Reaction mass of tetrasodium 5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl) diazenyl]naphthalene-2,7-disulfonate and trisodium 5-({4-chloro-6-[4-(vinylsulfonyl) anilino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 November to 16 November 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-900-0

EC Name:

-

Cas Number:

111211-40-6

Molecular formula:

C29H22ClN7Na4O19S6

IUPAC Name:

tetrasodium 5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino) -1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl) diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv-Rot F-66813 FW

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: males: 203 to 214 g; females: 189 to 198 g
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water: tap water in plastic bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2. Nov To: 16. Nov 1989

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

1 g test compound moistened with 0.8 ml 0.9% NaCl-solution was applied to a shaved skin area of approximately 30 cm2

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: twice daily - on weekends or public holidays: once daily
- Body weight: weekly
- Necropsy of survivors performed: yes

Prior dermal treatment the fur was removed mechanically from the dorsal skin of the animals over an area of approximately 30 cm2.

The adequate amount of Reaktiv-Rot F-66813 FW was pasted and evenly spread on sheets (size 6x8 cm) of aluminium foil. Afterwards the foil covered with test compound was applied to the shaved and intact dorsal skin and fixed with an elastic plaster bandage (Fixomull and Elastoplast, width 8 cm, Beiersdorf AG) wrapped around the animal's body.

After the end of the 24 hours dermal exposure period the bandage was removed and the treated skin area rinsed with lukewarm water to wash off any non-absorbed remnants of the test compound.

The observation period after treatment was 14 days. Clinical symptoms were recorded twice daily (morning and afternoon), on weekends and public holidays only once a day. Body weight development was determined weekly. At the end of the observation period the animals were killed by CO2 asphyxiation, dissected and examined for macroscopically visible changes.

Statistics:

mean and standard deviation of body weight data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Deaths occured.

Clinical signs:

other: No clinical signs were observed in male and female rats during the whole course of study. Only the surface of the skin was red discolored to a smaller or larger extend.

Gross pathology:

No macroscopically visible changes were observed in all animals killed at end of the observation period.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study, the dermal median lethal dose value (LD50) of Reaktiv-Rot F-66 813 FW for the male and female rat is greater than 2000 mg/kg bw.

Executive summary:

Acute dermal toxicity testing of Reaktiv-Rot F-66 813 FW in the rat yielded a dermal median lethal dose (LD50) above 2000 mg/kg bw in both male and female rats. After administration of 2000 mg/kg bw neither deaths nor clinical signs occurred. Only the surface of the skin was red discolored to a smaller or larger extend. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.

Based on the results obtained in this study, the dermal median lethal dose value (LD50) of Reaktiv-Rot F-66 813 FW for the male and female rat is greater than 2000 mg/kg bw.

Hence, Reaktiv-Rot F-66 813 FW is not classified.