Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: The general behaviour of animals was not affected

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).