Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic information provided.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1999
Reference Type:
secondary source
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
Sodium erythorbate powder (100 mg) was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Reactions were compared between rinsed and unrinsed eyes and the following irritation parameters were noted: iris, conjunctival redness.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Erythorbate
- Physical state: Powder

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Rinsed eyes: 5 Seconds
Unrinsed eyes: Continuous
Observation period (in vivo):
1hr, 24hr, 48hr
Number of animals or in vitro replicates:
12 (10 male, 2 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean occular irritation score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 48 hrs
Score:
0.33
Irritation parameter:
other: Mean occular irritation score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 48 hrs
Score:
0.17
Irritant / corrosive response data:
Reactions were comparable in rinsed and unrinsed eyes, and were slight and transient in nature.

One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.

At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours.

The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes) (COLIPA 1982).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In a primary eye irritation study, 100 mg of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone powder was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Animals were then observed for 2 days. Irritation was scored by the method of Draize.

One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.

At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours. The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes).

In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye irritant.