2,5-dianilinoterephthalic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

2,5-dianilinoterephthalic acid

EC Number:

233-302-8

EC Name:

2,5-dianilinoterephthalic acid

Cas Number:

10109-95-2

Molecular formula:

C20H16N2O4

IUPAC Name:

2,5-bis(phenylamino)benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Anilosäure (Dianiloterephthalsäure, 2,5-Dianiloterephthalsäure)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Hoechst AG breed colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.7 kg to 3.3 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of each rabbit served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the undiluted (unchanged) test substance

Duration of treatment / exposure:

Treatment: Single application
Exposure: 24 h, at the end of the exposure period eyes were rinsed with physiol. saline

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place


TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 59, 60, 100 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (cornea) at any time

Results 2

Irritation parameter:

iris score

Basis:

animal: # 59, 60, 100 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: no signs of irritation (iris) at any time

Results 3

Irritation parameter:

chemosis score

Basis:

animal: # 59, 60, 100 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (chemosis) at any time

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 59, 60, 100 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: initial slight effects were fully reversible within 24 h

Other effects:

Violet discharge was observed at 1 hour after application

Any other information on results incl. tables

Animal no	Sex	Evaluation Interval	Cornea	Conjunctiva			Iris
			Opacity	Redness	Chemosis	Discharge
59	F	1 h	0	1	0	1	0
60			0	1	0	1	0
100			0	1	0	1	0
59	F	24 h	0	0	0	0	0
60			0	0	0	0	0
100			0	0	0	0	0
59	F	48 h	0	0	0	0	0
60			0	0	0	0	0
100			0	0	0	0	0
59	F	72 h	0	0	0	0	0
60			0	0	0	0	0
100			0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

not irritating to the eye

Executive summary:

A study with the test item according to OECD Guideline 405 was performed to investigate the irritation potential to the rabbit eye.

One hour after treatment the conjunctivae of the animals showed definitely injected blood vessels. Additionally substance coloured eye discharge was observed in the animals one hour after treatment. 24 hours after treatment all signs of irritation were reversible.

Testing of Anilosäure for primary eye irritation in the rabbit showed that the substance is not irritating to the eye.