4-(1,1,3,3-tetramethylbutyl)phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November - December 19982

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Meets national standard methods with acceptable restrictions; test substance poorly described as "octylphenol"; no data on purity & impurities available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DOT regulation 173.1300 (46 FR 49889)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Octylphenol

EC Number:

266-717-8

EC Name:

Octylphenol

Cas Number:

67554-50-1

Molecular formula:

C14H22O

IUPAC Name:

2-octylphenol

Details on test material:

- Name of test material (as cited in study report): #748-120-2
- Purity: as received, no data on isomer composition
- Physical state: white powder
- Storage condition of test material: room temperature
- Other: Received from: Schenectady Chemicals, Inc.
- Date of receipt: November 10, 1982

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland, Inc. Denver, Pennsilvania
- Age at study initiation: young adults
- Weight at study initiation: no data
- Housing: individually in suspended stainless stell steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 36 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70°F
- Humidity (%): monitored daily
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

physiological saline

Remarks:

0.5 ml of 0.9%

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: 0.9% saline

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back from to the scapular to the lumbar region
- Type of wrap if used: 1"x1" surgical gauze square, eight layers thick

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with castile soap and warm water and rinsed immediately after the 4 hour dermal evaluation
- Time after start of exposure: immediately

SCORING SYSTEM: Draize Method, Primary irritation index (modified from method presented in Federal Hazardous Substances Yct Regulations, 16 CFR 1500)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: (superficial) necrosis

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 h

Score:

1.7

Max. score:

2

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Score:

4.5

Remarks on result:

other: calculated as "Total Sum/ 2"

Irritant / corrosive response data:

Raw data will be retained on file in the Bio/dynamics Archives.

Dermal Scores - 4 and 48 Hours:
Time Interval Observation Animal No. And Sex (M=male, F=female) N=Necrosis
391M 392F 395M 398F 403M 405M
4 hours Erythema 2 2 2 2 2 2
Edema 1 1 2 2 2 2
48 hours Erythema 2 4Nb 4N 2 4Nb 4Nb
Edema 2 2 2 2 2 2
Nb = Superficial necrosis

Any other information on results incl. tables

Special notations were made of necrosis, eschar or other evidence of irreversibel alteration of tissue structure.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Test material (referred to as octylphenol) is considered to be corrosive to the skin

Executive summary:

In a primary dermal irritation study young adult New Zealand White rabbits (4 males, 2 females) were dermal exposed to 0.5 g of Octylphenol in saline for 4 hours to the back from the scapular to the lumber region.  Animals then were observed for 2 days.  Irritation was scored by the method of Draize. The primary irritation index is 4.5. Four of six animals exhibited evidence of tissue destruction (necrosis) at 48 hours.

In this study, Octylphenol is corrosive to the skin. The study is not considered to be reliable due to the poor characterization of the test substance.