2,4,6-trimethylphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trimethylphenol

EC Number:

208-419-2

EC Name:

2,4,6-trimethylphenol

Cas Number:

527-60-6

Molecular formula:

C9H12O

IUPAC Name:

2,4,6-trimethylphenol

Test material form:

other: powder or cake

Details on test material:

- Name of test material (as cited in study report): 2,4,6-Trimethyl phenol (TMP, Mesitol)
- Batch #: (Grade 8093)
- Description: White crystalline powder or cake
- Physical state: Solid
- Stability: Stability under normal storage and use conditions
- Storage: Room temperature (in hood preferably)
- Color: White

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Indianapolis, IN
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 200.9 - 220.7 g
- Fasting period before study: the night before dosing
- Housing: Group housing: maximum of 3 per cage of the same sex; Polycarbonate cages; Bedding: Hardwood chips, (contact), Prochip, Harlan Teklad, Madison, WI.
- Diet: TEK 7012 Rodent Diet, Harlan Teklad, Madison, WI, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: minimum of 5 days, under the same conditions as for the actual test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12-Hour light/dark cycle, full spectrum fluorescent lights

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1 g/mL
- The administered volume did not exceed 1 mL/100 g bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Careful clinical observations were made at least twice on the day of dosing. Animals were observed daily for clinical manifestations. Animals were weighed at Day 0 prior to dose administration, Day 7, and Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died exposed to 2000 mg/kg bw.

Clinical signs:

other: Piloerection was observed in all test animals for the first day of the study. All signs of piloerection were resolved by Day 3 of the study in all but one animal. Piloerection in this animal was resolved by Day 4 of the study. No unusual clinical observat

Gross pathology:

No unusual lesions were noted in any of the animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under conditions of this test the LD50 was determined to be above 2000 mg/kg bw.

Executive summary:

In a GLP compliant OECD 423 guideline study, three Sprague-Dawley rats per sex were exposed to 2000 mg/kg bw 2,4,6-Trimethyl Phenol (TMP, Mesitol) dissolved in cottonseed oil via oral gavage. After an observation period of 14 days animals were necropsied. Piloerection was observed in all test animals for the first day of the study, which was resolved in all animals by Day 4. No mortality was observed and no unusual lesions were noted upon necropsy. The LD50 was determined to be above 2000 mg/kg bw.