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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In accordance with internationally valid GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
EPIKOTE 862

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
ANIMALS
Source: Sittingbourne Research Centre Breeding Unit
Age: 3-6 months
Acclimatization: 2 weeks
Housing: singly in stainless steel cages
Food: ad libitum, Standard Rabbit Diet, S.Q.C. and water
Temperature: 16-22 degrees C
Lighting: 12 hour light dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The eyes were not washed after treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male, 3 female
Details on study design:
The eye irritancy was assessed using a method based on that described in the OECD Guidelines. 6 rabbits, between 4.2 and 5.1 kg were used. 0.1 mL of undilute test substance was placed into the lower conjunctival sac of one eye on each rabbit and the lids held together for a few seconds to prevent lose of material. The eyes were not washed. An initial pain assessment was made and graded on scale from 1 to 6. The eye irritancy was scored at 1, 4, 24, 48, 72 hours and 7 days after exposure for cornea, iris and conjunctivae using the standard scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
No initial pain response

Any other information on results incl. tables

Animal No. and sex

Initial effect

 

Time after instillation

1 h

4 h

24 h

48 h

72 h

7 d

921 M

 

 

 

 

923 M

 

 

 

 

924 M

 

 

 

 

879 F

 

 

 

 

878 F

 

 

 

 

906 F

 

 

 

 

None

 

 

 

 

None

 

 

 

 

None

 

 

 

 

None

 

 

 

 

None

 

 

 

 

None

 

 

 

 

Redness

Chemosis

Opacity

Iris

 

Redness

Chemosis

Opacity

Iris

 

Redness

Chemosis

Opacity

Iris

 

Redness

Chemosis

Opacity

Iris

 

Redness

Chemosis

Opacity

Iris

 

Redness

Chemosis

Opacity

Iris

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

0

0

0

0

 

0

0

0

+0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

Mean Score

 

Grade

 

 

 

1

Redness

Chemosis

Opacity

Iris

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
In the rabbit eye irritancy test, 0.1 mL of the test material caused no irritation. On administration of the test material there was no initial pain response.
Executive summary:

Six adult albino rabbits were used to evaluate eye irritating properties of BPFDGE when instilled in eye. The test substance (0.1 ml undiluted) was instilled in the conjunctiva sac of one eye. Irritation and injury to the cornea, iris, and conjunctiva were scored at 1, 24, 48, 72 hr and 7 days after the initial exposure. Based on the findings from this study, BPFDGE is not an eye irritant.