4-tert-butylphenol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

combined repeated dose and reproduction / developmental screening

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

other: unpublished

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

yes

Remarks:

no details provided on mating methods, or on housing or feeding of animals

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylphenol

EC Number:

202-679-0

EC Name:

4-tert-butylphenol

Cas Number:

98-54-4

Molecular formula:

C10H14O

IUPAC Name:

4-tert-butylphenol

Details on test material:

- Name of test material (as cited in study report): para-tertiary butylphenol, UCAR Butylphenol 4T-Flake (para tert-Butyl Phenol), PTBP.
- Physical state: White flakes.
- Analytical purity: Not reported.
- Lot/batch No.: Charge No. 496500; BRRC Sample No. 48-186.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous methyl cellulose

Details on oral exposure:

VEHICLE
- Justification for use and choice of vehicle (if other than water): None given
- Concentration in vehicle: 0.5%

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

Males - 6 weeks
Females - from 14 days prior to mating to day 4 of lactation

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
20, 60, 200 mg/kg body weight
Basis:
actual ingested

No. of animals per sex per dose:

13 animals/sex/dose

Control animals:

yes, concurrent vehicle

Details on study design:

- Dose selection rationale: None given

Positive control:

Not required

Examinations

Observations and examinations performed and frequency:

-General condition was observed (time schedule not reported)
-Food consumption (measured weekly)
- Body weights (measured weekly)
-Hematology (time schedule not reported). The following parameters were measured; red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, white blood cell count, band neutrophil, segmented neutrophil, eosinophil, basophil, monocyte, lymphocyte, and platelet count
-Serum biochemistry (time schedule not reported). The following parameters were measured: total protein, albumin A/G, BUN, creatinine, glucose, total cholesterol, total bilirubin, Na, K, Cl, Ca, inorg. phos., ALP, GPT, GOT, and gamma-GTP

Sacrifice and pathology:

SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals


GROSS NECROPSY
- Gross necropsy with recording of organ weights for the following organs; females - thymus, liver, and kidneys; males - thymus, liver, kidneys, testes, and epididymides


HISTOPATHOLOGY
Liver, kidney, thymus, spleen, lung, urinary bladder, stomach, testis, epididymis, and ovary tissues were prepared for microscopic examination

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

At 200 mg/kg body weight, some females showed stridor associated with dyspnea, likely caused by irritation of the respiratory tract. In males, decreased plasma albumin was reported in the 200 mg/kg body weight/day group. No compound specific morophological changes were observed following pathological examination of parental animals. Examination of body weights and gross morphology of the offspring revealed no effects of the compound administration. No adverse effects in pregnant and lactating females or their offspring were seen at any dose.

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

60 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: Abnormal respiratory sounds in a females in and decreased plasma albumin in males was reported in the 200 mg/kg body weight/day

Target system / organ toxicity

Key result

Critical effects observed:

not specified