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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-07-22 to 1985-08-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The method of Draize, as described in the Federal Register (1963) was used
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
Molecular formula:
Na(C21-25H33-41O3)
IUPAC Name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
Details on test material:
- Physical state: Dark brown liquid
- Stability under test conditions: Stable for the duration of the study
- Expiry date: Assigned as one calendar month from the date of issue (18 July 1985)
- Storage conditions of test material: In the dark at ambient temperature
- Date received: 08 July 1985
- Density/Specific gravity: 0.985 kg/L at 20 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age on receipt from supplier: 3-6 months
- Age at study initiation: 4-9 months
- Weight at study initiation: 4312-4682 g (female); 4220-4360 g (male)
- Housing: Singly housed in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cage measured 67 x 43 x 45 cm. The cages were mounted in three rows of two on a single-sided rack (a total of six cages).
- Diet: ad libitum by means of a top-loading food hopper
- Water: Filtered but untreated from water from the public supply by means of an automatic valve-regulated drinking line
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 °C
- Humidity: Monitored but values not stated
- Air changes: No data
- Photoperiod: Light 06:00 to 18:00 GMT; Dark 18:00 to 06:00 GMT via fluorescent tubes

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
7 days (all animals); 14 days (5 out of 6 animals)
Number of animals or in vitro replicates:
Three males and three females
Details on study design:
Each rabbit was identified by means of a numbered metal ear tag and/or a number written on the pinna.

The day before testing, the eyes of the rabbits were carefully examined for any damage, and any animals showing damage were replaced. A dose of 0.1 mL of the undiluted test material was placed into the lower conjunctival sac of one eye of each rabbit and the lids held together for a few seconds to prevent loss of material. The eyes were not washed.

The reactions of each animal were observed immediately after instillation and the initial pain response graded (see table, attached). A visual assessment of eye irritancy was then made at 1 hour, 24 hours, 48 hours, 72 hours and 7 days after instillation. Five of the six rabbits were retained and observed at 14 days post-dosing. Irritancy was scored for the cornea, iris and conjunctivae using standard scores detailed in the attached listings. In the event of any corneal damage visualisation was aided by the instillation of one drop of 2 % fluorescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
other: 1h
Score:
0
Max. score:
2.5
Remarks on result:
other:
Remarks:
additional timepoints used in study (1h-14d)
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
48 h
Score:
0.5
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
7 d
Score:
2.5
Remarks on result:
other:
Remarks:
additional timepoints in older study
Irritation parameter:
cornea opacity score
Basis:
animal: 838M
Time point:
14 d
Score:
2.5
Remarks on result:
other:
Remarks:
additional timepoints in older study
Irritation parameter:
iris score
Basis:
animal: 838M
Time point:
24/48/72 h
Score:
0
Max. score:
0.5
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
24 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
48 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
72 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
7 d
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 838M
Time point:
14 d
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
other: 1h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
24 h
Score:
1.5
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 838M
Time point:
14 d
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
24 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
48 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
72 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
7 d
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 839M
Time point:
14 d
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
other: 1h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
7 d
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 839M
Time point:
14 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
other: 1h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
7 d
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 839M
Time point:
14 d
Score:
3
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
other: 1h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
24 h
Score:
0.5
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
48 h
Score:
0.5
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
72 h
Score:
0.5
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
7 d
Score:
1
Irritation parameter:
iris score
Basis:
animal: 839M
Time point:
14 d
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
24 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
48 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
72 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
7 d
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 840M
Time point:
14 d
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
other: 1h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
24 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
7 d
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 840M
Time point:
14 d
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
other: 1h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
48 h
Score:
0.5
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
7 d
Score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: 840M
Time point:
14 d
Score:
3
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
other: 1h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
72 h
Score:
0.5
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
7 d
Score:
0.5
Irritation parameter:
iris score
Basis:
animal: 840M
Time point:
14 d
Score:
0.5
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
24 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
48 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
72 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
7 d
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 843F
Time point:
14 d
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
other: 1h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
24 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
7 d
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 843F
Time point:
14 d
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
other: 1h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
24 h
Score:
0.5
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
7 d
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 843F
Time point:
14 d
Score:
1.5
Irritation parameter:
iris score
Basis:
animal: 843F
Time point:
24/48/72 h
Score:
0
Max. score:
0.5
Irritation parameter:
conjunctivae score
Basis:
animal: 844F
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 844F
Time point:
24/48/72 h
Score:
2.5
Max. score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 844F
Time point:
7 d
Score:
2.5
Irritation parameter:
chemosis score
Basis:
animal: 844F
Time point:
other: 1h
Score:
1.5
Irritation parameter:
chemosis score
Basis:
animal: 844F
Time point:
24 h
Score:
1.5
Irritation parameter:
chemosis score
Basis:
animal: 844F
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 844F
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 844F
Time point:
7 d
Score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: 844F
Time point:
other: 1h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 844F
Time point:
24 h
Score:
0.5
Irritation parameter:
cornea opacity score
Basis:
animal: 844F
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 844F
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 844F
Time point:
7 d
Score:
2.5
Remarks on result:
other: vascularisation
Remarks:
vascularisation considered permanent and test terminated at 7d
Irritation parameter:
iris score
Basis:
animal: 844F
Time point:
24/48/72 h
Score:
0
Max. score:
0.5
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
other: 1h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
48 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
72 h
Score:
2.5
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
7 d
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 845F
Time point:
14 d
Score:
0.5
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
other: 1h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
24 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
48 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
7 d
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 845F
Time point:
14 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
other: 1h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
48 h
Score:
0.5
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
7 d
Score:
1.5
Irritation parameter:
cornea opacity score
Basis:
animal: 845F
Time point:
14 d
Score:
2
Irritation parameter:
iris score
Basis:
animal: 845F
Time point:
other: 1h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 845F
Time point:
24/48/72 h
Score:
0
Max. score:
0.5
Irritant / corrosive response data:
The instillation of the undiluted test material into the conjunctival sac of one eye of each of six rabbits resulted in severe initial pain. The conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed, and the mean total scores calculated. The results are shown in Table 3 (attached).

All rabbits had moderate inflammation of the conjunctivae within one hour of dosing, which persisted up to 7 days. During this period all animals developed corneal opacity and had transient iritis. At 7 days 844 F had extensive vascularisation of the cornea, which is considered a permanent effect; this animal was therefore killed. Of the remaining five rabbits, four also developed extensive corneal vascularisation by day 14 so the test was terminated.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the modified Kay and Callandra rating system, the test material can be classified as severely irritating to rabbit eyes; on the basis of the permanent effects seen (extensive vascularisation of the cornea) the test material would be classified as Category 1 (1272/2008).
Executive summary:

The potential of the test material to cause eye irritation was assessed in a study conducted using methodology equivalent to that outlined in the standardised guideline OECD 405 under GLP conditions.

0.1 mL of the test material was instilled into the eye of three male and three female New Zealand White rabbits. The dose of the undiluted test material was placed into the lower conjunctival sac of one eye of each rabbit and the lids held together for a few seconds to prevent loss of material. The eyes were not washed.

The reactions of each animal were observed immediately after instillation and the initial pain response graded (see table, attached). A visual assessment of eye irritancy was then made at 1 hour, 24 hours, 48 hours, 72 hours and 7 days after instillation. Five of the six rabbits were retained and observed at 14 days post-dosing. Irritancy was scored for the cornea, iris and conjunctivae using standard scores detailed in the attached listings. In the event of any corneal damage visualisation was aided by the instillation of one drop of 2 % fluorescein solution.

The instillation of the undiluted test material into the conjunctival sac of one eye of each of six rabbits resulted in severe initial pain. The conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed, and the mean total scores calculated.

All rabbits had moderate inflammation of the conjunctivae within one hour of dosing, which persisted up to 7 days. During this period all animals developed corneal opacity and had transient iritis. At 7 days 844 F had extensive vascularisation of the cornea, which is considered a permanent effect; this animal was therefore killed. Of the remaining five rabbits, four also developed extensive corneal vascularisation by day 14 so the test was terminated.

On the basis of the modified Kay and Callandra rating system, the test material can be classified as severely irritating to rabbit eyes; on the basis of the permanent effects seen (extensive vascularisation of the cornea) the test material would be classified as Category 1 (1272/2008).