2-hexyldecanoic acid

Endpoint summary

Description of key information

In a study performed with the target substance 2 -hexyldecanoic acid the oral LD50 was > 2020 mg/kg. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 2/24/81

Deviations:

no

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

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

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

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

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 020 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

acute oral toxicity:

The target substance 2 -hexyldecanoic acid 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.

 

In a supporting study with the source substance 2-butyloctanoic acid, 6 Sprague-Dawley rats (3 male and 3 female) were treated with 2000 mg/kg bw test substance by oral gavage according to OECD guideline 423 in compliance with GLP. No animal died during the study, the clinical findings noted were piloerection, hunched posture, salivation, reduced activity, swollen abdomen, difficulty in moving, hairloss on head and red staining on muzzle. Recovery of clinical signs had occurred by day 2 in females and by day 13 in males. The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.

 

In the supporting study, performed with the Source substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid according to OECD guideline 423 in compliance with GLP, two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. All animals survived until the end of the study with showing slight signs of toxicity on the day of treatment. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity and piloerection. All animals were completely recovered after 240 min. Result: LD50: > 2000 mg/kg bw.

 

Under the conditions of another supporting study, a single oral application of the similar substance 2-decyltetradecanoic acid to rats at a dose 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of 2 -decyltetradecanoic acid after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): >5000 mg/ kg body weight.

 

acute toxicity: inhalation
waiving: The target substance has very low vapor pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.

 

acute toxicity: dermal

waiving: The substance does not meet the criteria for classification for acute oral toxicity and STOT.

Supporting: Single dermal application of the source substance Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid to rats, at a dose of 2000 mg/kg body weight was associated with no mortality and no signs of toxicity but slight signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg.

 

Justification for classification or non-classification

2 Hexyldecanoic acid on the available acute toxicity information does not present an acute toxicity hazard and does not require classification according Regulation (EC) No 1272/2008.