Hexanoic acid, 2-ethyl-, C16-18-alkyl 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

Study period:

10 Sep 1991 - 24 Sep 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance Cetyl-2-Ethylhexanoate. According 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:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl 2-ethylhexanoate

EC Number:

261-619-1

EC Name:

Hexadecyl 2-ethylhexanoate

Cas Number:

59130-69-7

Molecular formula:

C24H48O2

IUPAC Name:

hexadecyl 2-ethylhexanoate

Details on test material:

- Name of test material (as cited in study report): Only trade name given
- Chemical denomination: Cetyl-2-Ethylhexanoate
- Batch No.: Lot 120300
- Delivery: August 20, 1991
- Physical state: colourless liquid
- Analytical purity: 100 %
- Stability Pure: stable for at least two years
- Stability in Solvent: stable in Arachis oil
- Expiration date: December 31, 1993

Test animals

Species:

rat

Strain:

other: rat, Bor: WISW (SPF) Cpb

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: mean 174 g (males), 165 g (females)
- Fasting period before study: 16 hours
- Housing: groups of 5 animals in Makrolon Type-3 cages with standard softwood bedding
- Diet: pelleted Altromin Maintenance Diet 1324, Altromin GmbH, Lage, Germany , ad libitum
- Water: tap water , ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Purity: DAB 9

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

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: several times on the application day and twice daily thereafter.
- Frequency of weighing: one day before application, on the day of application, on days 2, 7 and 14.
- Necropsy of survivors performed: yes, external examination and thoracal and abdominal cavities.
- 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.

Remarks on result:

other: rats

Mortality:

No deaths occurred.

Clinical signs:

other: No signs of systemic toxicity were observed.

Gross pathology:

No treatment- related findings.

Any other information on results incl. tables

Mean body weights (g):

Day	Male	Female
-1	182	173
day of application	174	165
2 d	192	178
7 d	224	179
14 d	260	190
Body weight gain	78	17

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