Nitriles, C16-18 and C18-unsatd.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable study performed according to guideline and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C16-18 evennumbered, C18 unsaturated alkyl nitrile

EC Number:

629-695-4

Cas Number:

164383-22-6

Molecular formula:

No molecular formula

IUPAC Name:

C16-18 evennumbered, C18 unsaturated alkyl nitrile

Details on test material:

Appearance: light brown, viscous liquid
Name: Arneel T or tallow nitrile

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands,
- Age at study initiation: young
- Weight at study initiation: 2500-3500g
- Housing: individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): at least 40
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: The test was started on February 24, 1986 and completed on February 25, 1986.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading) 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

IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection,
any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis: lids and/or nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4


TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h

Score:

0.25

Max. score:

1

Results 6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

After one hour, the eye effects observed in all (three) rabbits consisted of slight redness of the conjunctivae with slight swelling in two animals. After 24 hours, all eye effects had cleared completely.

Any other information on results incl. tables

Rabbit No	Cornea opacity	Iris	conjunctivae
after 1 hour			redness	chemosis
3593	0	0	1	0
3601	0	0	1	0
3606	0	0	1	0
after 24 hours
3593	0	0	0	0
3601	0	0	0	0
3606	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

On the basis of the results obtained it is concluded that the undiluted test substance Arneel T is not an eye irritant and not corrosive to the eyes.

Executive summary:

According to OECD 405 and EC B.5 an eye irritation was performed in New Zealand white rabbits. 0.1 ml of the undiluted test substance was instilled in one eye of each animal and the animals were observed after 1 and 24 hours. The test substance caused slight eye effects in all (three) rabbits. After 24 hours, all eye effects had cleared completely.On the basis of the results obtained it is concluded that the undiluted test substance Arneel T is not an eye irritant and not corrosive to the eyes.