Registration Dossier

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
NA
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Purity batch
> 99.0 % 7.32% active oxygenBatch 247408973
99.27 % 9407226339; 247408999
99.6 % 0410105225413
> 97 % 4289070300; 0419101226056
99.1 % 11600 0010-108
99.3 % 247413988
99.4 % 7.35 % active oxygen Batch 247409800
98.9 % 0707518256
> 99.1 % 247412384
98.5 % 0707603153
99.0 % 1703465433
99.5 % 150726; 247413309
99.3 % 000055055

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
Housing: rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters
Conditioning period: 21 days prior to study initiation
Diet: ad libitum
Water: ad libitum
Body weights prior to administration: 2257 to 2817 g

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as the untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
one application
Observation period (in vivo):
24, 48, 72 hrs, 7 days
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
None of the rabbits received a washout


TOOL USED TO ASSESS SCORE: After grading the eye reaction, one drop of sodium fluorescein (at 72 hrs, 7 days) was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
32829/M
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
32841/M
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
32843/M
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #4
Remarks:
32732/F
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #5
Remarks:
32834/F
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #6
Remarks:
32840/F
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
animal #1
Remarks:
32829/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
32841/M
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
32843/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
32732/F
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
32834/F
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
32840/F
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Other effects:
NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the data obtained and in accordance with OECD GHS (1272/2008) the test material is evaluated as not irritating to eyes.
Executive summary:

Tert.-Butylperoxy- 2-ethylhexanoat was tested in three male and 3 female New Zealand White rabbits similar to OECD guideline 405. Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2 % sodium solution. Rabbits exhibiting corneal lesions were discarded. The rabbits received 0.1 mL of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. The treated eyes were examined in accordance with the following schedule: 24 hrs following instillation, 48 hrs, 72 hrs and 7 days. After grading the eye reaction, one drop of sodium fluorescein (at 72 hrs, 7 days) was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light. Based on the data obtained and in accordance with OECD GHS (1272/2008) the test material would not be considered a primary eye irritant.