg bw. The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified for acute oral toxicity according to the criteria of Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).



Executive summary:

RHODIASTAB X5 was tested for acute oral toxicity in Sprague-Dawley rats in a limit dose assay.
The test substance, a powder, was administered diluted in corn oil. Animals were fastened overnight prior to treatment. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/kg b.w. administered by gavage in a single oral dose (maximum dose volume of 10 mL/kg b.w).
Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period.

No deaths occurred and no clinical signs were observed during the study. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

As the acute oral LD50 was found to be greater than 5000 mg/kg b.w. under the conditions of the test, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).