N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

EC Number:

210-043-9

EC Name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

Cas Number:

603-48-5

Molecular formula:

C25H31N3

IUPAC Name:

4-{bis[4-(dimethylamino)phenyl]methyl}-N,N-dimethylaniline

Test material form:

solid

Details on test material:

- Purity: not reported

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: not reported
- Weight at study initiation: Female # 1, 2.83 kg; Female # 2, 2.85 kg; Male # 1, 3.14 kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: about 130 g per animal per day
- Water (e.g. ad libitum): About 250 mL tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod: 12 hours light (06:00 to 18:00) and 12 hours dark (18:00 to 06:00)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and served as the control

Amount / concentration applied:

0.1 mL (~ 28 mg)

Duration of treatment / exposure:

Single application

Observation period (in vivo):

1, 24, 48, and 72 hours after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: The substance was not washed out

SCORING SYSTEM:
- Chemosis and Corneal Opacity: 0 = none; 1= slight; 2= well-defined; 3= severe; 4= very severe
- Area of cornea involved: 1= >0 but <1/4; 2= ≥1/4, but <1/2; 3 = ≥1/2 but <3/4; 4 = ≥ 3/4
- Conjunctivae redness: 0 = normal; 1= slight; 2 = well-defined; 3 = severe
- Discharge: 0 = normal; 1 = slightly increased; 2 = clearly increased; 3 = distinctly increased
- Iris: 0 = normal; 1 = circum-corneal injection; 3 = iritis
- Calculation of the mean according to 83/467/EEC criteria of July 29th 1983 (for calculation of the means of opacity, iris, redness, and swelling only the readings of 24, 48, and 72 hours were used)

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

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

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

other: Discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Well-defined conjunctival irritation (score of 2) was observed in all animals 1 hour after instillation. At 24 hours, one animal exhibited slight conjunctival irritation (score of 1). No oedema, chemosis, discharge, or iritic effects were observed.

Any other information on results incl. tables

Results acute eye irritation

 

Readings	Animal #	Corneal Opacity	Iris	Conjunctival Redness	Discharge	Chemosis
1 hour	1 2 3	0 0 0	0 0 0	2 2 2	0 0 0	0 0 0
24 hours	1 2 3	0 0 0	0 0 0	1 0 0	0 0 0	0 0 0
48 hours	1 2 3	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
72 hours	1 2 3	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Mean	1 2 3	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
Group Mean		0.0	0.0	0.1	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

At 24 hours, one animal exhibited slight conjunctival irritation (score of 1). No oedema, chemosis, discharge, or iritic effects were observed.

Executive summary:

The test substance was instilled into the conjunctival sac of the right eyelid of 3 rabbits. The left eye was untreated and served as the control. The test substance was not washed out. Examinations were made at 1 hour after instillation and then at 24, 48, and 72 hours after instillation.

 

The test substance produced well defined conjunctival redness when examined one hour after instillation. The redness was reduced in the eye of one rabbit when examined at 24 hours while the other 2 eyes were clear of the redness. No chemosis, discharge, or corneal or iritic effects were observed at any of the examination timepoints.