Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 May - 22 Aug 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2001)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

109884-54-0

Cas Number:

109884-54-0

IUPAC Name:

109884-54-0

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: clear colourless liquid
- Analytical purity: 100%
- Batch No.: OE31003999
- Expiration date of the batch: 03 October 2017
- Storage condition of test material: at room temperature in the dark
- Density: 0.90 g/mL
- pH (1% in water, indicative range): 6.5 - 5.7

Test animals

Species:

rat

Strain:

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

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Mean weight at study initiation: 161 g (body weight variation did not exceed +/- 20% )
- Fasting period before study: Animals were fasted overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: group housing of 3 animals per cage
- Diet: pelleted rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.22 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 animals per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality/Viability: twice daily;
Body weights: Days 1 (pre-administration), 8, 15;
Clinical signs: at periodic intervals on the day of dosing (Day 1), once daily until Day 15
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 based on study results

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off based on OECD TG 423

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and/or piloerection were noted for all animals on Days 1 and/or 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the 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