2-tert-butylphenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-02-1990 to 21-03-1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline 402 study followed to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-tert.-butylphenol

IUPAC Name:

2-tert.-butylphenol

Constituent 2

Reference substance name:

2-tert-butylphenol

EC Number:

201-807-2

EC Name:

2-tert-butylphenol

Cas Number:

88-18-6

Molecular formula:

C10H14O

IUPAC Name:

2-tert-butylphenol

Constituent 3

Reference substance name:

o.-tert.-butylphenol

IUPAC Name:

o.-tert.-butylphenol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2-tert.-butylphenol
- Physical state: liquid
- Analytical purity: 99.97%
- Purity test date: 2014-05-07
- Lot/batch No.: 1419
- Expiration date of the lot/batch: 05/2015
- Stability under test conditions: stable
- Storage condition of test material: under N2 in tightly closed container at a cool, well ventilated place
- Colour: clear

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River (U.K.) Ltd.
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 180-210 g (males); 120-140 (females).
- Fasted overnight
- Housing: In single sex groups of up to three rats in cages with stainless steel wire-mesh walls. floors and tops.
- Diet ad libitum: A pelleted diet (PRD. Special Diet Services Ltd - formerly Labsure Animal Foeds)
- Water ad libitum
- Acclimation period: 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19· to 23 degrees C
- Humidity (%): 30% to 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hour day and 12 hour night

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- Area of exposure: 6 x 8 cm
- Type of wrap if used: lint dressing (6 x 8cm) held with waterproof adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm dilute detergent solution and then dried.
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

A single dose of 1020, 1420 and 2000 mg/kg (males)
A single dose of 500, 729, 1020 and 2000 mg/kg (females)

No. of animals per sex per dose:

n= 5 males; n= 5 females.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made at least six times on Day 1 and twice daily thereafter for the remainder
of the 14 day observation period. The initial (Day 1), Day 8 and Day 15 bodyweight9 were recorded, and changes in bodyweight calculated.

- All animals were subject to necropsy.
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology.

Statistics:

No method specified

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 373 mg/kg bw

Based on:

test mat.

95% CL:

1 124

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

705 mg/kg bw

Based on:

test mat.

95% CL:

574

Mortality:

There were deaths on Days 2 to 5.

Clinical signs:

other: Haematuria was observed in all but 3 female rats dosed at 500 mg/kg. At doses above 700mg/kg bw - lethargy and, prior to death, lachrymation, pale eyes, hypothermia, prostration and coma. Isolated cases of skin pallor, periorbital encrustation, hunched

Gross pathology:

Darkened appearance and petechiation of thymus, soft brain, lung congestion, pallor and exaggerated lobular pettern of the liver.
Dark spleen, pallor of the renal cortex or darkening of the renal medulla, inflammation and abnormal content of the urinary bladder,
inflammation of the stomach and abnormal gastrointestinal contents. Four rats killed on Day 15 showed exaggerated hepatic lobular pattern.
No other internal macroscopic changes were found in rats surviving the effects of treatment. Findings of inflammation, dlscolouration,
scab formation and subcutaneous congestion or inflammation at the dermal test sites were consistent with in-life observations.

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Adverse clinical observations and adverse gross pathology was seen in animals at all doses tested.
The LD50 in males was 1373 mg/kg bw.
the LD50 in females was 705 mg/kg bw.

Executive summary:

In an OECD guideline 402 study, Fischer 344 rats (n=5 males; n-=5 females) were treated dermally with undiluted o-tert butyl phenol at a single dose of 1020, 1420 and 2000 mg/kg (males) and 500, 729, 1020 and 2000 mg/kg (females).

The LD50 in males was 1373 mg/kg bw.

the LD50 in females was 705 mg/kg bw.

There were a range of adverse clinical signs observed and adverse gross pathology abnormalities in liver, gut and kidney.