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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:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, but sufficient details reported. Screening test with one rabbit only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Molecular formula: C3H6N6H3O4P
Molecular weight: 224
CAS number: 41583-09-9
Description: White solid
Batch: Not indicated
Purity: >98%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Not indicated
Specific Gravity: 1.74
Stability in vehicle: At least 96 h in 1% Aq. Carboxymethyl cellulose









Specific details on test material used for the study:
Identification Melapur MP
Description White solid
Batch Not indicated
Purity >98%
Test substance storage At room temperature in the dark
Stability under storage conditions Stable
Expiry date 01 January 1999

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no details reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml ( 42 mg)
Duration of treatment / exposure:
single exposure, no rinsing
Observation period (in vivo):
14 days; values are given for 1h, 24h, 48h, 72h and 7 days.
Number of animals or in vitro replicates:
one
Details on study design:
A sample of 41.8 mg (a volume of approx. 0.1 ml) was instilled in the conjunctival sac of one eye of an albino rabbit (New Zealand White, SPFquality) after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water was instilled into both eyes to determine corneal epithelial damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score 2 at 24h, score 1 at 48 and 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Other effects:
At the one hour reading, the scores were 1 for iris and redness of conjunctive and 2 for chemosis.

Any other information on results incl. tables

Instillation of approximately 42 mg (a volume of approx. 0.1 ml) into an eye of a rabbit resulted in effects on the iris and conjunctivae. The iridic irritation (grade 1) was noted on day 1 only. The irritation of the conjunctivae, which consisted of redness, chemosis and discharge, had completely resolved within 7 days in the animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU