Octamethylenediamine

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: comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BASF-Test

Principles of method if other than guideline:

The fur of 2 rabbits was clipped and an 80% solution of the substance in water was applicated using a soaked test patch (2.5 x 2.5 cm). The patch was applicated onto the back of the animals. After an occlusive exposure period of 1, 5 and 15 minutes as well as 20 hours the application area was washed with Lutrol/water (1:1). Furthermore the ears were wrapped for 20 hours with a patch soaked with a 80% solution of the substance in water. Skin effects were documentated 24 hours and 8 days after the removal of the test patches.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octamethylenediamine

EC Number:

206-764-3

EC Name:

Octamethylenediamine

Cas Number:

373-44-4

Molecular formula:

C8H20N2

IUPAC Name:

octane-1,8-diamine

Details on test material:

- Name of test material (as cited in study report): Oktamethylendiamin
- Physical state: solid

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

Concentration: 80 %

Duration of treatment / exposure:

skin of the back: 1, 5 and 15 minutes, 20 hours
ear: 20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol/water (1/1)
- Time after start of exposure: 1, 5 and 15 minutes, 20 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 1 minute exposure, reading after 24 hours

Score:

1

Reversibility:

not reversible

Remarks on result:

other: severe irritation, marked erythema and slight edema 24 hours after an exposure of 1 minute

Results 2

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 1 minute exposure, reading after 8 days

Score:

2

Reversibility:

other: symptoms on the last day of the study

Remarks on result:

other: marked necrosis and erythema as well as slight edema 8 days after an exposure of 1 minute

Results 3

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 5 minutes exposure, reading after 24 hours

Score:

2

Reversibility:

not reversible

Remarks on result:

other: marked necrosis 24 hours after an exposure of 5 minutes

Results 4

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 5 minutes exposure, reading after 8 days

Score:

2

Reversibility:

other: symptoms on the last day of the study

Remarks on result:

other: marked necrosis 8 days after an exposure of 5 minutes

Results 5

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 15 minutes exposure, reading after 24 hours

Score:

>= 3

Reversibility:

not reversible

Remarks on result:

other: severe necrosis 24 hours after an exposure of 15 minutes

Results 6

Irritation parameter:

other: Necrosis score

Basis:

mean

Time point:

other: 15 minutes exposure, reading after 8 days

Score:

>= 3

Reversibility:

other: symptoms on the last day of the study

Remarks on result:

other: severe necrosis 8 days after an exposure of 15 minutes

Any other information on results incl. tables

The fur of 2 rabbits was clipped and an 80% solution of the substance in water was applicated using a soaked test patch (2.5 x 2.5 cm). The patch was applicated onto the back of the animals. After an occlusive exposure period of 1, 5 and 15 minutes as well as 20 hours the application area was washed with Lutrol/water (1:1). Furthermore the ears were wrapped for 20 hours with a patch soaked with a 80% solution of the substance in water. Skin effects were documentated 24 hours and 8 days after the removal of the test patches.

The severity of substance induced edema, necroses and erythema was quantified for each time point using the following values:

Grading according to BASF-Test for necrosis (N), edema (Ö) and redness (R)	Description	Grading according to OECD 404
Ø	no symptom	0
(+)	questionable	0
+	slight	1
++	marked	2
+++	severe	≥3

N+ is interpreted as sign of severe irritation while N++ or N+++ represents a full thickness necrosis.

The followign results were reported:

Time of exposure	Symptoms after 24 hours	Symptoms after 8 days
1 minute	N+/R++/Ö+	N++/R++/Ö+
5 minutes	N++ (edge: R+ Ö+)	N++ (edge: R++)
15 minutes	N+++ (edge: R++ Ö+)	N+++ (surrounding N+)
20 hours	N+++ (edge: R++ Ö++)	N+++
20 hours (ear)	N+++	mummification

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information

Conclusions:

Classification: corrosive (causes burns)

Executive summary:

The test substance caused full thickness necrosis 24 hours after an occlusive exposure of 5 and 15 minutes which was not reversible within 8 days. Furthermore the occlusive exposure of 1 minute caused slight necrosis and edema as well as marked erythema after 24 hours which were not reversible within 8 days while the necrosis aggravated to a marked one after 8 days.