Pentaerythritol, ethoxylated, esters with acrylic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May-June 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study has been conducted according to OECD guideline no. 402 and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol, ethoxylated, esters with acrylic acid

EC Number:

500-111-9

EC Name:

Pentaerythritol, ethoxylated, esters with acrylic acid

Cas Number:

51728-26-8

Molecular formula:

(C2 H4 O)n (C2 H4 O)n (C2 H4 O)n (C2 H4 O)n C17 H20 O8

IUPAC Name:

Pentaerythritol, ethoxylated, esters with acrylic acid (> 1 < 8.5 mol EO)

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Pentaerythritol, ethoxylated, esters with acrylic acid
- Substance type: UVCB
- Physical state: clear, yellowisch liquid
- Lot/batch No.: 0008190677
- Expiration date of the lot/batch: 21 February 2013
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Inc.
- Age at study initiation: young adults
- Weight at study initiation: 200-260 g
- Fasting period before study: not applicable
- Housing: Indiviudally caging
- Diet (e.g. ad libitum): ssnif SM>RM-z+H complete diet ad libitum
- Water (e.g. ad libitum): tap water from the municipial supply
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6:00 a.m. to 6:00 p.m.

IN-LIFE DATES: from 3 May 2012 to 17 May 2012

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24- hour exposure period. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.

Duration of exposure:

The test item was applied as supplied, as a single dermal 24-hour exposure followed by a 14‑day observation period.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed after the treatment with the test substance or during the 14-day observation period. No local signs were obeobserved immediately after treatment or during the 14-day observation period.

Gross pathology:

There was no evidence of test substance-related observations at a dose level of 2000 mg/kg b.w. at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal medial lethal dose (LD50) of the test substance was found to be higher than 2000 mg/kg b.w. in male and female Wistar rats.

Executive summary:

An acute dermal toxicity study was performed with Pentaerythritol, ethoxylated, esters with acrylic acid in CRL:(WI)Wistar rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, as a single dermal 24-hour exposure followed by a 14‑day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).

The results of the study were summarized as follows:

No mortality occurred and no clinical signs were observed after the treatment with the test item or during the 14‑day observation period. After treatment with the test item no local signs were observed or during the 14‑day observation period.The body weight and body weight gain of the treated animals did not show any test item-related effect. There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy.