Fatty acids, C8-16

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

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 octanoic acid (CAS 124-07-2). In accordance with 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 the study was conducted with a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octanoic acid

EC Number:

204-677-5

EC Name:

Octanoic acid

Cas Number:

124-07-2

Molecular formula:

C8H16O2

IUPAC Name:

octanoic acid

Details on test material:

- Name of test material (as cited in study report): Prifrac 2901
- Physical state: Liquid
- Analytical purity: 99%
- Composition of test material, percentage of components: C6: 0.5%; C8: 99%; C10: 0.5%
- Storage condition of test material: At ambient temperature
-Stability: Stable at storage conditions

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, Sultzfeld, FRG
- Age at study initiation: 7 weeks
- Weight at study initiation: Males weighed 206-230 g and the females 170-181 g
- Fasting period before study: Overnight (prior to dosing) until approximately 3.5 hours after administration
- Housing: Individually in polycarbonate cages containing purified sawdust as bedding material
- Diet: Standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, the Netherlands)
- Water : Tap-water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for any signs of toxicity approximately once every two hours after dosing and once daily thereafter for 14 days. Individual bodyweights were measured weekly.
- Necropsy of survivors performed: Yes, at the end of the study (day 14), all animals were anaesthetised by CO2/O2 inhalation, subsequently killed by CO2 and subjected to necropsy
- Other examinations performed: clinical signs, body weight

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 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 revealed firm and/or small white/greyish irregular patches in the forestomach of all animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified