Sebacic acid, compound with hexane-1,6-diamine (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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short observation period; limited documentation; however, basic data are given.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

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)

Deviations:

not specified

Principles of method if other than guideline:

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.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

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

IUPAC Name:

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

Constituent 2

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine

IUPAC Name:

Adipic acid, compound with hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): AH-Salz trocken (hexamethylenediamine adipate, dry)
No further data.
The justification of the read-accross is fully detailed in the endpoint summary.

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

Based on:

test mat.

Mortality:

All but one of the animals given 5000 mg/kg bw and more died; late deaths were observed. See table 7.2.1/1.

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 7.2.1/1: 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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item is not classified for acute oral toxicity in rats as LD50 is higher than 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study (BASF, 1956), groups of 1 to 5 rats were given a single dose of Hexamethylenediamine adipate, dry (purity not given) at doses of 500, 1000, 2000, 4000, 5000, 8000, and 100000 mg/kg bw and were observed for 8 days. Necropsy was performed at the end of the study.

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

Based on this study,the oral LD50 in rats was approximately 4900 mg/kg bw.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC criteria, as for sebacic acid, compound with hexane-1,6 -diamine (1:1), considering the read-accross approach.