Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-11-17 to 2009-12-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

EC Number:

944-892-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

SPECIES: rat.

STRAIN: SPF (Specific pathogen free) Sprague-Dawley albino rats.

ORIGIN: Janvier supplier (53940 Le Genest-St-Isle, France).

AGE: about 7 weeks (when put in acclimatization).

NUMBER AND SEX: 6 nulliparous and non-pregnant females.

ACCLIMATIZATION: for a least 5 days prior to the experiment.

WEIGHT: on D-1, the day before the corresponding step of the experiment, animals were weighed. The mean weight was calculated and the acceptable limits were deduced, the externe individual weights of the animals could not deviate from the mean weight by more than +/- 10%.

IDENTIFICATION: the animals were identified individually per cage maximum, by marking with picric acid: the location of the marking, different for each animal, corresponded to a number. A caudal marking represented by a coloured circle with a marker pen enabled to identify the step.

HOUSING: the animals were housed at the rate of 3 per cage mximum, in 31 cm x 46 cm x 19 cm polypropylene cages with stainless steel lid. The bedding renewed regularly, was composed of wood shavings delivered dust-free and sterilized to y radiations. It was supplied by SICSA (94142 Alfortville, France). The cages were placed in limited-access premises, maintained in slight overpressure (a minimum of 10 mm of water), under air conditioned temperature (t = 22 +/- 2°C) and controlled relative humidity (RH = 50 +/- 20%) except during washing cycles and whose renewal in fresh filtered air (on absolut filter) was performed at the rate of about 10 cycles per hour. The artificial lighting enseured a sequence of 12 hours light, 12 hours dark.

FEEDING: the complete diet was supplied under pelleted form A04-10 delivered sterilized to y radiations by SAFE (89290 Augy, France).

DRINKING: the acidified tap water was distributed in polypropylene bottles with stainless steel teat. A sample of water was taken every 6 months at least and sent for physicochemical and bacteriological analysis to a specialized control organization.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test element was administered to a group of experimental animals, by oral route (gavage), at one of the defined doses (2000 mg/kg, 300 mg/kg, 50 mg/kg or 5 mg/kg) according to the available information on the test element.
According to the available information about the toxicity of the test element, the test started on 3 animals (Step 1) receiving a dose of 2000 mg/kg of body weight of test element.
After the 1st step, according to the methodology described in the annex 2d of the OECD guideline 423, the test was performed on 3 other animals receiving the test element at the dose level of 2000 mg/kg of body weight, under the same conditions as the animals from the step 1.

Doses:

2000 mg/kg, 300 mg/kg, 50 mg/kg or 5 mg/kg
Only the dose 2000 mg/kg was testing according to the available information about the toxicity of the test element and according the 1st step of the experimental chronology

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The animals, fasted prior to the test element administration, were weighed again on D1 before administration. The volume per kg of body weight, defined according to the test element density as equal to 2.40 ml/kg, the volumes of test element were calculated for each rat.
The test element was administered in a single dose, orally, by gavage using a syringe with appropriate volume (1 ml), fitted with a suitable sized cannula (76 mm x 15/10th)
After administration, animals were fasted for 3 to 4 hours.
The animals were regularly weighed on D-1 the day before administration then on D1/T0 just before administration of the test element and on D4, D8 and D15 i.e. 3, 7 and 14 days after administration of the test element.
Animals were regularly observed the day of administration (immediately, during the 30 minutes following gavage, 1h, 2h, 3h and 4h after admninistration) then at least once a day for 14 days at least.

Statistics:

the assessment criteria of the toxicity of the test element taken into account were:
- body weight change
- clinical and behavioural signs
- necropsy findings
- the mortality expressed in percentage of compound-related deaths

Results and discussion

Preliminary study:

According to the available information about the toxicity of the test element, the test started on 3 animals (Step 1) receiving a dose of 2000 mg/kg of body weight of test element.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during this test

Clinical signs:

other: A slight piloerection was observed just after treatment. Then, until the end of the experiment (D15), no symptom at all was observed anymore.

Gross pathology:

The post-mortem examination performed at the end of the observation period (D15) revealed no visible organic or tissue macroscopic lesion.

Any other information on results incl. tables

Body weight - Individual values

Dose = 2000 mg/kg

Animals N°		Weight (in g)
		D1	D4	D8	D15	D15 -D1
Step 1	7475	230.7	262.2	270.5	300.2	69.5
	7476	222.6	250.2	265.0	278.3	55.7
	7477	212.8	239.8	248.6	263.6	50.8
Step 2	7478	234.9	260.9	279.0	300.9	66.0
	7479	220.0	244.8	265.2	284.5	64.5
	7480	229.9	254.3	278.4	282.1	52.2
Mean		225.2	252.0	267.8	284.9	59.8
Standard deviation		8.2	8.9	11.2	14.1	7.9

Clinical observations

Dose = 2000 mg/kg

Observation time	Comments	Observation time	Comments
D1 (after treatment)	slight piloerection for all the animals	D6	NTR
D1 T30'	NTR	D7	NTR
D1 T1h	NTR	D8	NTR
D1 T2h	NTR	D9	NTR
D1 T3h	NTR	D10	NTR
D1 T4h	NTR	D11	NTR
D2	NTR	D12	NTR
D3	NTR	D13	NTR
D4	NTR	D14	NTR
D5	NTR	D15	NTR

NTR: nothing to report

Necropsy - Individual observations

Dose = 2000 mg/kg

Animals N°		Death		Comments
		Day	Reason
Step 1	7475	D15	S	NTR
	7476	D15	S	NTR
	7477	D15	S	NTR
Step 2	7478	D15	S	NTR
	7479	D15	S	NTR
	7480	D15	S	NTR

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

According to the results obtained and to the Globall harmonised System (GHS) for the classification and labelling of chemicals, the test element 5 a AVOCUTA(R) -CODE 8700492 was classified in the hazard category 5 with a LD50 higher than 2000 mg/kg in the rat.

Executive summary:

Study: Tp 493 / 09 - 3039

Test element: 5 alpha AVOCUTA(R) - Code 8700492 - Cas: 934551 -20 -9 - Batch 0809402304

Result: The test element administered orraly in 6 female rats at the dose 2000 mg/kg resulted in:

- no mortality

- no significant symptomatology

- no change in the weight growth of the animals

- no visible organic or tissue alteration macroscopically

Conclusion: According to the results obtained and to the Globall harmonised System (GHS) for the classification and labelling of chemicals, the test element 5 alpha AVOCUTA(R) -CODE 8700492 was classified in the hazard category 5 with a LD50 higher than 2000 mg/kg in the rat.