Adipic acid, compound with hexane-1,6-diamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

EC Number:

222-037-3

EC Name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

3323-53-3

Molecular formula:

C6H16N2.C6H10O4

IUPAC Name:

hexanedioic acid - hexane-1,6-diamine (1:1)

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Fasting period before study: yes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

500, 1000, 2000, 4000, 5000, 8000, 10000 mg/kg bw

No. of animals per sex per dose:

1 or 5 animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations: approximately 1-3 hours after dosing and then daily over a period of 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

ca. 4 900 mg/kg bw

Mortality:

All but one of the animals given 5000 mg/kg bw and more died; late deaths were observed. See table below.

Clinical signs:

other: Lethal doses caused seizures. Sublethal doses led to stiff gait, apathy, reduced appetite, diarrhoea, and rough coat.

Gross pathology:

At necropsy, signs of gastro-intestinal tract irritation and intestinal bleeding were found.

Any other information on results incl. tables

Table: mortality data

Dose [mg/kg]	Mortality rate	Death occurred within
10000	1/1	3  hours
8000	5/5	1-2 days
5000	4/5	1-8 days
4000	0/5
2000	0/1
1000	0/1
500	0/1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the conditions of the test, the test substance has not to be classified following EU and the GHS requirements.

Executive summary:

ALD50 was ca. 4900 mg/kg bw.

The test substance was administered via single dose gavage to groups of one or five animals per dose level. Animals were observed approximately 1-3 hours after dosing and then daily over a period of 8 days. At necropsy, all rats were examined for gross pathological changes.

All but one of the animals given 5000 mg/kg bw and more died; late deaths were observed. Lethal doses caused seizures. Sublethal doses led to stiff gait, apathy, reduced appetite, diarrhoea, and rough coat. At necropsy, signs of gastro-intestinal tract irritation and intestinal bleeding were found.