Octanoic acid, compound with dicyclohexylamine (1:1)

Endpoint summary

Description of key information

In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) is hydrolytically very unstable so that in aqueous solution a rapid decomposition to the educts can be observed.The substance will rapidly dissociate to octanoic acid and dicyclohexylamine. The time of decomposition was estimated as < 8 minutes. Therefore Octanoic acid, compound with dicyclohexylamine (1:1) is not stable at “standard” testing conditions representative for human and environmental exposure. Hence, it is fully justified to apply the read-across methodology by use of the respective data from the breakdown/decomposition products to describe the toxicological behaviour of the substance to be registered.

Octanoic acid:

Acute toxicity oral:

An evaluation of available acute oral toxicity data is given in the CLH-Report prepared by Umweltbundesamt GmbH

on behalf of AT Competent Authority, Federal Ministry of Agriculture, Forestry, Environment and WaterManagement.

No classification for acute oral toxicity is required. Also according to the HERA (Human Health Risk Assessment) Targeted Risk Assessmentf or fatty acids salts no classification is needed. Citation from HERA: "The available data for fatty acids provide a clear picture of low acute toxicity for this class of chemicals. All oral LD50 values were greater than 2,000 mg/kg, with little mortality being observed even at the highest doses tested in the studies."

Acute Toxicity inhalation:

6 male or female Albino rabbits were exposed to saturated octanoic acid vapour for 4 hours  No mortality was observed. The LC50 was >5 ml/l

Acute dermal toxicity:

The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).

DCHA:

Acute oral toxicity:

The acute oral toxicity of dicyclohexylamine was evaluated in male Wistar rats. The test substnace was administered oral by gavage at doses of 0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw to groups of 10 male animals. Signs of intoxication were tonical cramps, sedation, poor general condition. The LD50 was estimated as 200 mg/kg bw.

Acute toxicity inhalation:

In an acute inhalation toxicity study in 6 male New Zealand Albino rabbits the LC 50 of Dicyclohexylamine was determined as > 1.4 mg/l.

Acute dermal toxicity:

Groups of New Zealand White rabbits received 126 - 316 mg/kg bw undiluted dicyclohexylamine by dermal application for 24 hours and were then observed for 14 days. Signs of intoxication were reduced appetite and activity, increasing weakness, collapse, and death within 16 hours post application from 200 mg/kg bw upwards. The LD50 ranges between 200 and 316 mg/kg bw.

The lowest respective LD50/LC50 is calculated for the entire substance considering the molar mass of 325.5 g/mol forOctanoic acid, compound with N-cyclohexylcyclohexanamine (1:1), 181.32 for DCHA and 144.21 for octanoic acid respectively.

Therefore the respective LD50's/LC50 for Octanoic acid, compound with dicyclohexylamine (1:1) are:

Acute oral toxicity:

LD50: 359 mg/kg b.w.

Acute dermal toxicity:

LD50: 359 mg/kg b.w.

Acute toxicity inhalation:

As for both substances neither mortality, nor significant clinical signs or pathological findings are reported at the highest doses apllied the LC50 for Octanoic acid, compound with dicyclohexylamine (1:1) is set as > 5 mg/l.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

Single oral application by gavage, undiluted test substance., 5 doses, observation time 14 days, determination of signs of intoxication, stat.method:probit analysis.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw

No. of animals per sex per dose:

10

Control animals:

not specified

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

200 mg/kg bw

Based on:

test mat.

Mortality:

Dose: number of dead animals (time of death)// number of rats with symptoms 0.16 ml/kg bw: 0/10 (-) // 10/10 0.18 ml/kg bw: 1/10 (3h) // 10/10 0.20 ml/kg bw: 5/10 (3h) // 10/10 0.25 ml/kg bw: 7/10 (3h) // 10/100.30 ml/kg bw: 10/10 (2h-2d) // 10/10

Clinical signs:

tonical cramps, sedation, poor general condition

Body weight:

no data

Gross pathology:

no data

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The acute oral toxicity of dicyclohexylamine was evaluated in male Wistar rats. The test substnace was administered oral by gavage at doses of 0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw to groups of 10 male animals. Signs of intoxication were tonical cramps, sedation, poor general condition. The LD50 was estimated as 200 mg/kg bw.

Executive summary:

The acute oral toxicity of dicyclohexylamine was evaluated in male Wistar rats. The test substnace was administered oral by gavage at doses of 0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw to groups of 10 male animals. Signs of intoxication were tonical cramps, sedation, poor general condition. The LD50 was estimated as 200 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

359 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

other: literature data

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

fixed concentration procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

6 h

Concentrations:

1.4 mg/l

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

Chamber volume: 35 l
Air flow rate: 4.0 l/min
Vaporized sample: 2.1 g

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 1.4 mg/L air

Based on:

test mat.

Exp. duration:

6 h

Mortality:

none

Clinical signs:

other: slight lethargy

Body weight:

not specified

Gross pathology:

no effects observed

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation toxicity study in 6 male New Zealand Albino rabbits the LC 50 of Dicyclohexylamine was determined as > 1.4 mg/l.

Executive summary:

In an acute inhalation toxicity study in 6 male New Zealand Albino rabbits the LC 50 of Dicyclohexylamine was determined as > 1.4 mg/l.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 000 mg/m³

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

other: literature data

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

not specified

Vehicle:

polyethylene glycol

Duration of exposure:

24 hours

Doses:

not specified

No. of animals per sex per dose:

5

Control animals:

not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

Reversible
skin irritation in all animals, moderate sedation, deep respiration, hunched posture

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).

Executive summary:

The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

359 mg/kg bw

Justification for classification or non-classification

Acute oral toxicity:

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) classification and labelling is required for

Octanoic acid, compound with dicyclohexylamine (1:1) for acute oral toxicity, based on acute oral toxicity value of 359 mg/kg bw. Therefore the substance is classified in category 4 (H312, harmful if swallowed).

Acute dermal toxicity:

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) classification and labelling is required for

Octanoic acid, compound with dicyclohexylamine (1:1) for acute dermal toxicity, based on acute dermal toxicity value of 359 mg/kg bw. Therefore the substance is classified in category 3 (H312, toxic in contact with skin).

Acute toxicity inhalation:

The respective criteria are not met.

The estimated LC50 is > 5 mg/l.

Octanoic acid, compound with dicyclohexylamine (1:1)

is therefore not classified for acute toxicity by inhalation.