Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance Fatty acids, C18-unsatd., dimers, hydrogenated (CAS No. 68783-41-5). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Remarks:

RCC Notox B. V.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18-unsatd., dimers, hydrogenated

EC Number:

500-231-1

EC Name:

Fatty acids, C18-unsatd., dimers, hydrogenated

Cas Number:

68783-41-5

IUPAC Name:

68783-41-5

Details on test material:

- Name of test material (as cited in study report): Dimer acid
- Physical state: liquid
- Analytical purity: approx. 99 %

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, FRG
- Age at study initiation: 9 weeks
- Weight at study initiation: females 200 g / males 300 g (day of dosing)
- Fasting period before study: fasted overnight until approximately 3 hours after administration of the test substance
- Housing: Animals were individually housed in polycarbonate cages containing purified sawdust (Woody Clean supplied by Broekman Institue, Someren, The Netherlands) as bedding material.
- Diet (ad libitum): standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Test article was administered once only by gavage using a stainless steel stomach cannula attached to a disposable plastic syringe. The dose volume (ml/kg bodyweight) used was calculated as follows: dose (g/kg bodyweight) / specific gravity (g/ml). The specific gravity used was 0.95 g/ml.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Clinical observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration.
Individual bodyweights were measured weekly.
At the end of the study (day 14), all animals were anesthetized by CO2/O2 inhalation and subsequently killed by CO2 and subjected to necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred

Mortality:

no mortality occurred

Clinical signs:

other: No signs of systemic toxicity were observed during the 14 day observation period.

Gross pathology:

Macroscopic examination of animals at termination of the study did not reveal any abnormalities that were considered to be treatment related.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification