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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
11/13/2012 to 02/28/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl isophthalate
EC Number:
215-951-9
EC Name:
Dimethyl isophthalate
Cas Number:
1459-93-4
Molecular formula:
C10H10O4
IUPAC Name:
1,3-dimethyl benzene-1,3-dicarboxylate
Test material form:
solid: flakes
Details on test material:
Opaque white solid
- Name of test material (as cited in study report): Dimethyl Isophthalate, CAS# 1459-93-4,
- Physical state: Solid
- Analytical purity: 99.85%
- Impurities (identity and concentrations): Dimethyl Terephthalate, <0.5% (Maximum) (accepted level)
- Purity test date: 10-23-2012
- Lot/batch No.: Batch# 99275
- Expiration date of the lot/batch: 04/2014
- Storage condition of test material: Room Temperature and humidity
- Other: Melting point 67-68 degC

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Raleigh NC and SAGE Labs, Boyertown, PA,
- Age at study initiation: 3 weeks
- Weight at study initiation: 182 - 223 grams
- Housing: The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing
- Diet (e.g. ad libitum): Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing
- Water (e.g. ad libitum): Ad libidum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled but not reported the actual temperature
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): a 12-hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% in methyl cellulose
- Lot/batch no. (if required): Methyl Cellulose, Lot# AD-11326-58 and Tween 80®, Lot# A0313394

DOSAGE PREPARATION (if unusual):
Test article was ground with mortar and pestle and electronic grinder. The test material was mixed with 2% Methylcellulose to make a 20% white slurry mixture.
Vehicle preperation:
2.0 g Methylcellulose powder was added to 100 ml of warm distilled water
while on stir plate; two drops of Tween® 80 were added to the mixture; the mixture remained on a stir plate until solution began to gel and was then placed in the refrigerator overnight. The vehicle was prepared for each dose. (2% Methylcellulose solution) (Clear colorless liquid)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: comply with the standards set forth in OECD Guidelines for the Testing of Chemicals
Doses:
2000 mg/kg of BW
The test article was mixed with 2% methylcellulose to make dosing by gavage possible. The dose was based on the dry weight of the test article. Initially, a single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to three female rats. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg.
No. of animals per sex per dose:
Initially three healthy female Sprague Dawley rats were dosed orally with Dimethyl Isophthalate, at 2000 mg/kg. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days.
Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, toxicity and pharmacological effects, and twice daily for mortality. All animals were examined for gross pathology.

Results and discussion

Preliminary study:
Initially, a single dose was administered orally by gavage at a dose level of 2000 mg/kg to three female rats
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0 of 6 female rats. All six females survived the single 2000 mg/kg oral dose
Clinical signs:
other: There were no abnormal physical signs observed.
Gross pathology:
The gross necropsy of all animals revealed no observable abnormalities in five out of six animals; hematomas were observed on the ovaries of one animal.
Other findings:
The gross necropsy of all animals revealed no observable abnormalities in five out of six animals; hematomas were observed on the ovaries of one animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dimethyl Isophthalate was tested in an OECD 423 guideline study of acute oral toxicity by gavage. The oral LD50 is greater than 2000 mg/kg body weight in female rats. The conclusion is that the substance is not classified for acute oral toxicity according to Regulation EC No. 1272/2008.