4,4'-diaminostilbene-2,2'-disulphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source.

Data source

Reference

Reference Type:

other: secondary source

Title:

Eye Irritation study for the test chemical

Author:

USEPA

Year:

2019

Bibliographic source:

High Production Volume Information System (HPVIS)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Eye irritation study was conducted for the given test chemical.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-diaminostilbene-2,2'-disulphonic acid

EC Number:

201-325-2

EC Name:

4,4'-diaminostilbene-2,2'-disulphonic acid

Cas Number:

81-11-8

Molecular formula:

C14H14N2O6S2

IUPAC Name:

2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonic acid)

Test material form:

solid

Details on test material:

- IUPAC Name: 4,4'-diaminostilbene-2,2'-disulphonic acid
- Mol. formula: C14H14N2O6S2
- Molecular Weight: 370.405 g/mole
- InChI: InChI=1S/C14H14N2O6S2/c15-11-5-3-9(13(7-11)23(17,18)19)1-2-10-4-6-12(16)8-14(10)24(20,21)22/h1-8H,15-16H2, (H,17,18,19)(H,20,21,22)/b2-1+
- Smiles: Nc1ccc(\C=C\c2ccc(N)cc2S(=O)(=O)O)c(c1)S(=O)(=O)O

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: healthy, adult, nulliparous, nonpregnant, female rabbits
- Weight at study initiation: weighing 2.9, 3.4 and 3.4 kg were used in the study.
- Housing: Rabbits were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Animals were fed 100-120 g standard diet per animal/day
- Water (e.g. ad libitum): allowed free access to tap water
- Acclimation period: They were quarantined for at least 14 days before use.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 degrees C
- Humidity (%): 40-70% relative humidity
- Air changes (per hr): 12-15 air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle 500 lux illumination

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

39 mg

Duration of treatment / exposure:

24 Hours

Observation period (in vivo):

7 Days

Number of animals or in vitro replicates:

Total = 3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with normal saline 24 hours after treatment
- Time after start of exposure: 24 hours

SCORING SYSTEM: Eye irritation was scored and recorded at 1, 24, 48, and 72 hours and 7 days. The signs of cornea (opacity and area affected), iris (hyperemia, reaction to light), conjunctivae (erythema, chemosis), and discharge were recorded as described by Draize.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

1

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: Discharge scores

Basis:

mean

Time point:

other: 1 h

Score:

1

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: Swelling scores

Basis:

mean

Time point:

other: 1 h

Score:

1

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: Not Irritating

Conclusions:

The given test chemical was Not Irritating to rabbits' eyes.

Executive summary:

Eye irritation study was conducted for the given test chemical as per OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 2.9, 3.4 and 3.4 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. The lower lid was gently pulled away from the eyeball and a volume of 100 microliters of pulverized test material (approximately 39 mg) was placed into the conjunctival sac of one eye of each of the rabbits. The lids were then gently held together for about 1 second. The other eye remained untreated and served as the control. The treated eye was rinsed with normal saline 24 hours after treatment. Eye irritation was scored and recorded at 1, 24, 48, and 72 hours and 7 days. The signs of cornea (opacity and area affected), iris (hyperemia, reaction to light), conjunctivae (erythema, chemosis), and discharge were recorded as described by Draize. Any serious lesions or toxic effects other than ocular were recorded. Examinations of the cornea, iris and aqueous humor were facilitated using optical instruments (e.g. hand slit lamp). To define epithelial dam age, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after treatment. The eye was then rinsed with normal saline. The eyes were examined under UV light in a darkened room and under diffuse white illumination according to the method of McDonald and Shadduck. This procedure was repeated later if positive effects were noted. Only effects persisting for more than 24 hours were included in the evaluation. The irritation indices/mean irritation indices were calculated for cornea (opacity), iris, and erythema and swelling (chemosis) of the conjunctivae. The interpretation was based on the individual indices obtained from the two most sensitive animals. Conjunctival redness scores of 1 (some blood vessels definitely hyperemic) were observed at 1 and 24 hours in all rabbits and also at 48 hours in one rabbit. Discharge scores of 1 (slightly increased) were observed in 2 rabbits at 1 hour. Swelling scores of 1 (swelling slightly above normal, including nictitating membrane) were observed in 2 rabbits at 1 hour. All other scores were 0. The given test chemical was Not Irritating to rabbits' eyes.