2-hexyldecanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November - December 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 2/24/81

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

EPA 540/9-84-014, November 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hexyldecanoic acid

EC Number:

246-885-9

EC Name:

2-hexyldecanoic acid

Cas Number:

25354-97-6

Molecular formula:

C16H32O2

IUPAC Name:

2-hexyldecanoic acid

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Houston, Texas, USA
- Age at study initiation: young adults
- Weight at study initiation: 237 - 253 g (males), 177 - 184 g (females)
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages with paper and aspen bedding, changed three times/week
- Diet: Purina Formulab Chow #5008 ad libitum, no comtaminants were expected to have been present in the feed which would have interfered with or affected the results of the study
- Water: municipal water supply ad libitum from automatic water system, no comtaminants were expected to have been present in the water which would have interfered with or affected the results of the study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 ± 5
- Humidity (%): 30 - 80
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 1995-12-06 To: 1995-12-20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.34 mL/kg body weight
Individual doses were calculated for each animal on its fasted body weight, each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle

Doses:

2020 mg/kg

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: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14.

Statistics:

not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

other: Clinical signs included crust around nose, diarrhea, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, salivation and staining of muzzle. Animals were asymptomatic by Day 6 of the study.

Gross pathology:

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

Other findings:

none

Any other information on results incl. tables

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
	Male	Female	Combined		Male	Female	Combined
2020	0/5	0/5	0/10	-	5/5	5/5	10/10

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral LD50 was determined to be greater than 2020 mg/kg bw in albino rats.

Executive summary:

The test material was evaluated for its acute oral toxicity potential in albino rats when administered as a single gavage dose at a level of 2020 mg/kg to males and females. No mortality occurred during the study. Clinical signs included crust around nose, diarrhea, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, salivation and staining of muzzle. Animals were asymptomatic by Day 6. There was no effect on body weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was determined to be greater than 2020 mg/kg.