pentasodium 4-hydroxy-7-[(sulfonatomethyl)amino]-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-8-[(2-sulfonato-4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jun. 06, 2002 to Sep. 18, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to EU Method B.3. OECD Guideline 402 and OPPTS 870.1200 in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 wk
- Weight at study initiation: 228± 5 g (males); 2036± 11.3 g (females)
- Housing: Transparent macroIon cages (type 3) on soft wood granulate, 1 animal per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Jun. 06, 2002 To: Jun. 20, 2002

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal skin of the area (30 cm2)
- Type of wrap if used: Elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of test substance was moistened with 0.28 mL sesame oil.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.28 mL sesame oil.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: Clinical signs and body weight

Statistics:

No 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.

Remarks on result:

other: -

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: From Day 2 of the study up to Day 5 (male group) and up to Day 7 (female group) a slight erythema of the skin was observed.

Gross pathology:

No gross pathological changes were observed

Other findings:

No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.

Executive summary:

A study was conducted to assess the acute dermal toxicity of test substance in Sprague-Dawley CD rats according EU Method B.3., OECD guideline 402 and OPPTS 870.1200 in compliance with GLP.

Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.28 mL sesame oil, at a dose level of 2,000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination.

No mortality was observed in the study. From Day 2 of the study up to Day 5 (male group) and up to Day 7 (female group) a slight erythema of the skin was observed. The overall body weight gain was not impaired in both sexes. The animals killed at the end of the observation period showed no macroscopically visible changes.

 

Under the test conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.