Reactive Orange 16

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: read across from supporting substance

Adequacy of study:

key study

Study period:

From July 15,1985 to July 29 ,1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guideline

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:

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 (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 1

IUPAC Name:

Similar substance 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:male 7 weeks old , females 10 weeks old
- Weight at study initiation:male 184-200 g , female 189-219
- Fasting period before study:
- Housing: individually housed in air-conditioned rooms in Makrolon cages (type 3) on softwood pellets
- Diet : altromin 1324, ad libitum
- Water : tap water in plastic bottle, ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±°C
- Humidity (%):50 ± 20%
- Air changes (per hr):fully air condition
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure:30 cm^2
- % coverage: 6 x 8 cm
- Type of wrap if used:
aluminum-foil (6 x 8 cm) and one elastic. The elastic is used to fix around the body of the animal the aluminium foil (Elastoplast, 8 cm).

REMOVAL OF TEST SUBSTANCE
- Washing :yes

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Reactive Orange 64 258 FW F-ratio was 1.0 g + 0.50 ml moistened with isotonic saline solution (sterile, pyrogen-free, supplied by Fresenius AG).
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals x sex x dose

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:every weeks
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 714 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality observed

Clinical signs:

other: no clinical signs observed

Gross pathology:

no pathology observed

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality, irritation or any clinical signs observed during study. LD0= 2000 mg/kg bw (1714 mg/kg based on active ingredient)

Executive summary:

The similar substance 1 was examined for acute dermal toxicity in Wistar rat male and female a lethal dose media (LD50) of 2000 mg / kg body 1714 based on activ ingredient weight. After administration of 2000 mg / kg bw no deaths or related symptoms are observed.