Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

A relative humidity higher than 70% was registered on 02, 04 & 07 July 2015. The minimum value measured was 73%. This deviation is considered as without impact on the conclusion of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine

EC Number:

291-909-3

EC Name:

Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine

Cas Number:

90506-47-1

Molecular formula:

complex substance

IUPAC Name:

Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine

Test material form:

liquid: viscous

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Arcot 3135 from PCAS, Batch N°80555C079
- Production date: May 2015
- Date received: 12 June 2015
- Expiration date of the batch: May 2016
- Purity test date: 28 May 2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by Elevage JANVIER LABS (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks old.
- Weight at study initiation:
- Fasting period before study:
- Housing: Solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet & water: ad libitum. Drinking water (tap-water from public distribution system) and foodstuff (A04, SAFE) were supplied freely. Food was removed on D-1 and then redistributed 4 hours after the test item administration.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C) & Humidity (%): The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively.
- Air changes (per hr): The rate of air exchange was at least ten changes per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
No vehicle used

MAXIMUM DOSE VOLUME APPLIED: one dose of 2000 mg/kg body weight was applied
The test item was administered by gavage under a volume of 2.22 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.

CLASS METHOD
- Rationale for the selection of the starting dose: cut off value for classification firstly tested.

Doses:

One dose of 2000 mg/kg body weight was applied

No. of animals per sex per dose:

3 (two step study, leading to a total of 6 animals)

Control animals:

yes

Remarks:

3 animals received the control item distilled water, administered by gavage under a volume of 10mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: no
- Other examinations performed: Body weight, Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Back hair appearance.

Results and discussion

Effect levels

Key result

Sex:

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 related to the administration of the test item were observed during the study.

Body weight:

The body weight evolution of the animals remained normal during the study.

Other findings:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item ARCOT 3135 is higher than 2000 mg/kg body weight by oral route in the rat.
The test item ARCOT 3135 does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.

Executive summary:

The test item ARCOT 3135 was administered to a group of 6 females Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No.423 dated December 17th, 2001 and the test method B. I tris of the Council regulation No. 440/2008.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50 of the test item ARCOT 3135 is higher than 2000 mg/kg body weight by oral route in the rat.

The test item ARCOT 3135 does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.