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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 105 - 128 g
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
1 % aqueous methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % (w/v)
- Amount of vehicle: 20 mL/kg

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: twice daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths following a single oral dose of the test substance at 5000 mg/kg bw.
Clinical signs:
other: No clinical signs were observed up to the highest tested concentration.
Gross pathology:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute LD50 oral to rats of the test substance was found to be greater than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study according to OECD guideline 401, groups of fasted Sprague Dawley rats (5/sex) were given a single oral dose of the test substance in water at a limit dose of 5000 mg/kg bw. Animals were treated by gavage and were then observed for 14 days.

No mortality or clinical signs were observed. All rats achieved anticipated bodyweight gains throughout the study. No abnormal findings were observed during necropsy.

An LD50 of above 5000 mg/kg bw was determined for male and female animals.