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:
Not provided
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FDA standards
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Bourgeonal
- Substance type: clear colourless liquid
- Physical state: Liquid
- Lot/batch No.: 148983

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.

- Age at study initiation:
Adult

- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.5 - 3.0 kg

- Housing:
Not specified in the report

- Diet (e.g. ad libitum):
Not specified in the report

- Water (e.g. ad libitum):
Not specified in the report

- Acclimation period:
Not specified in the report

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not specified in the report

- Humidity (%):
Not specified in the report

- Air changes (per hr):
Not specified in the report

- Photoperiod (hrs dark / hrs light):
Not specified in the report

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: EXAMPLE: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit):
A volume of 0.2 ml .

- Concentration (if solution):
Undiluted and used as supplied

VEHICLE

- Amount(s) applied (volume or weight with unit):
Not applicable

- Concentration (if solution):
Not applicable

- Lot/batch no. (if required):
Not applicable

- Purity:
Not reported
Duration of treatment / exposure:

72 hours
Observation period (in vivo):

Approximately 24, 48 and 72 hours and 7 days following treatment
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done):
Not applicable

- Time after start of exposure:
Not applicable


SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 2
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks:
No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 3
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 4
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 5
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 6
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effect observed
Irritation parameter:
iris score
Basis:
animal: 1
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 2
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 3
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 4
Time point:
other: Mean 24, 48 and 72
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 5
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
other: Redness
Basis:
animal #1
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #2
Time point:
other: Mean 24, 48 and 72 hors
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #3
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #4
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #5
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #6
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
The ocular effects of bourgeonal generally consisted of slight redness and swelling of the conjunctivae.

After seven days these lesions had cleared up only partially.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Pure and undiluted bourgeonal caused slight eye irritation and according to the FDA-standards it is not considered to be an eye irritant.
Executive summary:

Pure and undiluted Bourgeonal caused slight eye irritation and according to the FDA-standards it is not considered to be an eye irritant.