2-tert-butylphenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September and October 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to internationally accepted testing guideline, well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guideline, USA Interagency Regulatory Liaison Group (IRLG, January 1981)

GLP compliance:

no

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11-17 weeks
- Weight at study initiation: 2.52-2.87 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

Administration of the undiluted test substance as obtained, pH of test substance was determined as pH 5 (litmuspaper). During exposure the second animal showed severe pain, both eyes of the following 4 animals were therefore treated with a local anaesthetic ("Ophtaine", 0.5 % Proxymetacaine hydrochloride solution) several minutes before the application.

Observation period (in vivo):

2 hours, and 1, 2, 3, 4 and 7 days after application

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: modified Draize scoring system ("The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", 1959, The Association of Food and Drug Officials of the U.S.)

TOOL USED TO ASSESS SCORE: not mentioned

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

93

Max. score:

110

Reversibility:

not reversible

Remarks on result:

other: iris score of days 1 and 7 not accounted

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 3.00
- Iris: could not be evaluated on days 1 and 7 due to the severe chemosis
- Conjuntivae (Redness): 2.56
- Conjuntivae (Chemosis): 3.78

Other effects:

2 hours after treatment all animals showed redness of conjuctivae (1-3), evident chemosis (3-4) and excessive discharge. 4/6 animals showed opaque corneas. Due to the severe chemosis the cornea could not be evaluated at 2 animals and the iris could not be evaluated at all animals. Increased chemosis was seen at the following examinations, the conjuctivae were fleshy red. One animal had a conjunctival bleeding at day 3 and 4. After 7 days chemosis slighty decreased. At the beginning of the observation period the discharge was clear and liquid, later on it was more viscous and of a yellowish creamy consistence. The animals where the iris could be evaluated showed a sluggish reaction to light up to hemorrhage of the iris.
All animals showed cornea pannus after 7 days, additionally 2 animals showed damage of the corneal epithelium.

Any other information on results incl. tables

Table #: Mean irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Overall
	Max. score: 80 mean	Max. score: 10 mean	Max. score: 20 mean	Max. score: 110
2 h	40	0 *	16.33	56.33
1 d	60	0 *	13.66	73.66
2 d	60	9.16	17.33	86.50
3 d	60	5.83	18.33	84.16
4 d	60	7.50	18.66	86.16
7 d	76.60	0 *	16.33	93.00 **

 * = could not be evaluated; ** = iris score of days 1 and 7 not accounted

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Conclusions:

All animals showed cornea pannus after 7 days, additionally 2 animals showed damage of the corneal epithelium.

Executive summary:

In an acute eye irritation study according to USA Interagency Regulatory Liaison Group (IRLG, January 1981) Guideline, 0.1 ml of o-tert.-Butylphenol was instilled into the left eye of six male albino rabbits (New Zealand White strain). Eyes were not washed afterwards. Animals then were observed after 2 hours as well as after 1, 2, 3, 4, and 7 days. Irritation was scored by the method Draize (modified) and Kay & Calandra.

Under the experimental conditions employed, all animals showed cornea pannus after 7 days, additionally 2 animals showed damage of the corneal epithelium. Therefore, the test substance is considered to causes serious eye damage.