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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1977

Materials and methods

Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalide
EC Number:
201-744-0
EC Name:
Phthalide
Cas Number:
87-41-2
Molecular formula:
C8H6O2
IUPAC Name:
1(3H)-Isobenzofuranone
Details on test material:
- Name of test material (as cited in study report): Phthalid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 209 g (mean); females: 164 g (mean)
- Diet: Altromin R1324 (Altromin GmbH, Germany), ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 CMC aqueous solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 21.5%, 31.6%, 38.3%, 46.4%, 50%



MAXIMUM DOSE VOLUME APPLIED: 20 ml

Doses:
2150, 3160, 3830, 4640, 5620, 6810, 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of application and daily thereafter
- Frequency weighing: days 0, 3, 7 and 13
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 600 mg/kg bw
Mortality:
10000 mg/kg bw: all animals died within 1 h and 24 h.
6810 mg/kg bw: all animals died within 1 h and 24 h.
5680 mg/kg bw: 2/5 males and 2/5 females died within 24 h.
4640 mg/kg bw: no mortalities.
3830 mg/kg bw: 1/5 males died within 24 h.
3160 mg/kg bw: 2/5 males and 1/5 females died within 24 h.
Clinical signs:
Dyspnoea, apathy, abdominal-lateral position, partially tumbling, atony, narcotic state with unusual pain and corneal reflex, exsiccosis, salivation, bad general condition.
Body weight:
The surviving animals gained normal weight.
Gross pathology:
Animals that died during the study:
Heart: acute dilatation of the right ventricle; acute congestion;

Sacrificed animals: no macroscopic abnormalities at necropsy.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw) gender 24 h 48 h  14 days                
10000 m 5/5 5/5  5/5                
10000 f 5/5 5/5  5/5                
6810 m 5/5 5/5  5/5                
6810 f 5/5 5/5  5/5                
5680 m 2/5 2/5  2/5                
5680 f 2/5 2/5  2/5                
4640 m 0/5 0/5  0/5                
4640 f 0/5 0/5  0/5                
3830 m 1/5 1/5  1/5                
3830 f 0/5 0/5  0/5                
3160 2/5 2/5  2/5                
3160 f 1/5 1/5  1/5                
2150 m 0/5 0/5  0/5                
2150 f 0/5 0/5  0/5                

Applicant's summary and conclusion