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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
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

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-diaminostilbene-2,2'-disulphonate
EC Number:
230-847-3
EC Name:
Disodium 4,4'-diaminostilbene-2,2'-disulphonate
Cas Number:
7336-20-1
Molecular formula:
C14H14N2O6S2.2Na
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonate)
Details on test material:
- Name of test material (as cited in study report): 2,2'-Diaminostilbene-4,4'-disulfonsäure Di-Na-Salz
- 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.: 91/099
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranteed
- 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: 3.3 - 3.4kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): stamdard, once per day 100-120g in the morning
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 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): 55 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
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-24 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is considered not irritant to the eyes.