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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from High Production Volume Information System (HPVIS)

Data source

Reference
Reference Type:
secondary source
Title:
Acute oral toxicity of Phenol, 2,4,6trimethyl- in rats
Author:
United States Environmental Protection Agency (EPA)
Year:
2017
Bibliographic source:
High Production Volume Information System (HPVIS)| OPPT | US EPA

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Acute oral toxicity study of Phenol, 2,4,6trimethyl-) in rats
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

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
IUPAC Name:
2,4,6-trimethylphenol
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): 2,4,6-trimethylphenol
- Molecular formula (if other than submission substance): C9H12O
- Molecular weight (if other than submission substance): 136.21 g/mol
- Substance type: Organic
- Physical state: solid
- Impurities (identity and concentrations): NA
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenol, 2,4,6-trimethyl- (2,4,6-trimethylphenol )
- Molecular formula (if other than submission substance): C9H12O
- Molecular weight (if other than submission substance): 136.1928 g/mole
- Substance type: Organic
- Physical state: No data available
Purity 87.72%
- Impurities (identity and concentrations):O-Cresol = 0.11%;2,6 Xylenol = 0.81%; 2,4/2,5 Xylenol = 5.61%; 2,3,6-Trimethylphenol = 1.58%; 2,6 EMP = 4.03%; Unknowns = 4.17%) Measured

Test animals

Species:
rat
Strain:
other: rattus norvegicus
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Age at study initiation: 8 weeks old
- Weight at study initiation: 201 to 221 g
- Fasting period before study: All animals were fasted the night prior to dosing.
- Diet (e.g. ad libitum): Following dosage, the rats were provided feed, ad libitum
- Water (e.g. ad libitum): Following dosage, the rats were provided water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg TMP/kg body weight
- Amount of vehicle (if gavage): 1 mL/100 gm body weight
- Justification for choice of vehicle: Cottonseed oil

DOSAGE PREPARATION (if unusual): The test substance was a solid and was suspended in cottonseed oil. The dose was calculated using a concentration of 1 gm/mL.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 male/ 3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs, body weight and gross pathology.
Statistics:
No data availableNo data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated male and female rat at 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, which was resolved by Day 4 of the study. No unusual clinical observations were observed for
Gross pathology:
No unusual lesions were observed in treated male and female rat.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was estimated to > 2000 mg/kg bw when rattus norvegicus male and female rats were treated with Phenol, 2,4,6-trimethyl-orally by gavage.
Executive summary:

In a acute oral toxicity study,rattus norvegicus male and femalerats were treated withPhenol, 2,4,6-trimethyl- in the concentration of 2000 mg/kg bw orally by gavage and observed for 14 days. No mortality was observed in treated male and female rat. 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, which was resolved by Day 4 of the study. No unusual clinical observations were observed for the rest of the study. All animals gained weight during the 14-day post-dose observation period. No unusual lesions were observed in treated male and female rat. Therefore,LD50 was estimated to > 2000 mg/kg bw whenrattus norvegicus male and femalerats were treated withPhenol, 2,4,6-trimethyl-orally by gavage.