2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2002-11-12 to 2002-11-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

EC Number:

607-997-7

Cas Number:

26776-30-7

Molecular formula:

Exact identification is not feasible

IUPAC Name:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

Test material form:

liquid: viscous

Details on test material:

90 % Hexamehylendiisocyanate, oligomeric, caprolactam blocked
10 % Solvesso

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Source: WISTAR strain Crl: (EI) BR , Charles River Deutschland, Sulzfeld
- young adult animals
- Fasting period before study: maximum 20 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 15 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose: 2000 mg/kg/bw (1.83 ml/kg), undiluted
- Dose volume was calculated as dose level: density

Doses:

2000 mg/kg, correlating to 1800 mg/kg (based on active ingredient of test substance)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: periodic intervals on the dayof dosing (day 1) and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: All survived animals were necropsied at the end of the observation period

Statistics:

not required

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 800 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 90 % substance in solvent

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalitiy occurred

Clinical signs:

other: Hunched posture, lethargy, rales, red or brown staining of the skin, salivation, chromodacryorrhoea and ptosis were noted among the animals between days 1 and 4. Alopecia was observed in 3 females between days 11 and 15 and in one male between days 5 and

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:

other: as test item a 90 % solution in solvent naphtha was used; the induced effects might be interpreted as solvent driven

Conclusions:

The oral LD50 value of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in female and male Wistar rats was established to exceed 2000 mg/kg bw for the test substance (> 1800 mg/kg based on active ingredient). No mortalities were observed. Therefore, under the conditions of this study the acute toxicity of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane after oral exposure in rats is low.

Executive summary:

The study for assessment of acute oral toxicity with 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in rats was carried out according to OECD Guideline 423. The test item was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg bw (1800 mg/kg based on active ingredient). Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Hunched posture, lethargy, rales, red or brown staining of the skin, salivation, chromodacryorrhoea and ptosis were noted among the animals between days 1 and 4. Alopecia was observed in 3 females between days 11 and 15 and in one male between days 5 and 15. As test item a 90% solution in solvent naphta was used. The induced effects could be interpreted as solvent driven. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

Therefore the oral LD50 value of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane in Wistar rats was established to exceed 2000 mg/kg bw (> 1800 mg/kg based on active ingredient).