Octamethylenediamine

Eye irritation

Administrative data

Endpoint:

eye 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:

50 mm3 of the test substance were introduced into the lower conjunctival sac of 2 rabbits' right eyes. The left eyes were used as control and treated with talcum powder. The eyes were not washed after the application. The animals were observed for 8 days with readings after 1 hour, 24 hours and 8 days.

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 / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

unchanged

Duration of treatment / exposure:

8 days

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hour

Score:

>= 3

Reversibility:

not reversible

Remarks on result:

other: corrosion after an exposure of 1 hour, not reversible within 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

>= 3

Reversibility:

not reversible

Remarks on result:

other: corrosion after an exposure of 24 hours, not reversible within 8 days

Any other information on results incl. tables

50 mm3 of the test substance were introduced into the lower conjunctival sac of 2 rabbits' right eyes. The left eyes were used as control and treated with talcum powder. The eyes were not washed after the application. The animals were observed for 8 days with readings after 1 hour, 24 hours and 8 days while the effects were graded as follows:

Grading according to BASF-Test for necrosis (N), redness (R) and opacity (Tr)	Description	Grading according to OECD 405
Ø	no symptom	0
(+)	questionable	0
+	slight	1
++	marked	2
+++	severe	≥3

Iritis + or ++ = Iritis grade 1 or 2

The following symptoms were reported:

Time of exposure	Symptoms of treated eyes	Symptoms of control eyes
1 hour	corrosion	R+
24 hours	corrosion	Ø
8 days	corrosion, crusts	Ø

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information corrosive

Conclusions:

Classification: irreversible effects on the eyes

Executive summary:

50 mm3 of the test substance were introduced into the lower conjunctival sac of 2 rabbits' right eyes. The left eyes were used as control and treated with talcum powder. The eyes were not washed after the application. The animals were observed for 8 days with readings after 1 hour, 24 hours and 8 days. After an exposure of 1 hour the eyes treated with the test substance showed eye corrosion which was not reversible within 8 days. The control eyes showed slight redness after 1 hour of treatment which was fully reversible within 24 hours.