Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across, GLP, acc. to Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

see chapter 13

IUPAC Name:

see chapter 13

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 7 -8 weeks
- Weight at study initiation: 210 - 300 g
- Fasting period before study: no
- Housing: single polypropylenen cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 42 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

suspension

Details on dermal exposure:

TEST SITE
- % coverage: ca 10
- Type of wrap if used: impermeable plaster arround the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, but wiped with paper towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4mL/kg of a 500 mg/mL suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: daily observation; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

none

Clinical signs:

other: No abnormal observations

Gross pathology:

No abnormal observations

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of Brown HH 469 in rats with intact skin was in excess of 2000 mg/kg.

Executive summary:

A study was performed te determine the acute dermal median lethal dose (LD50) of Brown HH 469 in the rat. The study was designed to meet the requirements of Annex V of the EEC Council Directive 79/831/EEC, the Organisation for Economic Co-operation and Developement (OECD), and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

A group of 10 Sprague-Dawley rats (5 males, 5 females) was given a single, 24 hour, dermal application of Brown HH 469 at a dose level of 2000 mg/kg.

No animals died during the 14 day observation period. The acute dermal median lethal dose (LD50) of Brown HH 469 was in excess of 2000 mg/kg.