Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 observations were observed for the rest of the study.
Body weight:
All animals gained weight during the observation period.
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.