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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available

Data source

Reference
Reference Type:
publication
Title:
Studies on the toxicity of rabcide (phthalide). On the acute and chronic toxicity of phthalide to rat and mouse.
Author:
Abe E. et al.
Year:
1974
Bibliographic source:
Nippon Noson Igaku Kenkyusho Nenpo (Annu Rep Jpn Inst Rural Med ); 3: 216-250

Materials and methods

Principles of method if other than guideline:
see details in remarks on material and methods.
GLP compliance:
no

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): phthalide (4,5,6,7-tetrachlorophthalide)

Test animals

Species:
other: rats and mice
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
continuously in diet
Doses / concentrations
Remarks:
Doses / Concentrations:
5, 1, 0.2 and 0.04 %
Basis:

No. of animals per sex per dose:
no data
Control animals:
yes, plain diet

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: no data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood: no data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: no data
- Parameters checked in table [No.?] were examined: no data

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: no data
- Animals fasted: No data
- How many animals: no data
- Parameters checked in table [No.?] were examined: no data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
No change of the general situation was observed.

BODY WEIGHT AND WEIGHT GAIN
Inhibition of body weight increase was clearly recognized in the 5% group.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Intake of diet and water was greater only in the 5% group.

HAEMATOLOGY
No consistent trend of RBC, WBC, hemoglobin, hematocrit percentages or percentages of distribution of fractions of leucocytes was established.

CLINICAL CHEMISTRY
When total protein, albumin-globulin ratio, cholesterol content, urea nitrogen, blood sugar and SGPT were studied, only the last-mentioned value was reduced in the 5% group compared with all the groups.

HISTOPATHOLOGY: NON-NEOPLASTIC
According to pathohistological examination, fat degeneration and necrosis of the liver cells were recognized. Such as turbidity and swelling of renal tubular; epithelial cells, denaturation of fatty tissue and increase and regeneration of urinary cast were seen to a lesser degree. However, the dose-response relationship of these symptoms was not clear.

Effect levels

Dose descriptor:
NOAEL
Effect level:
0 other: none identified
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion