6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one

Endpoint summary

Description of key information

The acute lethal oral dose to rats of ODB-2 was found to be: greater than 5.0 g / kg bodyweight

The acute lethal dermal dose to rats of ODB-2 was found to be: greater than 2.0 g / kg bodyweight.

The study shows that 2% by mass of particles are < 10µm, therefore the vast majority of the particles are non-inhalable and an acute inhalation study is not warranted.  Furthermore, about 40% > 100 µm, this is accepted as a completely non-respirable fraction.

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:

17 February to 02 March 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory rat supplier
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 105 to 128 g
- Fasting period before study:
- Housing: Metal cage with wire mesh floor
- Diet: Standard laboratory rodent diet, Labsure LAD , ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 22°C
- Humidity: 48%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v
- Amount of vehicle (if gavage): 1% aqueous CMC

MAXIMUM DOSE VOLUME APPLIED: 5.0 g / kg bw

Doses:

5.0 g / kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily, bodyweights at days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology.

Preliminary study:

None

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by Day 2.

Gross pathology:

Terminal autopsy findings were normal.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal oral dose to rats of ODB-2 was found to be: greater than 5.0 g/kg bodyweight

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch 1

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:

05 to 19 February 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory rat supplier.
- Age at study initiation: Seven to 10 weeks.
- Weight at study initiation: 205 to 231 g
- Fasting period before study: no
- Housing: Metal cages with mesh floors.
- Diet: standard laboratory rodent diet, Labsure LAD 1, ad libitum.
- Water: ad libitum
- Acclimation period: At least 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22°C
- Humidity (%): 46%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.

Type of coverage:

occlusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10%
- Type of wrap if used: Gauze held in place with impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Washed with warm water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.5 ml / kg
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24 hours

Doses:

2.0 g / kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No macroscopic abnormalities were found during the autopsy procedure.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose to rats of ODB-2 was found to be: greater than 2.0 g / kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1

Additional information

Justification for selection of acute toxicity – oral endpoint

Only study available

Justification for classification or non-classification

The oral and dermal studies return LD50's of 5.0 and 2.0 g / kg bw and the inhalation study is waived on grounds of particle size. Therefore, the substance is not classified for acute toxicity.