N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-08-18 to 1987-10-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

EC Number:

255-473-8

EC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Cas Number:

41642-51-7

Molecular formula:

C20H19N7O3

IUPAC Name:

N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Test material form:

solid: crystalline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: Young adult
- Housing: one animal per cage (standard cage type III)
- Diet (e.g. ad libitum): ad libitum (ssniff K 4, Versuchtierdiäten GmbH, Soest/Westfalen, Germany)
- Water (e.g. ad libitum) ad libitum (tap water)
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): ca. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

single treatment, 24 h after instillation the treated eye was washed with physiological saline

Observation period (in vivo):

Scoring was conducted after 1, 24, 48, 72 hours and 7 days after treatment

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on material and methods incl. tables")

TOOL USED TO ASSESS SCORE: optical tools and fluorescin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No indication of irritation have been observed. Detailed results are provided in table 2 (see box "Any other information on results incl. tables")

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

	24 hours				48 hours				72 hours				Mean 24/48/72 hours
Animal No.	Cornea opacity	Iris	Conjunctivae	Chemosis	Cornea opacity	Iris	Conjunctivae	Chemosis	Cornea opacity	Iris	Conjunctivae	Chemosis	Cornea opacity	Iris	Conjunctivae	Chemosis
1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute eye irritation/corrosion study in rabbits, the test item was tested negative regarding irritation to the eye. The substance is not classifiable according to CLP criteria.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of the test item was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits (three males) for 24 hours. Afterwards the treated eye was washed with physiological saline. Animals then were observed for 7 days. Irritation was scored by the method of Draize. In this study, the test item is not an eye irritant based on the results obtained in this study.