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

Endpoint summary

Description of key information

Oral gavage of 5000 mg/kg of the test material did not cause mortality in male and female rats. There were temporary clinical signs.
The acute dermal median lethal dose (LD50) of the analogous substance in rats with intact skin was in excess of 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no GLP; short report

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd. Margate UK
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 70 to 90 g
- Fasting period before study: 21 h
- Housing: no data
- Diet (e.g. ad libitum): ad ibitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 C
- Humidity (%): ca 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 %
- Justification for choice of vehicle: Water is the vehicle of joice whenever possible.

MAXIMUM DOSE VOLUME APPLIED: 12.5 ml/kg

Doses:

0 mg/kg bw ( Control)
5000 mg/kg bw (treated)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency ofweighings: days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Mortality:

None

Clinical signs:

other: Piloerection, hunched posture, and abnormal gait (waddling) occurred shortly after dosing. Piloerection was abserved also in the control group.

Gross pathology:

No abnormal findings

Other findings:

none.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats.

Executive summary:

The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats. Clinical signs were limited to temporary piloerection hunched posture and abnormal gait shortly after treatment. No adverse effects on body weights or the macroscopic appearance of organs were detected.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch grade : 2, no GLP (predates GLP), method similar to standard method of the time

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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,

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch grade : 2, no GLP (predates GLP), method similar to standard method of the time

Additional information

Neither oral nor dermal application of the test item to rats at the highest recommended doses caused mortality. Slight, temporary clinical signs were observed only after oral gavage.

Justification for selection of acute toxicity – oral endpoint
target substance tested

Justification for selection of acute toxicity – dermal endpoint
sole study

Justification for classification or non-classification

Not classified. There is no need for classification for acute toxicity because mortality, the relevant criterion, was not observed.