1,4-diazabicyclooctane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study pre-dates GLPs Test material purity was not documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.41 - Federal Hazardous Substances A c t Regulations - 16 CFR - Po 124.

Principles of method if other than guideline:

Draize Test
A group of six albino rabbits was clipped over a wide area. One side of the animals' backs was abraded a t one site with a
lancet sufficiently deep to penetrate the stratum corneum but not enter the derma t o produce bleeding. The skin of the
other side was allowed to remain intact.
A 0.5 gm portion of material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then
placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the
patches in place.
The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were
also made after seventy-two hours. The Draize method of scoring was employed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-diazabicyclooctane

EC Number:

205-999-9

EC Name:

1,4-diazabicyclooctane

Cas Number:

280-57-9

Molecular formula:

C6H12N2

IUPAC Name:

1,4-diazabicyclooctane

Test material form:

solid: crystalline

Details on test material:

IUCLID4 Test substance: as prescribed by 1.1 - 1.4Dabco lot # 80-D-8

Test animals

Species:

rabbit

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped+abradded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period:

72 h

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h and 72h

Score:

2.92

Reversibility:

not specified

Remarks on result:

other: Study was done before OECD guidelines were established, hence there are no 48 h data available.

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

intact skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

intact skin

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

abraded skin

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

intact skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other:

Remarks:

erythema and eschar formation

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

intact skin

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

abraded skin

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

intact skin

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 12

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 13

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

abraded skin

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 14

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 15

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

intact skin

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 16

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 17

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

abraded skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 18

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

intact skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 19

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

intact skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 20

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 21

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

abraded skin

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 22

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 23

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 24

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 25

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

abraded skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 26

Irritation parameter:

erythema score

Basis:

animal: all animals

Remarks:

intactact and abraded skin average subtotal

Time point:

24/48/72 h

Score:

6.51

Reversibility:

not specified

Remarks on result:

other: erythema and eschar formation

Results 27

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

intact skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Results 28

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

intact skin

Time point:

72 h

Score:

3

Reversibility:

not specified

Results 29

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Results 30

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

abraded skin

Time point:

72 h

Score:

3

Reversibility:

not specified

Results 31

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 32

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

intact skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 33

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 34

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

abraded skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 35

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 36

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

intact skin

Time point:

72 h

Score:

0

Reversibility:

not specified

Results 37

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 38

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

abraded skin

Time point:

72 h

Score:

2

Reversibility:

not specified

Results 39

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 40

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

intact skin

Time point:

72 h

Score:

0

Reversibility:

not specified

Results 41

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

abraded skin

Time point:

24 h

Score:

2

Reversibility:

not specified

Results 42

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

abraded skin

Time point:

72 h

Score:

2

Reversibility:

not specified

Results 43

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 44

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

intact skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 45

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 46

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

abraded skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 47

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

intact skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 48

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

intact skin

Time point:

72 h

Score:

0

Reversibility:

not specified

Results 49

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

abraded skin

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 50

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

abraded skin

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 51

Irritation parameter:

edema score

Remarks:

subtotal

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

5.16

Reversibility:

not specified

Remarks on result:

other: Study was done before OECD guidelines were established, hence there are no 48 h data available.

Results 52

Irritation parameter:

other: erythema and eschar formation

Remarks:

subtotal

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

6.51

Reversibility:

not specified

Remarks on result:

other: Study was done before OECD guidelines were established, hence there are no 48 h data available.

Results 53

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 54

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 55

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 56

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 57

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 58

Irritation parameter:

edema score

Basis:

animal #6

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 59

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 60

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 61

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 62

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 63

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 64

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Any other information on results incl. tables

Barely perceptible to severe erythema and barely perceptible
to moderate edema were observed.  A primary irritation index
of 2.92 was calculated.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The material is i r r i t a t i n g t o the skin of albino rabbits.