Octadecene, reaction products with hexadecene, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 July 2019 to 31 July 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

OECD Guidelines for Testing of Chemicals No. 423. Acute Oral Toxicity – Acute Toxic Class Method. Adopted: 17 December 2001

Deviations:

yes

Remarks:

See "Any other information" for details

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris

Deviations:

yes

Remarks:

See "Any other information" for details

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-98-190 (1998)

Deviations:

yes

Remarks:

See "Any other information" for details

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:

Oligomerisation products of alpha-alkenes C16-18 (even numbered), hydrogenated, hydroisomerised

EC Number:

832-827-5

Cas Number:

2241366-04-9

Molecular formula:

Variable - UVCB

IUPAC Name:

Oligomerisation products of alpha-alkenes C16-18 (even numbered), hydrogenated, hydroisomerised

Test material form:

liquid

Details on test material:

Name: SynNova Base Oil
CAS number: 2241366-04-9
Batch/Lot number: TS20371/TS21270
Description: Liquid - water white colorless oil.
Purity: 100%
Expiry date: 25 February 2021/31 July 2021
Storage conditions: Controlled room temperature (15-25°C, ≤70% relative humidity)
Safety precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to ensure personnel health and safety.

Specific details on test material used for the study:

No further details specified in the study report.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Crl:WIWistar rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals / group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 8 weeks old
Body weight at treatment: 195 – 207 g
Acclimation period: at least 5 days
Animal health: Only healthy animals were used for the test. The staff Veterinarian certified their health status.
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: SAFE ¾–S certified wooden chips (J. Rettenmaier & Söhne GmbH + CO. KG, 73494 Holzmühle 1, Rosenberg, Germany) was available to animals during the study. The quality of the bedding was guaranteed by the supplier. Details of bedding quality will be archived with the raw data.
Nesting: ARBOCEL nest building material (J. Rettenmaier & Söhne GmbH + CO. KG, 73494 Holzmühle 1, Rosenberg, Germany) was available to animals during the study. The quality of the nest building material was guaranteed by the supplier. Details of nest building material quality will be archived with the raw data.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22.0 – 24.7°C
Relative humidity: 31 – 65%
Ventilation: 15 – 20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity were recorded at least twice daily during the study.

Food and Water Supply
Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany (Batch number: 747 46230, expiry date: 31 August 2019), ad libitum, except for the night before treatment. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animals received tap water from the municipal supply from 500 mL bottles, ad libitum. The water was fit for human consumption and was considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8200 Veszprém, József Attila u. 36, Hungary).

.Animal Identification
Animals were individually identified using numbers written on the tail with an indelible marker pen. The numbers were given on the basis of Citoxlab Hungary Ltd.'s Master File, for each animal allocated to the treatment groups. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle in the Pharmacy of Citoxlab Hungary Ltd. on the day of administration. Each formulation was stirred continuously with a magnetic stirrer until dose administration procedure was complete.
Name: Corn oil
Batch number: A0395699
Expiry Date: 30 April 2020
Storage condition: Room temperature
Manufacturer: Acros Organics

Justification of the dose:
The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. Limit dose of 2000 mg/kg bw was selected as a starting dose.

Doses:

single dose level of 2000 mg/kg bw.

No. of animals per sex per dose:

6 females (3 per group)

Control animals:

not specified

Details on study design:

Procedure
A single oral gavage administration was followed by a fourteen-day observation. On the night before treatment, the animals were fasted. The food, but not water was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.

OBSERVATIONS
Clinical Observations
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight Measurement
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.

NECROPSY
Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal 40%; Lot No.: 1811347-03, Expiry Date: 31 December 2021, Produced by: AlfasanNederland BV, Kuipersweg 9, Woerden, The Netherlands). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded.

Statistics:

The method used was not intended to allow the calculation of a precise LD50 value.
Clinical signs, body weight, body weight gain and gross macroscopic data were recorded and tabulated.

Results and discussion

Preliminary study:

Initially three females (Group 1) were treated at a dose level of 2000 mg/kg bw. No mortality was observed, thus a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to the test guidelines.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

SynNova Base Oil did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

other: other: All animals were symptom-free from Day 0 up to the end of the 14-day observation period at a dose level of 2000 mg/kg bw.

Gross pathology:

There was no evidence of the macroscopic observations in the animals dosed at 2000 mg/kg bw and terminated on Day 14.

Any other information on results incl. tables

CLINICAL OBSERVATIONS

DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0                                                       SEX: FEMALE

Cage No.

Animal Number

Observations

Observations days

Frequency

0

1

2

3

4

5

6

7-14

30’

1h

2h

3h

4h

6h

1

8742

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

8743

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

8744

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

2

8745

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

8746

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

8747

Symptom Free

+

+

+

+

+

+

+

+

+

+

+

+

+

20/20

Remarks:       + = present     ‘ = minute

                       h = hour

                       Frequency of observation = number of occurrence of observation / total number of observations

 

BODY WEIGHT DATA

DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0                                                                   SEX: FEMALE

Cage No.	Animal Number	Body weight (g) Days				Body Weight Gain (g)
		-1	0	7	14	-1-0	0-7	7-14	-1-14
1	8742	218	200	232	238	-18	32	6	20
	8743	225	206	239	239	-19	33	0	14
	8744	221	202	232	240	-19	30	8	19
2	8745	207	195	225	234	-12	30	9	27
	8746	213	207	231	238	-6	24	7	25
	8747	203	195	233	248	-8	38	15	45
Mean:		214.5	200.8	232.0	239.5	-13.7	31.2	7.5	25.0
Standard deviation:		8.4	5.2	4.5	4.6	5.8	4.6	4.8	10.8

 

NECROPSY FINDINGS

DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0                                                                   SEX: FEMALE

Cage No.	Animal Number	Necropsy Date/ Necropsy Day	External Observations	Internal Observations	Organ/Tissue
1	8742	30 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable
	8743	30 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable
	8744	30 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable
2	8745	31 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable
	8746	31 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable
	8747	31 July 2019 Day 14	No external observations recorded	No internal observations recorded	Not applicable

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the acute oral LD50 value of the test item SynNova Base Oil was found to be above 2000 mg/kg bw in female Crl:WI rats.
According to the GHS criteria, SynNova Base Oil can be ranked as "Unclassified" for acute oral exposure.

Executive summary:

The single-dose oral toxicity of SynNova Base Oil was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in Crl: WI Wistar rats.

 

Two groups of 3 female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1 and 2).

 

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was formulated in corn oil at a concentration of 200 mg/mL at a dose volume of 10 mL/kg bw.

 

Initially three females (Group 1) were treated at a dose level of 2000 mg/kg bw. No mortality was observed, thus a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris.

 

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and 14 (before necropsy). All animals were subjected to a necropsy and a macroscopic examination.

 

The results of the study were summarized as follows:

Mortality

SynNova Base Oil did not cause mortality at a dose level of 2000 mg/kg bw.

 

Clinical Observations

All animals were symptom-free from Day 0 up to the end of the 14-day observation period at a dose level of 2000 mg/kg bw.

 

Body Weight and Body Weight Gain

There were no effects on body weights or body weight gains that could be attributed to treatment with SynNova Base Oil.

 

Necropsy

There was no evidence of the macroscopic observations in the animals dosed at 2000 mg/kg bw and terminated on Day 14.

 

Conclusion:

Under the conditions of this study, the acute oral LD50 value of the test item SynNova Base Oil was found to be above 2000 mg/kg bw in female Crl:WI rats.

 

According to the GHS criteria, SynNova Base Oil can be ranked as "Unclassified" for acute oral exposure.