Dimethyl isophthalate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

Yasso.B, 01-09-2013

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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:

- Name of test material (as cited in study report): Dimethyl lsophthalate
- Substance type: solid
- Physical state: flakes
- Analytical purity: 99.85%
- Impurities (identity and concentrations): Meets acceptance criteria of <0.5% Dimethyl Terephthalate and 0 .05% ash
- Purity test date: Vendor certificate
- Lot/batch No.: 99275
- Expiration date of the lot/batch:April 2013
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature and humidity

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Raleigh NC
- Age at study initiation: ca 10 weeks
- Weight at study initiation: 268 - 328 g for males and 223 - 245 g for females.
- Housing: 1 per cage in suspended cages. The room was exclusively reserved for rats in acute tests.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) was provided daily
- Water (e.g. ad libitum): Water was available ad libitum
- Acclimation period: At least one week.

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hr light/ dark cycle

IN-LIFE DATES: From: To: Nov 19th 2012 to Dec 3rd 2012

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Test article was moistened with 0.50 ml of distilled water to form a pasty consistency

Details on dermal exposure:

TEST SITE
- Area of exposure: The area clipped began at the shoulders and extended to the hip bone and half way down the flank of each animal.
- % coverage: Approximately 10% of the body surface
- Type of wrap if used: A porous gauze dressing, then the torso was wrapped with a piece of porous dressing to retain the gauze dressing (semi-occlusive) and porous non-irritating tape encircled the entire trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed by gently washing with distilled water.
- Time after start of exposure: 24 Hours exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a dose level of 2000 mg/kg bw.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5% distilled water

Duration of exposure:

24 Hours

Doses:

a dose level of 2000 mg/kg bw

No. of animals per sex per dose:

five healthy male and five healthy, non-pregnant and nulliparous female

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: The animals were observed twice on Day 0 postdose and once daily for 14 days for mortality, toxicity and pharmacological effects Body weights were recorded pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed twice on Day 0 postdose and once daily for 14 days for mortality, toxicity and pharmacological effects.
Body weights were recorded pretest, weekly and at termination. Also at study termination all animals were examined for gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All ten animals survived the single 2000 mg/kg 24-hour dermal exposure without adverse effect.

Clinical signs:

other: Dermal Observations: At 24 hours and Day 14, erythema and edema were absent. Systemic Observations: There were no abnormal physical signs observed. Necropsy Findings: The gross necropsy revealed no observable abnormalities.

Gross pathology:

All animals were humanely sacrificed using CO2 following study termination and were examined for gross pathology. No abnormalities were observed.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LDso of Dimethyl Isophthalate is greater than 2000 mg/kg of bw in rats. The substance is not classified for acute dermal toxicity according to Regulation EC Nol. 1272/2008.