reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

between 2005-06-15 to 2005- 08-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study; study report is documented with minor deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OPPTS 870.1 000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): OS1 621 70K
- Molecular formula (if other than submission substance): C21H34O3
- Molecular weight (if other than submission substance): 334.491
- Smiles notation (if other than submission substance): Oc1c(C(C)(C)C)cc(cc1C(C)(C)C)CCC(=O)OCCCC
- InChl (if other than submission substance): 1S/C21H34O3/c1-8-9-12-24-18(22)11-10-15-13-16(20(2,3)4)19(23)17(14-15)21(5,6)7/h13-14,23H,8-12H2,1-7H3
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: alkylated phenol
- Physical state: brown liquid
- Analytical purity: 100% (provided by the Sponsor)

- Stability under test conditions: the material is normally stable at moderately elevated temperatures and pressures
- Storage condition of test material: room temperature and humidity
- Other: specific gravity: 0.97

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: The animals were born the weeks of 2005- 04-05 & 2005-05-03 and received at the test facility on 2005-05-31 & 2005-06-21.
- Weight at study initiation: 05. The pretest body weight range was 205 - 214 grams for males and 210 - 220 grams for females.
- Fasting period before study:
- Housing: in suspended wire mesh cages 5/sex/cage prior to dosing and 3/sex/cage following dosing. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): ad libitum at all times
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not applicable

MAXIMUM DOSE VOLUME APPLIED: 0.45 mL, or 2000 mg/kg based on specific gravity of the test material

DOSAGE PREPARATION (if unusual): 0.42-0.45 mL

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3/per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1,2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology

Statistics:

Mean and SD were calculated for body weights

Results and discussion

Preliminary study:

Not performed

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no deaths

Mortality:

No deaths

Clinical signs:

other: No sings of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

No further findings were noted

Applicant's summary and conclusion

Interpretation of results:

other: Category 5

Remarks:

Criteria used for interpretation of results: other: according to the grading system presented in the study report

Conclusions:

The test material is considered to be in Acute Toxic Category 5. The LD50 is greater than 2000 mg/kg.

Executive summary:

The objective of the study was determination of the potential for oral toxicity using the Acute Toxic Class Determination. This study is designed to comply with the standards set forth in OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in OPPTS 870.1 000 (December 2002) as an acceptable method to assess lethality within a dose range. Three healthy male and three healthy female Wistar albino rats were dosed orally with the test material at 2000 mg/kg bw. The rats were observed 0.5,1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. The test article was assigned to a toxic category based on the mortality response noted. Summary: All animals survived the 2000 mg/kg oral dose in good health. There were no abnormal physical signs noted during the observation period. Body weight changes were normal in 5/6 animals. One female lost weight during the second week of the observation period. Necropsy results were normal. The test material is considered to be in Acute Toxic Category 5. The LD50 is greater than 2000 mg/kg bw.