Fatty acids, C14-18 and C16-18-unsatd., maleated

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

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, according to GLP and OECD guidelines, read across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1309959-24-7

Cas Number:

1309959-24-7

IUPAC Name:

1309959-24-7

Test material form:

liquid: viscous

Details on test material:

liquid to highly viscous
yellow

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: app. 10 weeks
- Weight at study initiation: app. 182 g
- Fasting period before study: 16h
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1,2-propanediol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40g/ 100 ml
- Amount of vehicle (if gavage): 5 ml/kg bw
- Justification for choice of vehicle: Good homogeneity in 1, 2 Propanediol

MAXIMUM DOSE VOLUME APPLIED: 2000 mgkg bw, 5 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no acute toxicity expected

DOSAGE PREPARATION (if unusual): For better handling the test item was heated approx. 1 hour at 70°C. The preparations were administered handwarm.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 x 3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of clinical sings several times on the day of administration, and at least once daily thereafter each workday for the individual animals, check for any dead or moribund animals was made at least once each workday, body weights shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred

Clinical signs:

other: No clinical signs were observed

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU