Registration Dossier
Registration Dossier
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EC number: 951-219-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable,well-documented study report similar or equivalent to OECD 405. GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Gasoline
- EC Number:
- 289-220-8
- EC Name:
- Gasoline
- Cas Number:
- 86290-81-5
- Reference substance name:
- unleaded gasoline
- IUPAC Name:
- unleaded gasoline
- Test material form:
- other: low viscosity liquid hydrocarbon
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- The eyes of 6 animals were left unrinsed after administration. The eye of the 3 animals was rinsed for one minute 20 to 30 seconds after test material instillation.
- Observation period (in vivo):
- Observations were made at 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- unrinsed: 6 animals
rinsed: 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed; max possible score of 110
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed; max possible score of 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed; max possible score of 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed; max possible score of 4
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed; max possible score of 2
- Other effects:
- Unleaded motor gasoline (API PS-6) was also instilled into the eyes of 3 rabbits, which were rinsed 20-30 seconds after dosing. This method is not in compliance with OECD TG 405 and is not appropriate for classification purposes. The overall irritation score was approximately 0.0 (max score out of 110 possible). The mean (24, 48, and 72 hr average) conjunctivae redness, chemosis, corneal opacity, and iris lesion scores were 0.0, 0.0, 0, and 0, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.0, and 0.0, respectively. These findings do not warrant classification of unleaded motor gasoline (API PS-6) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
Unleaded motor gasoline (API PS-6) was administered to one eye of six male New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours after treatment. Ocular damage was assessed and scored according to the Draize eye test.Ocular irritation was not observed after treatment and the overall irritation score was 0.0. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.0, and 0.0, respectively. These findings do not warrant classification of unleaded motor gasoline (API PS-6) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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