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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 10, 1981 - August 24, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study meets the criteria laid out in OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Procedure used was that described in the Proposed Guideline of the United States Environmental Protection Agency (EPA) S 163.81 - 4 "Primary eye irritation study", Federal Register Vol. 43, No. 163, August 2, 1978 that were in draft at time of study conduct and subsequently adopted.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
ESBO
IUPAC Name:
ESBO
Constituent 2
Reference substance name:
Epoxidised Soybean Oil
IUPAC Name:
Epoxidised Soybean Oil
Constituent 3
Reference substance name:
Soybean oil, epoxidized
EC Number:
232-391-0
EC Name:
Soybean oil, epoxidized
IUPAC Name:
232-391-0
Constituent 4
Reference substance name:
8013-07-8
Cas Number:
8013-07-8
IUPAC Name:
8013-07-8
Constituent 5
Reference substance name:
Soybean Oil, epoxidised
IUPAC Name:
Soybean Oil, epoxidised
Details on test material:
- Name of test material (as cited in study report): TK 11'278
- Physical state: Liquid
- Lot/batch No.: prod. Oct. 80

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at constant room temperature of 22 ± 2°C, at a relative humidity of 55 ± 10% and on a 12 hour light cycle day. The animals had ad libitum access to standard rabbit food and water.

Prior to treatment they were adapted to the laboratory for a minimum of 4 days. Only rabbits with normal opthalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each rabbit served as the inherent control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
9 - three rinsed and six not rinsed after installation
Details on study design:
0.1 mL of undiluted test material was instilled into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14 and was scored for each individual rabbit.

As the test compound is not soluble in water, an assessment of pH was not performed prior to dosing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: PII
Remarks:
Primary Irritation Index
Basis:
mean
Remarks:
Kay and Callendra system
Time point:
other: 24 hours
Score:
4.7
Max. score:
20
Reversibility:
fully reversible within: 10 days
Irritation parameter:
other: PII
Remarks:
Primary Irritation Index
Basis:
mean
Remarks:
Kay and Callendra system
Time point:
other: 24 hours
Score:
3.3
Max. score:
20
Reversibility:
other: after 7 days only one of the three animals had slight conjunctival redness
Irritant / corrosive response data:
The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours.
On this basis the mean results for the rinsed eyes (scores for six rabbits) were -
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 1.06
Conjunctival swelling/chemosis = 0.61
and for the rinsed eyes the mean values for 24-72 hours were:
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 0.89
Conjunctival swelling/chemosis = 0.56.
No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7.


Other effects:
No symptoms of systemic intoxication were observed throughout the whole test period.

Any other information on results incl. tables

Calculation of the primary eye irritation index

Time after exposure days

Mean reaction score

Unrinsed eyes (A)

Rinsed eyes (B)

Cornea

iris

conjunctiva

cornea

iris

conjunctiva

1

0

0

4.7

0

0

3.3

2

0

0

3.3

0

0

2.7

3

0

0

2

0

0

2.7

4

0

0

1.3

0

0

1.3

7

0

0

1

0

0

0.7

10

0

0

0

0

0

0.7

14

0

0

0

0

0

0.7

The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours. On this basis the mean results for the rinsed eyes (scores for six rabbits) were - corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 1.06 Conjunctival swelling/chemosis = 0.61 and for the rinsed eyes the mean values for 24-72 hours were: corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 0.89 Conjunctival swelling/chemosis = 0.56. No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The read-across substance ESBO was found to be a mild eye irritant under the conditions of this study.
Executive summary:

The eye irritation potential of the read-across substance ESBO was investigated in a test performed on three male and six female New Zealand White rabbits. In the unrinsed eyes no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean acore of 4.7 after 24 hours. After 10 days all irritation had disappeared. In the rinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. No symptoms of systemic intoxication were observed throughout the whole test period. Reactions reassessed using EU classification criteria confirm that values do not exceed the EU thresholds for triggering classification.

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