Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Substance type: UVCB
- Physical state: clear, yellowisch liquid
- Lot/batch No.: 0008190677
- Expiration date of the lot/batch: 21 Feb 2013
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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: individually caging
- Diet (e.g. ad libitum): ssnif SM>RM-z+H complete diet ad libitum
- Water (e.g. ad libitum): tap water from the municipal 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 am to 6:00 pm

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 (app. 10% area of the total body surfce) app. 24 hours prior to treatment. The test item was applied as a single dose as suplied to the shaved skin and remained ni 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 crapped 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 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: no details
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
no data

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.
Remarks on result:
other: (No mortality occurred)
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed after the treatment with the test substance or during the 14-day observation period. No local signs were observed immediately after treatment or during the 14-day observation period.
Body weight:
The body weight and the body weight gain of the treated animals did not show any effects related to the test substance.
Gross pathology:
There was no evidence of test substance-related observations at a dose level of 2000 mg/kg bw at necropsy.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The caute dermal median lethal dose (LD50) of the test substance was found to be higher than 2000 mg/kg bw 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 bw in both sexes (5 rats/sex). The test item was applied as supplied, as a single dermal 24 -hour exposure following 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. Bodyweight was measured prior to dosing on Day 0 and on Day 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2 -week observation period (Day 14).

No mortality occurred and no clinical signs were observed after the treatment with the test item 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 at necropsy.