Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 27, 2011 to October 14, 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

EC Number:

701-359-2

Cas Number:

216689-76-8

Molecular formula:

Molecular formula not available for this UVCB.

IUPAC Name:

Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and fatty acids, C18-unsatd., dimers and nonanoic acid

Test material form:

liquid

Specific details on test material used for the study:

Specific Gravity / Density: 1.14 g/cm3; pH: (1% in water, indicative range) 5.5 – 5.5 (determined at NOTOX); Stability at higher temperatures: yes, maximum temperature 40°C.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

strain Crl:WI (Han) (outbred, SPF-Quality).

Sex:

female

Details on test animals or test system and environmental conditions:

Age and body weight: young adult animals (approx. 9 weeks old) were selected. Body weight: variation did not exceed +/- 20% of the sex mean. Identification: earmark. Health inspection: a health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.
Conditions: animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 19.3 – 21.2ºC), a relative humidity of 40-70% (actual range: 44 - 76%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Accommodation: group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. Diet Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). Water: free access to tap water.
Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of test substance and vehicle. In consultation with the sponsor, in order to obtain homogeneity, the test substance and test substance formulations were heated in a water bath. The test substance was heated at a maximum temperature of 40ºC for a maximum of 1 hour and 55 minutes. The test substance formulations were heated at a maximum temperature of 55.8ºC for a maximum of 18 minutes. The test substance formulations were allowed to cool down to a temperature of maximally 38ºC prior to dosing.

Doses:

2000 mg/kg

No. of animals per sex per dose:

Each dose group consisted of 3 animals.

Control animals:

yes

Details on study design:

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

Hunched posture was noted for all animals on Day 1. In addition, one animal showed piloerection on Day 1.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

-

Any other information on results incl. tables

The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the study conditions, the acute oral toxicity of the test substance was > 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100. The substance (dissolved in polyethylene glycol) was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw. Animals were subject to daily observations and weekly determinations of body weight. Microscopic examination was performed at terminal sacrifice (Day 15). No mortality occurred. Hunched posture was noted for all rats on Day 1. In addition, one animal showed piloerection on Day 1. Body weight gain over the study period was similar to that expected of untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute oral toxicity of the test substance to rats was > 2000 mg/kg bw (Stitzinger, 2011).