C.I. Reactive Blue 224

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1985-Aug-20 to 1985-Sep-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to EC guideline 84/449, which is similar to OECD 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EC-directive 84/449 (L251,96)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reactive Blue FC 15353

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, SPF breeding colony
- Age at study initiation: 9 weeks (male) to 14 weeks (female)
- Weight at study initiation: 180 g (male), 184 g (female)
- Housing: macrolon cages (type III) on wood granulate, in groups of 5 animals/cage
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 50±10 %
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10% skin surface
- Type of wrap if used: aluminum foil and fixed with non-irritating plaster

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg body weight
- For solids, paste formed: yes - using water

Duration of exposure:

24 h

Doses:

5 ml/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms recorded twice every day (once on weekends and public holidays); animals were weighed weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No symptoms were observed.

Gross pathology:

No gross pathological changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median LD50 of Reactive Blue FC 15353 for mals and female Wistar rats is >2500 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study, Wistar rats, 5/sex, were dermally exposed to Reactive Blue FC 15353 in deionized water for 24 hours to 10 % of body surface area at a dose of 2500 mg/kg body weight. Animals then were observed for 14 days. No mortality or clinical signs were observed after administration.

Dermal LD50:

Males = >2500 mg/kg body weight

Females = >2500 mg/kg body weight

Combined = >2500 mg/kg body weight

Reactive Blue FC 15353 is of LOW Toxicity based on LD50 > 2500 mg/kg body weight.