1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 February 1990 - 20 February 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched

EC Number:

932-122-3

Molecular formula:

NA

IUPAC Name:

1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched

Test material form:

liquid

Details on test material:

Chemical name: 1,3-Propanediamine, N-[3-(C11-C14-alkyloxy)propyl]-, branched
EC no.: 932-122-3

To the best of knowledge, the sample used is representative to the boundary composition.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., England
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males: 120-146g and females 129-140g
- Fasting period before study: overnight
- Housing: animals were housed in groups of up to six by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet (e.g.ad libitum ): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2 February 1990 To: 20 February 1990

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: depends on dose level between 2.5 and 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): For the purpose of this study the test material was freshly prepared, as required, at the appropriate concentration as a solution in arachis oil B.P

Doses:

range finding study:
2000, 200 and 25 mg/kg bw

main study:
200 mg/kg bw

No. of animals per sex per dose:

Range finding:
2

Main study:
5

Control animals:

no

Details on study design:

range finding:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: on the day of dosing animals were weighed
- Necropsy of survivors performed: no
- Other examinations performed: none

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

none

Results and discussion

Preliminary study:

In the range finding study all rats died at 2000 mg/kg bw on day 1 and one male animals died on day 4.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

In the main study a limit test was performed with doses of 200 mg/kg bw none of the animals died.

Clinical signs:

other: Signs of toxicity were confined to hunched posture and pilo-erection.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) o f the test material, LILAFLOT D817, to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight. At 200 mg/kg bw 1/14 animals died. LD50 is expected to be > 300 mg/kg: The classification under GHS is Toxicity Category IV.

Executive summary:

A study was performed, according to OECD 401 and under GLP, to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution in arachis oil B.P. in the Sprague-Dawley strain rat . In a range-finding study (2000, 200 and 25 mg/kg bw, 2 animals sex dose) all animals were found dead the next day at 2000 mg/kg bw and one animal died at 200 mg/kg bw at day 4. Following these results a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation at a dose level of 200 mg/kg bodyweight. There were no deaths. Signs of toxicity were confined to hunched posture and pilo-erection observed 4 hrs after dosing in all animals and on day one in one male. All animals showed expected gain in bodyweight during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study . The acute oral median lethal dose (LD50) o f the test material, LILAFLOT D817, to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight. Formal classification under GHS is not possible, but LD50 is expected >= 300 mg/kg, using a LD50 cut-off level of 500 mg/kgbw seems appropriate.