Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]-2-[2-(2-prop-2-enoyloxypropoxy)ethoxymethyl]butoxy]ethoxy]propyl prop-2-enoate

Cas Number:

118800-30-9

Molecular formula:

C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x . x C3 H4 O2

IUPAC Name:

2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]-2-[2-(2-prop-2-enoyloxypropoxy)ethoxymethyl]butoxy]ethoxy]propyl prop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Laromer PO 33 F
- Physical state: yellowish liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (for details see analytical report BASF study-No.: 11L00272)
- Purity test date: 2011-12-19
- Lot/batch No.: 110007P040
- Stability under test conditions: guaranteed by the sponsor
- Storage condition of test material: room temperatur below 25°C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: males: 8 weeks, females: 12 weeks
- Weight at study initiation: 212 ± 7.05g (males); 218.4 ± 4.39 g (females)
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special diets services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h / 12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: app. 40cm²
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h (directly after removal of the semiocclusive dressing)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.89 ml/kg b.w.
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs: several times during exposure, daily thereafter;
body weight: day 0, weekly thereafter and on the last day of observation;
skin findings: 30-60 min after removal of the dressing, weekly thereafter according to Draize

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured

Clinical signs:

no systemic effects were observed

local irritation (erythema up to grade 3, edema up to grade 1) were observed up to day 6 in males and up to day 10 in females. Scaling and incrustations were also observed in 1 and 2 females, respectively.

Body weight:

normal body weight gain

Gross pathology:

no abnormalities found

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

· No mortality occurred

· No signs of systemic toxicity were observed in the animals

· The following test item-related local effects were recorded during the course of the study:

o Very slight to moderate erythema (grade 1 to 3)

o Very slight edema (grade 1)

o Incrustations (in two females)

o Scaling (in one female)

o Findings beyond the application area (in one female)

o All local effects were reversible until day 6 (males) or day 10 (females) at the latest

· The mean body weight of the animals increased within the normal range throughout the study period

· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study