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Diss Factsheets

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:
December 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: CFR 1500.42 - Test for eye irritants.
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
Observation period lasted 72 hours.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-sec-butyl-2,6-di-tert-butylphenol
EC Number:
241-533-0
EC Name:
4-sec-butyl-2,6-di-tert-butylphenol
Cas Number:
17540-75-9
Molecular formula:
C18H30O
IUPAC Name:
4-(butan-2-yl)-2,6-di-tert-butylphenol
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
According to DHEW standards in a USDA registered, AAALAC accredited facility
- Source: Isaacs Lab Stock
- Age at study initiation: Not specified
- Weight at study initiation: at least 1.5 kg.
- Housing: In cages
- Diet: Not specified
- Water: Not specified
- Acclimation period: A minimum of 7 days




Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single instillation on day 1.
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6
Details on study design:
Healthy appearing animals were examined with sodium fluorescein 24 hours prior to administration of the test substance in the right eye, no abnormalities were found.
The test substance was placed in the conjunctival sac of the eye. Lids were held closed for ca 1 second after instillation of the test article.

The cornea, iris and conjunctivae where examined for 3 consequetive days and scored for irritation.

Scoring:

Cornea (a)
Opacity: degree of density (readings should be taken from most dense area)
No opacity .............................................................................................................. 0
Scattered or diffuse areas details
of iris clearly visible ................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ........................................... 2
Opalescent area; no details of iris visible; size of pupil barely discernible ..................................... 3
Opaque, iris invisible ............................................................. 4

Area of Cornea involved (b)
one quarter(or less) but not zero......................................................1
Greater than on quarter, but less than half.........................................2
Greater than half but less than three quarters......................................3
Greater than three quarters, up to whole area.....................................4
Score equals a x b x 5, Total maximum = 80

Iris
values (a)
Normal......................................................................................................................................... 0
Folds above normal, congestion, swelling, circumcorneal
injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive).................... 1
No reaction to light, hemorrhage, gross destruction, (any or all of these) ............................................................... 2
Score equals a x 5 total maximum = 10

Conjunctivae
a)Redness (refers to palpebral conjunctivae only)
Vessels normal......................................................................................................................................... 0
Vessels definitely injected above normal ................................................................................. 1
More diffuse,deeper crimson red; individual vessels not easily discernible............................................... 2
Diffuse beefy red ......................................................................................................................... 3

Chemosis (b)

No swelling......................................................................................................................................... 0
Any swelling above normal (includes nictitating membrane)....................................................................................................... 1
Obvious swelling, with partial eversion of lids........................................................................... 2
Swelling with lids about half closed........................................................................................... 3
Swelling with lids about half closed ro completely closed.................................................................................... 4

Discharge (c)
No discharge.......................................................................0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)...........................1
Discharge with moistening ofthe lids and hairs just adjacent to lids ...........................................................2
Dischrage with moistening of the lids and haris and considerable area around the eye..........................................................3
Score equals (a+b+c) x 2 Total maximum = 20

The total score for the eye is the sum of all scores obtained for the cornea, iris and conjunctivae.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: incl. Chemosis score
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: incl. Chemosis score
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: incl. Chemosis score
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: incl. Chemosis score
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: incl. Chemosis score
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: incl. Chemosis score
Irritant / corrosive response data:
Slight redness to the conjunctivae was observed in all animals 24 hours after application. Effects were in 3/6 rabbits reversible within the observation period of 72 hours. Although not all results were reversible the effects were very slight, and therefore considered to be reversible within 14 days.

Any other information on results incl. tables

See illustration, Overall remarks.

Sodium fluorescein did not show any additional irritation effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The potential of test article XC-132 to cause irritation to the eye was evaluated using the rabbit according to FHSA procedures (16 CFR 1500.42) similar to OECD 405. Only slight redness of the conjunctivae was observed. Effects show to be reversible in some but not all rabbits after 72 hours, however the effects were very slight, and therefore considered to be reversible within 14 days. Therefore no classification for eye irritation according to GHS and CLP criteria is required.
Executive summary:

The potential of compound XC-132 to cause irritation to the eye was examined according to FHSA procedure (CFR 1500.42) similar to OECD 405. 0.1 mL of the test substance was applied in the eye of the test animal. Observation occured on 1st, 2nd and 3rd day after application. Slight redness of the conjunctivae was observed. These effects were reversible in 3/6 rabbits within 72 hours, the sustained effects were very slight, and therefore considered to be reversible within 14 days.

Based on the results XC-132 , XC-132 does not have to be classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments) as no full reversibily has been proven.