9-Octadecenedioic acid

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 (Z)-9-octadecen-1,18-dioic acid (CAS 20701-68-2). In accordance with the ECHA guidance document "Practical guide 6: How to report read-across and categories (2012)", 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:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-9-Octadecene-1,18-dioic acid

Cas Number:

20701-68-2

Molecular formula:

C18H32O4

IUPAC Name:

(Z)-9-Octadecene-1,18-dioic acid

Constituent 2

Reference substance name:

(Z)-9-Octadecen-1,18-dioic acid

IUPAC Name:

(Z)-9-Octadecen-1,18-dioic acid

Details on test material:

- Name of test material (as cited in study report): C18:1 dicarboxylic acid
- Physical state: dark yellow solid
- Analytical purity: ca. 90%
- Lot/batch No.: L93046
- Expiration date of the lot/batch: 1 Jan 1997
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel Switzerland
- Age at study initiation: approximately 6 weeks
- Fasting period before study: overnight
- Weight at study initiation: 143 - 171 g (males), 112 - 143 g (females)
- Housing: in groups of 5/sex in polycarbonate cages containing purified sawdust
- Diet: pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was selected based on the results of a pretest in the laboratory

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): the test substance was heated to approximately 70 °C, mixed with the vehicle and homogenised

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: animals were observed for mortality twice daily; clinical signs were noted at periodic intervals on the day of dosing and daily thereafter for the rest of the observation period; the body weight was recorded on Day 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes

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 during the study period.

Clinical signs:

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

Gross pathology:

No substance-related findings were noted during the necropsy and histopathological examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified