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:
October 8 - 30, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrofurfuryl alcohol
EC Number:
202-625-6
EC Name:
Tetrahydrofurfuryl alcohol
Cas Number:
97-99-4
Molecular formula:
C5H10O2
IUPAC Name:
(oxolan-2-yl)methanol
Details on test material:
- Name of test material (as cited in study report): Cryoban A

- Physical state: Clear liquid

- Storage condition of test material: Sealed container at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products Inc., Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2549-3004 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 42-74
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4 males
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV-light / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0.5
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
not reversible
Remarks:
minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 2
Max. score:
4
Reversibility:
not reversible
Remarks:
minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
individual animal data are missing - Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual animal data are missing
Remarks:
Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
Irritant / corrosive response data:
Conjunctival irritation was observed in the treated eye of all animals, including positive reactions for four animals. Iridial and corneal irritation were present in the treated eye of five animals, respectively. All iridial and corneal irritation completely subsided by day 7 and day 21, respectively, or earlier. Conjunctival irritation completely subsided by day 7 or earlier for five rabbits. Minor conjunctival irritation persisted through study termination for one animal.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was found irritating to the eyes of rabbit, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjuntival chemosis of ≥2 in 3 animals.