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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.