Reaction product of propylidynetrimethanol, propoxylated, reaction products with ammonia and 2,2-Dimethyl-3-(4-morpholinyl)propanal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-04-09-2014-05-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

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:

(3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine

EC Number:

700-879-7

Cas Number:

1379822-00-0

Molecular formula:

NA: UVCB substance

IUPAC Name:

(3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: Male: 252 - 264 g, Female: 252 - 278 g
- Housing: During acclimatisation: 3 animals/sex/cage During the study: animals were housed
individually.
- Diet: The animals received ssniff® SM R/M-Z+H complete diet produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany, ad libitum
- Water: Tap Water
- Acclimation period: Male: 5 days, Female: 110 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Ventilation: 10 - 15 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 am. to 6 pm.

Administration / exposure

Vehicle:

other: Helianthi annui oleum raffinatum

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of animals
- % coverage: 10 % of the total body surface area
- Type of wrap used: Sterile gauze pads

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, the test item was removed, using body temperature water.
- Time after start of exposure: 24 hours

VEHICLE
- Name: Helianthi annui oleum raffinatum
- Batch no: 1304-4573
- Date of expiry: 22.04.2014

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recorded on day 0, on day 7 and on day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: All gross pathological changes were recorded.
- Individual reactions of each animal were recorded at each observation time. Toxic response data are reported by sex and dose level. Nature, severity andduration of clinical observations are described.

Results and discussion

Preliminary study:

In a preliminary study no deaths were found at 2000 mg/kg bw dose levels. Therefore, a limit test was performed.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No behavioural changes or systemic toxic signs were noted during the study. Dermal irritation symptom as erythema and other sign as wound, small wounds and crust were observed on the treatmnt site. The slight redness (score +1) appeared in all males and f

Gross pathology:

All animals survived until the scheduled necropsy on Day 15. External macroscopic changes as wound and crust were detected on the treated skin surface in one male animal and in one female animal,as well as small wounds and crust were detected in one female animal. No macroscopic alterations due to the systemic toxic effects of the test item were found.