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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
other: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information taken from a Company report from 1971, updated by original study author in 2010. Report contains some gaps in experimental conditions, but results are sufficient in detail for evaluation.

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1971
Report Date:
1971
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The Federal Hazardous Substances Act regulation 191.12 as amended September 17, 1964
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Furan, tetrahydro-- Lot/batch No.: Haskell No. 7170

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No information on environmental conditions provided.Animals used on this study were free of pre-existing corneal or conjunctivalinjury or irritation.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application, eyes unwashed
Observation period (in vivo):
Up to 14 days
Number of animals or in vitro replicates:
6
Details on study design:
An aliquot of 0.1 mL of H-7170 was introduced into the lower conjunctival sac of the right eye of each rabbit. The left eye of each rabbit was not treated with the test substance and served as a control. The treated and control eyes of all rabbits remained unwashed. Approximately 24, 48, and 72 hours, and 14 days after H-7170 was administered, the rabbits were examined for evidence of eye irritation. At each of these observation periods, eyes were examined using illumination and a hand-slit lamp and scored for ocular reactions according to the Draize Scale (Table 1). Control eyes were not scored. These untreated eyes were used for comparison and were considered "normal" relative to the treated eye. A biomicroscope was used to check for any positive iritic reactions and corneal effects at 14 days. The rabbits were weighed on the day of treatment, at 24 hours after instillation, and at the last ocular evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Positive as defined under Section 191.12 of the Federal Hazardous Substances Act
Basis:
other:
Remarks on result:
other: 6/6 positive
Irritation parameter:
other: Cornea
Basis:
other:
Reversibility:
not reversible
Remarks on result:
other: 6/6 animals, opacity
Irritation parameter:
other: iris
Basis:
other:
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 6/6 animals, iritis
Irritation parameter:
other: conjunctiva
Basis:
other:
Reversibility:
not specified
Remarks on result:
other: redness, 6/6 diffuse crimson redness; 2/6 swelling with lids about half closed; 3/6 swelling with partial eversion of lids
Irritation parameter:
other: cornea
Basis:
other: irreversible corneal damage
Time point:
other: 14 days
Reversibility:
not reversible
Remarks on result:
other: 2/6 animals; readings of eyes made at 14 days with the use of a biomicroscope.
Irritant / corrosive response data:
Two of the six rabbit eyes exposed to tetrahydrofuran had severe, irreversible corneal damage.

Any other information on results incl. tables

Table 1. Individual animal scores for eye irritation.

Animal No.

Corneal opacity

Iritis

Conjunctival Redness

Conjunctival Chemosis

Biomicroscope

24 hour

8222

8223

8224

8225

8226

8218

1

1

>1

2

1

1

1

1

1

1

1

1

2

2

2

2

2

2

2

1

2

3

3

2

-

-

-

-

-

-

48 hour

8222

8223

8224

8225

8226

8218

1

1

2

>2

1

1

0

1

1

1

1

1

2

2

2

2

2

2

1

1

1

1

1

1

-

-

-

-

-

-

72 hour

8222

8223

8224

8225

8226

8218

>1

2

2

>2

1

1

0

1

0

1

1

0

2

2

2

2

2

2

1

1

1

1

1

1

-

-

-

-

-

-

14 days

8222

8223

8224

8225

8226

8218

3

1

2

1

1

3

0

0

0

0

0

0

1

0

1

0

0

1

0

0

0

0

0

0

Severe

Mild

Moderate

Mild

Mild

Severe

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the definition of the eye test in the regulations of the Federal Hazardous Substances Act, tetrahydrofuran is classified as an eye irritant. Two of six rabbit eyes exposed to tetrahydrofuran had severe, irreversible corneal injury.
Executive summary:

Tetrahydrofuran caused moderate to severe eye irritation in rabbits, which were not reversible by 14 days. This is consistent with the CPT (1978) study, which only followed animals for 7 days, but found comparable lesions. It is proposed that THF be considered as a severe (Category 1) eye irritant under GHS.