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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chlorophthalic anhydride
EC Number:
204-179-8
EC Name:
3-chlorophthalic anhydride
Cas Number:
117-21-5
Molecular formula:
C8H3ClO3
IUPAC Name:
4-chloro-1,3-dihydro-2-benzofuran-1,3-dione

Test animals

Species:
rat
Strain:
other: Outbred albino (Rattus norvegicus)
Sex:
female
Details on test animals or test system and environmental conditions:
Five female outbred albino rats were received from Harlan, Inc. Indianapolis, IN. They weighed 202.7-214.8 g and were at least 49 days old. They were single housed upon arrival in polycarbonate cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Tap water was provided ad libitum throughout the study and feed was provided ad libitum, with the exception of overnight prior to dosing. The temperature and humidity were maintained at 68±5°F and 30-70%, respectively. Room lights were on a 12-hour light/dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
3-CLPA was a solid and was dosed as a suspension in cottonseed oil. The volume did not exceed 1 mL/100 g body weight.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
Food was withheld from the animals the night prior to dosing. Animals were administered a single dose of 3-CLPA by oral gavage. After dosing, the animals were returned to their cages and supplied with feed and water ad libitum.

The first animal was dosed at 2000 mg/kg. As the animal survived, the limit test was continued at the dose of 2000 mg/kg and the main test was not conducted. Four additional animals were dosed sequentially.

Careful clinical observations were made at least twice on the day of dosing. Special attention was given during the first four hours. Animals were observed daily for 14 days for clinical manifestations. Animals were weighed on Day 0, prior to dose administration, Day 7 and Day 14.

A gross necropsy was performed on all animals sacrificed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived to study termination.
Clinical signs:
other: No clinical manifestations of toxicity were observed over the course of the study.
Gross pathology:
No unusual findings were found during necropsy in all dosed animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 was determined to be > 2000 mg/kg body weight.
Executive summary:

Acute toxicity was determined in a study performed according to OECD 425 and in compliance with GLP criteria. In this study, 5 female Outbred albino (Rattus norvegicus) rats were exposed to a test concentration of 2000 mg/kg, which was administered orally gavage. Detailed clinical observations were made at least twice on the day of dosing with special attention in the first few hours, followed by daily observations for a period of 14 days. Observations included the incidence and severity of all abnormalities, including behavioral and clinical abnormalities, gross lesions, bodyweight changes, effects on mortality, and any other toxic effects. No effects were seen on survival and no clinical signs were observed. Furthermore, the animals gained weight during the study and no unusual findings were observed at necropsy. The LD50 was determined to be >2000 mg/kg body weight.