Octanoic acid, compound with octylamine (1:1)

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:

weight of evidence

Study period:

1988-01-20 to 1988-02-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance. In accordance 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. It is hypothesized that the toxicity of the target chemical can be derived from the respective toxicity data of octylamin, dodecylamine, coco alkylamines and octanoic acid. The underlying scientific rationale is that dissociated product of the target chemical – octylamine and the source chemicals belong to the homologues series of fatty amines and form a “chain length category”, where there is an incremental increase in the number of CH2 units.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

Dodecylamine

EC Number:

204-690-6

EC Name:

Dodecylamine

Cas Number:

124-22-1

Molecular formula:

C12H27N

IUPAC Name:

dodecan-1-amine

Details on test material:

- Name of test material (as cited in study report): Genamin 12 R 100 D
-

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
- male ca. 6 weeks
- female ca. 7 weeks
- Weight at study initiation:
- male mean = 186 g; min = 184 g, max = 190 g; sd = +-2g
- female mean = 182 g; min = 178 g, max = 186 g; sd = +-3g
- Randomized
- Fasting period before study: 16 h before application and 3-4 hours after application of the test substance
- Housing: fully air-conditioned in makrolon cages (type 4) on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- Concentration in vehicle: 20%

Doses:

2000 mg/kg body weight

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: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortalities

Clinical signs:

other: decreased spontaneous activity, coat bristling, squatting posture, stilted gait, irregular respiration

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings execpt in one case (male rat). The macroscopic finding of that animal revealed connation (intergrowth) between the stomach with liver, spleen, pancreas and abdominal wall most probably caused by the corrosive properties of the test material.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute oral toxicity of the target substance was assessed based on the analogue appraoch using dodecylamine as read-across supporting substance. The median lethal dose of Dodecylamine (LD50) was greater 2000 mg per kg body weight.

Executive summary:

The acute oral toxicity of the target substance was assessed based on the analogue approach using dodecylamine as read-across supporting substance.

In a GLP-compliant study according to OECD TG 401, the test material Genamin 12 R 100 D was orally applied to 5 male and 5 female Wistar rats using sesame oil as a vehicle at the limit dose of 2000 mg/kg body weight. After treatment no mortalities occurred during the observation period of 14 days. The LD50 was established at > 2000 mg/kg for both male and female animals. Clinical signs included squatting posture, stilted gait, irregular breathing, and reduced spontaneous activity. Symptoms started between 10-60 minutes after onset of treatment and were present until day 6 (female animals) or day 9 (male animals). Gross pathology revealed no findings except in one male animal. This animal showed partly connation of stomach epithelia with lobes of liver, spleen, pancreas and abdominal wall which was most probably caused by the corrosive properties of the test material..