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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study. However, test material purity was not listed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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)

Details on test material:

- Name of test material (as cited in study report): 2,2'-Diaminostilbene-4,4'-disulfonsäure
- Substance type: organic
- Physical state: powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: P 2081 VM
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton Huntington; England
- Age at study initiation: no data
- Weight at study initiation: 3.4 - 4kg
- Housing: individually in stainless steel cages
- Diet: standard, once per day 100-120g in the morning
- Water: ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 °C
- Humidity (%): 40-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 39 mg

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

other: no details available

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: no details available

Results 2

Irritation parameter:

cornea opacity score

Basis:

other: no details available

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: no details available

Results 3

Irritation parameter:

chemosis score

Basis:

other: no detials available

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: not specified

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

> 0.3 - <= 0.7

Max. score:

0.7

Reversibility:

fully reversible within: 48h

Remarks on result:

other: no further details available

Applicant's summary and conclusion

Interpretation of results:

other: non irritating

Conclusions:

The substance is considered not irritant to the eyes.

Executive summary:

The eye irritation potential of the test substance was evaluated in an experiemntal study performed according to OECD Guideline 405. Based on the obtained results the test substance is considered as non irritant to the eyes.