Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January to 16 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant with GLP and OECD test guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

EC Number:

903-162-9

IUPAC Name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): EC-903-162-9
- Physical state: Dark brown/black viscous liquid
- Lot/batch No.: LN07006926
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient temperature, in the dark

*EC 903-162-9 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on a sample that contained 40.8% Base oil and 59.2% EC 903-162-9.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK, Margate
- Age at study initiation: approximately 8 to 10 weeks old
- Weight at study initiation: between 200 and 230 g
- Fasting period before study: overnight before dosing
- Housing: Groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 22°C on each day
- Humidity (%): approximately 32% to 47%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 31 January to 16 February 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): Not recorded
- Justification for choice of vehicle: Formulation trial at Charles River Laboratories
- Lot/batch no. (if required): MKBG9425V
- Purity: Not recorded

MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Review of the Sponsor's MSDS indicated LD50 >5000 mg/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 groups of 3 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least 5 times on the day of dosing and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

Statistics:

None

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no unscheduled deaths during the study.

Clinical signs:

other: No adverse clinical signs were recorded in any animal.

Gross pathology:

No macroscopic abnormalities were recorded in any animal.

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 study the median lethal dose level (LD50) of EC 903 162 9 in Sprague-Dawley rats was considered to exceed 2000 mg/kg.
This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes.

Executive summary:

The objective of this OECD 423 study was to assess the adverse effects which can follow within a short period of time after a single oral gavage administration of EC 903-162-9 to rats. The test item was administered to 2 groups, each comprising 3 female Sprague-Dawley rats, at a dose level of 2000 mg/kg. The animals were observed for 14 days after the day of dosing. The test item was formulated in corn oil. The dose volume, 4 mL/kg, was based on the concentration of the test formulation (500 mg/mL). Individual doses were based on each individual animal’s body weight on the day of dosing. The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and gross necropsy findings.

All animals survived treatment and no adverse clinical signs or macroscopic abnormalities were recorded in any animal. Body weight gains were considered to be acceptable for rats of this age and strain. Under the conditions of the study the median lethal dose level (LD50) of EC 903-162-9 in Sprague-Dawley rats were considered to not exceed 2000 mg/kg.