[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 November 2017 to 28 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

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:

Octadecanoic acid, reaction products with tetraethylenepentamine

Cas Number:

71799-54-7

Molecular formula:

Not applicable - UVCB substance

IUPAC Name:

Octadecanoic acid, reaction products with tetraethylenepentamine

Test material form:

solid

Details on test material:

- Appearance: Amber solid
- Storage: Room temperature (20 ± 5 °C); protected from light.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 160-195 g
- Fasting period before study: Food but not water was withheld over-night prior to dosing and for 3 to 4 hours after dosing.
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air conditioning.
- Diet: The laboratory food was offered at recommended doses each day approximately at the same time.
- Water: Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 23.26 ± 0.16 °C
- Humidity: 53.35 ± 1.86 %
- Photoperiod: 12-hour light /12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no.: L63417

MAXIMUM DOSE VOLUME APPLIED:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test material-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.
- The required amount of the test material (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Animals were observed individually immediately after administration of the test material and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days. Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual weights of animals were measured immediately prior to administration of the test material and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
- Necropsy of survivors performed: Yes, all test animals were subjected to gross necropsy and the results were recorded for each animal.

Statistics:

No statistical analysis was done in conjunction with this study.

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 was observed during the study.

Clinical signs:

other: - Piloerection was observed in animals No 3, 4 and No 5. The symptom started to appear 4 hours post-treatment and it persisted next two days. It reappeared from 10th day and it lasted until the end of the study. - Dyspnoea was observed from the first pos

Gross pathology:

All animals were necropsied. Increased amount of gas in gastrointestinal tract, microsplenia and atrophy of thymus were registered in animals No. 3, 4 and 5.

Any other information on results incl. tables

Table 1: Body Weight

ID	Body Weight (g)			Body Weight Difference (g)
	Initial	Week 1	Week 2	Week 1 - Initial	Week 2 - Initial	Week 2 – Week 1
1	190	195	200	5	10	5
2	185	200	210	15	25	10
3	195	210	160	15	-35	-50
4	160	165	115	5	-45	-50
5	175	180	140	5	-35	-40
6	175	200	200	25	25	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study, the acute oral LD50 of the test material in the female Wistar strain rat is greater than 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guideline OECD 423, under GLP conditions.

The test material was administered as a single oral dose to female Wistar rats, the Acute Toxic Class (ATC) method was used. A limit dose of 2000 mg/kg body weight was used as a starting dose.

The test material administered to 6 females at a limit dose did not cause death. Piloerection and dyspnoea were observed during the observation period. A decrease of body weights in 3/6 animals and stagnation of body weight in one animal were observed between the first and second week after administration of the test item. During necropsy, increased amount of gas in gastrointestinal tract, microsplenia and atrophy of thymus were registered.

Under the conditions of the study, the acute oral LD50 of the test material in the female Wistar strain rat is greater than 2000 mg/kg body weight.