4-tert-butylphenol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

ACUTE TOXICITY AND PRIMARY IRRITATION OF PARA-TERTIARY BUTYLPHENOL

Author:

Klonne DR, Myers RC, Nachreiner DJ & Homan ER

Year:

1988

Bibliographic source:

DRUG AND CHEMICAL TOXICOLOGY, 11(1), 43-54 (1988)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

- reliability scoring based on 1981 guideline

Deviations:

yes

Remarks:

- test concentration was 5.6 mg/L for 4-h exposure test; chamber volume > 20 L for 6-h exposure test; see Additional Information on Material and Methods

GLP compliance:

no

Test type:

standard acute method

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: Zivic-Miller Laboratories, Inc., Zelienople, PA; Harlan Sprague Dawley, Inc., Indianapolis, IN.
- Age at study initiation: Not reported.
- Weight at study initiation: Between 200 and 300 g.
- Fasting period before study: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Animals were maintained on appropriate commercial diet, ad libitum.
- Water (e.g. ad libitum): Animals were maintained on municipal water, ad libitum.
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

other: Test 1: Vapour (6-hour exposure study); Test 2: dust aerosol (4-hour exposure study)

Type of inhalation exposure:

whole body

Vehicle:

other: no data

Details on inhalation exposure:

Groups of 5 male and five female rats were exposed for 6 hour to a substantially saturated vapor of PTBP under static conditions (Test 1) or for 4 hour to a dynamically generated dust aerosol (Test 2).

Test 1: For the static vapor exposure, 100 g of PTBP was placed in a 120 L Plexiglas® (Rohm & Hass Co.) and stainless steel chamber for approximately 18 hour at ambient temperature prior to introduction of the male or female rats. Oxygen content was maintained at greater than 19% during the exposure.

Test 2: A respirable dust aerosol was produced to simulate industrial preparation of PTBP by melting the flakes in a flask maintained at 110°C. Filtered compressed air then carried the vapors to a 120 L Plexiglas® chamber where the PTBP condensed in air to a fine powder. The dust concentration was determined by standard gravimetric techniques using 47 mm glass fiber filters. The particle size distribution was determined with a TSI Model APS 3300 Aerodynamic Particle Sizer (St. Paul, MN) fitted with an In-Tox Products dilutor (Albuquerque, NM). The mass median aerodynamic diameter (MMAD) and geometric standard deviation were calculated by probit analysis. To assess the vapor concentration of PTBP in the chamber, air samples were pulled through 2 midget impingers containing acetone, after first filtering out all solid particulate material with glass fiber filters. Liquid samples were then analyzed with a gas chromatograph fitted with a flame ionization detector.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Test 2: average aerosol concentration was gravimetrically determined; Test 1: concentration of test substance in air not reported.

Duration of exposure:

6 h

Remarks on duration:

For Test 1; 4 h exposure for Test 2

Concentrations:

Test 1: 100 g of test substance was placed in 120 L chamber.
Test 2: 5.6 mg/L.

No. of animals per sex per dose:

5/sex/group.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days for Tests 1 and 2.
- Frequency of observations and weighing: For Tests 1 and 2, clinical signs of toxicity were observed once daily during post-exposure period. Body weights were measured on Days 0, 7 and 14 for both Tests 1 and 2.
- Necropsy of survivors performed: Yes (for Tests 1 and 2).

Statistics:

Statistical analysis is not required (Acute toxicity test).

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

other: No LD50 value determined

Effect level:

100 other: g in 120 L chamber

Exp. duration:

6 h

Remarks on result:

other: Test 1: 6 hour exposure killed 0 of 10 animals.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

other: No LD50 value determined

Effect level:

5.6 mg/L air (nominal)

Exp. duration:

4 h

Remarks on result:

other: Test 2: 20% mortality was observed

Mortality:

Test 1: None of the 10 animals died during the 6 hour exposure.
Test 2: Within 1 to 2 days following exposure, 1 of 5 male rats and 1 of 5 female rats died.

Clinical signs:

other: Test 1: There were no effects in rats from exposure to a statically generated substantially saturated vapor for 6 hours on clinical signs. Test 2: Clinical signs observed on the day of exposure and up to 7 days post-exposure included signs of mucosal ir

Body weight:

Test 1: There were no effects in rats from exposure to a statically generated substantially saturated vapor for 6 hours on body weight.
Test 2: A loss of mean body weight was observed for both sexes on post-exposure Day 7, but body weight gains were exhibited on Day 14.

Gross pathology:

Test 1: There were no effects in rats from exposure to a statically generated substantially saturated vapor for 6 hours on necropsy observations.
Test 2: Dark red or purple discoloration of the lungs and/or kidneys were observed in the two rats that died but no macroscopic lesions were observed in survivors.

Other findings:

Test 2: The 4 hour dynamic exposure was conducted at a mean ± standard deviation concentration of 5.6 ± 0.8 mg/L of PTBP dust aerosol, with an additional vapor component of 0.03 mg/L. The MMAD for the dust was 3.6 microns with an geometric standard deviation of 2.0.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)