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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:
1986-10-06 to 1987-01-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, is well documented and acceptable for assessment. Combined study and thus reporting lacking in some details, hence restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [CAS Number 171171-80-5]
- Physical state: Dark brown viscous liquid
- Lot/batch No.: XSA 053J
- Storage condition of test material: In the dark at ambient temperature
- Stability under test conditions: Infra-red spectra taken on 14 August 1986 and 18 December 1986 showed no differences and the substance was judged to have been stable for the duration of the study

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding Unit
- Age at study initiation: 3-6 months
- Weight at study initiation: 3664-3860 g (males) and 2952-3460 g (females)
- Housing: Singly in hanging, stainless steel cages with all-mesh floors and tops and half-mesh fronts; each cage measuring 67 cm x 43 cm x 45 cm. The cages were mounted in three rows of two on a single-sided rack (a total of six cages).
- Diet: Standard Rabbit Diet, SQC, Special Diet Services Ltd, Essex) ad libitum by means of a top loading food hopper
- Water: Filtered but untreated water from the public supply ad libitum by means of an automatic valve-regulated drinking line
- Acclimation period: = 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 degrees Centigrade
- Photoperiod: Automatically controlled cycle of light (06:00 to 18:00) and dark (18:00 to 06:00)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Three males and three females
Details on study design:
Each rabbit was identified by means of a anumbered 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. 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 the animals were observed immediately after instillation and the initial pain response graded as shown in the scoring criteria (attached).

A visual assessment of eye irritancy was made at 1 h, 4-7 h, 24 h, 48 h, 72 h, and 7 d after instillation. Irritancy was scored for the cornea, iris and conjunctivae using the standard scores attached. At 24 h, and in the event of any corneal damage, visualisation was aided by the instillation of one drop of 2 % flurescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
redness
Time point:
other: 1 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
redness
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
redness
Time point:
other: 7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
discharge
Time point:
other: 1 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
discharge
Time point:
other: 4 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
discharge
Time point:
other: 7 d
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
opacity
Time point:
other: 1 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
opacity
Time point:
other: 24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
opacity
Time point:
other: 48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
opacity
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
area
Time point:
other: 1 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
area
Time point:
other: 24 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
area
Time point:
other: 48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
area
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
2
Irritant / corrosive response data:
Instillation of the undiluted test substance into the conjunctival sac of one eye did not cause a pain response in any of the six rabbits. One rabbit (870 M) had opacity in a small area of the cornea within 1 h of dosing at which time all rabbits had minimal to moderate conjunctival redness, which persisted (or had increased) at 24 h post dosing. At this time, two rabbits (872 M and 885 M) had developed opacity of the cornea but this and all other ocular effects had cleared by 7 d post dosing.

Any other information on results incl. tables

The effect of the test material on rabbit eyes is summarised in Table 4 (attached).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: experimental observation
Conclusions:
On administration of the test material there was no initial pain response. The test material caused moderate conjunctival redness initially in all six rabbits and minimal corneal opacity in three rabbits. All effects had cleared by 7 days and the test material was therefore considered only a very mild irritant to rabbit eyes.