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Toxicological information

Eye irritation

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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

Constituent 1
Reference substance name:
2-tert.-butylphenol
IUPAC Name:
2-tert.-butylphenol
Constituent 2
Chemical structure
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.