Reaction product of 2-[bis(cyanomethyl)amino]-propanenitrile and sodium hydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

according to Fed. Reg. 38, No. 187, & 1500.42, 1973 (Draize test) and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, 1959

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydroxide

EC Number:

215-185-5

EC Name:

Sodium hydroxide

Cas Number:

1310-73-2

Molecular formula:

HNaO

IUPAC Name:

sodium hydroxide

Details on test material:

Name of test material (as cited in study report): Natronlauge

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: M. Gaukler, 6050 Offenbach
- Weight at study initiation: ca. 2.9 kg
- Diet (e.g. ad libitum): Ssniff K, Standard diet for rabbits and guinea pigs of the company INTERMAST GMBH, Soest.
- Water (e.g. ad libitum): Ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

100 ul

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 (sodium hydroxide 0.95%) + 3 (sodium hydroxide 4.9%)

Details on study design:

Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.

SCORING SYSTEM:
Draize scoring system for eye irritation:

Cornea
A. Opacity: degree of density (readings should be taken from most dense area): the area of corneal opacity should be noted
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than one-half: 2
- Greater than one-half but less than three quarters: 3
- Greater than three quarters up to whole area: 4
Score equals AxBx5 - Total maximum = 80

Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, hemorrhage; gross destruction (any one or all of these): 2
Score equals Ax 5 - Total possible maximum = 10

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
- Normal: 0
- Some blood vessels hyperemic (injected): 1
- Diffuse, crimson color, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis-Swelling (refers to lids and/or nictating membranes)
- Normal: 0
- Some swelling above normal: 1
- Obvious swelling, with partial eversion of lids: 2
- Swelling, with lids about half closed: 3
- Swelling, with lids about half closed to completely closed: 4
C. Discharge
- Normal: 0
- Any amount different from normal (does not include small amount observed in inner canthus of normal rabbits): 1
- Discharge with moistening of the lids and hairs just adjacent to the lids: 2
- Discharge with moistening of the lids and considerable area around the eye: 3
Score equals (A+B+C) x 2 - Total maximum = 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 0.95%

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.89

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: sodium hydroxide 0.95%

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 0.95%

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.22

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: sodium hydroxide 0.95%

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.25

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 4.9%

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 4.9%

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.63

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 4.9%

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.33

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: sodium hydroxide 4.9%