Naphthenic acids, reaction products with diethylenetriamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-09-04 to 1986-10-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically well performed study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Naphthenic acids, reaction products with diethylenetriamine

EC Number:

268-610-1

EC Name:

Naphthenic acids, reaction products with diethylenetriamine

Cas Number:

68131-13-5

Molecular formula:

not applicable

IUPAC Name:

Naphthenic acids, reaction products with diethylenetriamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% in 2000 mg/kg Group; 5% in 500 mg/kg Group
- Amount of vehicle (if gavage): 10 ml /kg body weight

Doses:

2000 mg/kg (male); 500, 2000 mg/kg (female)

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: Daily during the study
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs During the first 10, 30, 60 minutes, 2, 4 and 6 hours after the administration. Twice daily during days 1-14
body weight: On test day 0, 7 and 14 (after the administration)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

On test day 8, one female animal was found dead in 2000 mg/kg group (20% mortality)

Clinical signs:

other: One female that was found dead on day 8 exhibited clinical signs on day 6 and 7. No clinical sign was found in other animals during the study.

Gross pathology:

The animal died on day 8 was found to have light pink colored lung.

Any other information on results incl. tables

Table: Body weight development
Sex/dose level	Initial body weight	Body weight gain: day 0-7	Body weight gain: day 7-14
Males/2000 mg/kg bw	176	55	40
	180	47	44
	175	50	48
	178	63	52
	186	52	47
	179 ± 4 (n=5)	53 ± 6 (n=5)	46 ± 4 (n=5)
Females/2000 mg/kg bw	175	16	9
	172	28	22
	180	18	7
	180	17	15
	178	-11	*
	177 ± 3 (n=5)	14 ± 15 (n=5)	13 ± 7 (n=4)
Females/500 mg/kg bw	171	34	11
	173	26	11
	170	27	7
	179	31	15
	173	37	8
	173 ± 3 (n=5)	31 ± 5 (n=5)	10 ± 3 (n=5)
^*Found dead

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The median lethal dose of Dodigen 1481 after single oral administration to rats, observed over a period of 14 days is:
LD50 (Rat): greater than 2000 mg/kg body weight

Executive summary:

NA-DETA was given to rats per gavage at dose levels of 2000 mg/kg bw for males and 2000 and 500 mg/kg bw for females.

At 2000 mg/kg bw, one female out of five died 7 days after treatment and exhibited body weight reduction prior to death. The survived animals exhibted transiently reduced body weight gain.

No effect was found for males upon application of 2000 mg/kg bw and for females upon application of 500 mg/kg bw.

No classification is warranted for the acute oral toxicity of NA-DETA