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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Only a very short summary of the test report is available in the 'Robust summary on Information on Reclaimed Substances: Naphthenic acids'. No detailed results are reported in this summary by which no interpretation of the reliability can be made based on the available information

Data source

Referenceopen allclose all

Reference Type:
other: robust study summary
Title:
Unnamed
Year:
2003
Report date:
2003
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthenic acids
EC Number:
215-662-8
EC Name:
Naphthenic acids
Cas Number:
1338-24-5
Molecular formula:
For the acidic (naphthenic) fraction: CnH2n+zO2, where n = carbon number and z = homologous group series number: z = 0 when no ring structures are present, z = -2 when 1 ring is present, z = -4 when 2 rings are present etc. For the non-acidic fraction: not applicable
IUPAC Name:
Naphthenic acids
Test material form:
liquid
Details on test material:
Physical state: Viscous liquid
Appearance: Pale yellow to dark amber

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
One time exposure
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 per sex
Details on study design:
0.1 ml naphthenic acid was placed into the conjunctival sac of eye of each of the six rabbits. The Iids were held together briefly to insure adequate distribution. The untreated eye served as a control.
The rabbits were observed at 1 and 4 hours and on days 1, 2, 3, 4 and day 7. If a positive score (any score for iritis or opacity, or a score of 2 or more for redness or chemosis) was noted on day 7, ocular reactions were scored on day 10. Likewise readings on day 14 were given if there was a positive reaction on day 10. Fluorescein was used in examining ocular reactions on day 3 and after. The Draize technique was used as the scoring system.

Results and discussion

In vivo

Results
Irritation parameter:
other: Draize scoring technique

Any other information on results incl. tables

The following is a summary of data taken from the report: One animal had a positive comeal score that was noted on days 1 and 2. One animal had a positive iris score which was noted during hours 1 and 4. All animals exhibited positive conjunctival scores at some point during the first three days of observation. By day 4 no animals showed positive scores.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is moderately irritating to eyes
Executive summary:

Rabbits were treated with 0.1 ml naphthenic acids into the conjunctival sac of one eye, and observed at 1 and 4 hours, and on days 1, 2, 3, 4, and day 7. Fluorescein was used in examining ocular reactions on day 3 and after. The Draize technique was used as the scoring system.

One animal had a positive corneal score that was noted on days 1 and 2. One animal had a positive iris score which was noted during hours 1 and 4. All animals exhibited positive conjunctival scores at some point during the first three days of observation, however by day 4, no animals showed positive scores. The material was judged to be an irritant.