[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 November 2017 to11 December 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 402 (Acute Dermal Toxicity)

Version / remarks:

2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

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: 200-230 g
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 2-3 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: 23.28 ± 0.18 °C
- Humidity: 53.36 ± 1.9 %
- Photoperiod: 12-hour light /12-hour dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving.
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: Test material was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period.

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period (24 hours), any residuals of the test material were removed by using lukewarm water without altering the existing response or integrity of the epidermis.

TEST MATERIAL
- A limit dose of 2000 mg/kg body weight was used as a starting dose. One female was dosed. Test material-related mortality was not observed during 48-hours exposure period. The sighting study was finished; the main test was started with dose of 2000 mg/kg body weight. The additional 2 females were dosed in the Main Study with the dose of 2000 mg/kg body weight.
- Preparation: The required amount of the test material (according to the body weight and dose) was mixed with the vehicle (olive oil) shortly before application according to the actual body weight.

VEHICLE
- Lot/batch no.: L63417
- Olive oil is a standard vehicle according to OECD TG 402

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Animals were observed individually immediately after the application of the test material and then 0.5, 1, 2, 4 and 6 hours later. Each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test material using the Draize criteria.
- Individual weights of animals were determined shortly before the test material was applied and weekly thereafter. Weight differences after first and second week after application were calculated and recorded.
- Necropsy of survivors performed: Yes, all test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Results and discussion

Preliminary study:

One female was dosed. Test material-related mortality was not observed during 48 hours.

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: Animals lived through observation period without signs of intoxication. Neither change of health nor negative skin reactions were registered.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic changes were noticed.

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	200	210	215	10	15	5
2	230	230	230	0	0	0
3	225	230	230	5	5	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the LD50 of the test material is greater than 2000 mg/kg bodyweight.

Executive summary:

The acute dermal toxicity of the test material was determined in accordance with the standardised guideline OECD 402, under GLP conditions.

The test material was applied as a single dermal dose to Wistar rats. A limit dose of 2000 mg/kg body weight was used as the starting dose. One female was dosed. Test material-related mortality was not observed during 48 hours. A total of three female rats were dosed with a limit dose of 2000 mg/kg body weight.

The test material applied to 3 females at a limit dose of 2000 mg/kg body weight did not cause death. The body weight of 2/3 females increased during the study, stagnation of body weight in one female was noticed. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours or 14-day observation period. No dermal changes were observed. During necropsy no macroscopic findings were noticed.

Under the conditions of this study, the LD50 of the test material is greater than 2000 mg/kg bodyweight.