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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:
8 April 1996 to 11 April 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Although conducted by a test method and following good laboratory procedures of the US FDA, there were several inconsistencies noted. The study protocol was not approved by the Sponsor prior to conduct of the study. The Study Director did not sign the study protocol. The study was not inspected by the Quality Assurance Unit during the progress of the study. The study was not conducted for sufficient time to determine reversibility of effects, although, after 72 hours effects observed were only minimal to mild. The dates of study conduct and final signed report dates differ by nearly 2 years.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Federal Hazardous Substance Act, 16 CFR 1500.42 (a)(b)(c)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
the study protocol was not approved by the Sponsor or signed by the Study Director; the study was not inspected by the Quality Assurance Unit during it progress.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
431-090-3
EC Name:
-
Cas Number:
190085-41-7
Molecular formula:
C19 H30 O3
IUPAC Name:
2-butyloctyl 2-hydroxybenzoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: A USDA licensed supplier
- Age at study initiation: not supplied
- Weight at study initiation: not supplied
- Housing: Animals were randomly assigned to cages on arrival and were housed individually in suspended stainless steel cages, six cages to a unit, in an environmentally controlled room.
- Diet (ad libitum): Agway Prolab High Fiber 5P25 Rabbit feed, alfalfa cubes
- Water (ad libitum): city tap water
- Acclimation period: at least 4 days prior to the start of testing

IN-LIFE DATES: From: 8 April 1996 To: 11 April 1996

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single application
Observation period (in vivo):
24, 48 and 72 hours post application
Number of animals or in vitro replicates:
6 animals, single exposure group
Details on study design:
The test substance was placed into the conjunctival sac of one eye of each treated rabbit. The lids were held together briefly to ensure adequate distribution of the test substance. The undosed (contrilateral) eye of each rabbit served as a control.

The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctivae at 24, 48 and 72 hours post application. After recording the 24-hour observation, the eyes were further examined with 1% Sodium Fluorescein solution to check for corneal opacity or injury. The eyes were then examined with Fluorescein at each observation point until no corneal staining was noted.

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:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks:
48h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The only irritant effects observed in the treated animals was minimal conjunctival redness in the eyes of 3 of 6 rabbits.

Redness
Rabbit #2: Day 1, Score 1; Day 2, Score 0; Day 3, Score 0
Rabbit #4: Day 1, Score 1; Day 2, Score 1; Day 3, Score 0
Rabbit #6: Day 1, Score 1; Day 2, Score 1; Day 3, Score 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material would not be considered a primary eye irritant as defined by the CLP criteria because no positive eye irritation occurred in any of the test animals during the study according to the definition of that .

The test material is not irritating to the eye according to the EU Directive 67/548/EEC as the individual animal scores ocular redness did not equal or exceed 2.5. No labeling is required.

The test material is not classified as an eye irritant under the GHS system based on mean overall scores for redness.
Executive summary:

The test article, C.P. Hall Company's sample of RX-13643, lot B.N. YZH012396, was dosed as supplied in accordance with the method described in the Federal Hazardous Substance Act (USA) 16 CFR 1500.42. It produced only minimal conjunctival redness in the eyes of 3 of 6 rabbits at either the 24 -hour and/or 48 -hour observation times. The overall irritation scores (mean) were 1.0 (24 hours), 0.7 (48 hours) and 0 (72 hours).