3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]

Endpoint summary

Description of key information

Single treatment of rats via oral or dermal routes did not cause any adverse effect.

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

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to guideline and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males: 198 - 207 g; Females: 175 - 182 g
- Fasting period before study:
- Housing: Makrolon type-3 cages in groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least one week under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 40-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light):12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250mg/ml

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

5000 mg/kg bw

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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

No effect

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral treatment of rats with a dose of 5000 mg/kg bw did not cause any adverse effects.

Executive summary:

The test article was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg in PEG 400 at an application volume of 20 ml/kg. Animals were observed for 15 days.

No moratlity was detected at 5000 mg/kg.

No symptoms were observed.

No macroscopic organ changes were observed in survivors at the end of the observation period.

The acute oral LD50 of the test material in rats of both sexes, observed over a period of 15 days, was estimated to be:

greater than 5000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

reliable without restriction

Acute toxicity: via inhalation route

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:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to guideline and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males: 195 - 219 g; Females: 189 - 203 g
- Fasting period before study: no data
- Housing: Makrolon type-2 cages with standard softwood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 40-70%
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: 10 % of body surface
- Type of wrap if used: occlusive

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml (2000 mg/kg)
- Concentration (if solution): 500 mg/ml
- 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,

Statistics:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Local findings at the site of application: erythema, necroses (males only), scales, blue discoloration (testmaterial is blue pigment)

Gross pathology:

no effects

Other findings:

none

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a limit test the material did not cause any signs of systemic toxicity. Severe but transient local effects at the site of application were observed.

Executive summary:

The test article was applied to the skin of rats of both sexes for 24 hours at a dose of 2000 mg/kg.

The following death rate was observed: 0 % at 2000 mg/kg

Therefore, the toxicity of the test material was estimated to be: greater than 2000 mg/kg

SYMPTOMS:

The following local findings were observed: 2000 mg/kg: erythema, necroses (males), scales, application area blue discolored (Test material is a blue pigment). The discoloration of the treated skin was observed until termination of observation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable without restriction

Additional information

Single treatment of rats via oral or dermal routes did not cause any adverse effect. The test material is not classified.

Justification for selection of acute toxicity – oral endpoint
Study according to guideline and GLP

Justification for selection of acute toxicity – dermal endpoint
Study according to guideline and GLP

Justification for classification or non-classification

As no adverse effects were detected in acute oral and dermal studies no classification is warranted.