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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive, 24 hour treatment
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
237-600-9
EC Name:
Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
13863-31-5
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Details on test material:
- Analytical purity: > 80%

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2.0 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after initiation of treatment
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: impermeable material


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Skin Irritation Score:

 

 

intact skin

abraded skin

animal no. / sex

time after application

erythema

edema

erythema

edema

1/m

24 h

0

0

2

0

2/m

1

0

2

2

3/m

0

0

1

1

4/f

1

0

2

1

5/f

1

1

2

1

6/f

1

1

2

2

1/m

72 h

0

0

0

0

2/m

0

0

1

1

3/m

0

0

1

0

4/f

0

0

1

0

5/f

0

0

0

0

6/f

0

0

1

0

1/m

mean 24 - 72 h

0

0

1

0

2/m

0.5

0

1.5

1.5

3/m

0

0

1

0.5

4/f

0.5

0

1.5

0.5

5/f

0.5

0.5

1

0.5

6/f

0.5

0.5

1.5

1

 

mean 24 - 72 h

0.3

0.2

1.3

0.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU