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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

403-830-5

EC Name:

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

Cas Number:

89331-94-2

Molecular formula:

C35H36N2O3

IUPAC Name:

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl;CD(SD)BR]

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 205 - 231 g
- Housing: individually in metal cages
- Diet: Standard laboratory rodent diet (Labsure LAD 1), ad libitum
- Water: ad libitum
- Acclimation period: at least 16 days

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 x 50 mm
- % coverage: ~10
- Type of wrap: gauze which was held in place with an impermeable dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: with warm (30 - 40 ºC) water and blotting dry with absorbent paper
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 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: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation including the nature, severity , approximate time of onset and duration of each toxic sign. Individual bodyweights of rats on Days 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: Yes, all animals on the study were sacrificed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavity. The macroscopic appearance of abnormal organs when present was recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred at the 2000 mg/kg dose level.

Clinical signs:

other: There were no clinical signs observed. Furthermore, application of the test substance caused no irritation reactions or other dermal changes at the treatment sites.

Gross pathology:

No macroscopic abnormalities were found during necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute LD50 value for rats was found to be greater than 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study according to OECD guideline 403 (Huntingdon, 1988), groups of young (7 - 10 weeks) Sprague Dawley rats (5/sex)were dermally exposed to the test substance for 24 hours to 10 % of body surface area at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days.

No mortality or clinical signs were observed. Application of the test substance did not cause any irritation reactions or other dermal changes at the treatment site. Body weight gain was normal throughout the study period. No macroscopic abnormalities were found during necropsy.

An LD50 of above 2000 mg/kg bw was determined for male and female rats.