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EC number: 208-878-9 | CAS number: 544-76-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 30 May to 6 June 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline N°405 but not in compliance with GLP. Substance analytical certificate provided by the manufacturer
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 30 May to 6 June 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline N°405 but not in compliance with GLP. Substance analytical certificate provided by the manufacturer
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- individual scores in all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- individual scores in all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3 mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritant / corrosive response data:
- No corneal damage or iridal inflammation was observed. A diffuse crimson-red coloration of the conjunctivae was only observed in two animals one hour after instillation. Temporary mild conjunctival irritation was noted in the third animal. The eyes were normal 48 hours after instillation in all rabbits.
- Other effects:
- No other lesions
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Petrepar-147 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C14-C17, n-alkanes, ≤2% aromatics based on analogue read across.
The eye irritant effect of Petrepar-147 was investigated according to the OECD Guideline No. 405 (1981).
Three albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 78 hrs and on day 4 and 7 after dosing. The eyes were not rinsed after administration of the test substance.
No corneal damage or iridal inflammation was observed. Redness and chemosis were observed in all animals, one hour after instillation. Slight redness was still observed in two animals at 24 hours while slight chemosis was only observed in one rabbit. The eyes of all rabbits were normal 48 hours after instillation. The mean individual scores were 0.33/0.33/0.0 for conjunctival redness and 0.33/0.0/0.0 for chemosis.
Petrepar-147 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
0/0/0 |
0/0/0 |
1/1/0 |
1/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0-0.0-0.0 |
0.0-0.0-0.0 |
0.33-0.33-0.0 |
0.33-0.0-0.0 |
Reversibility*) |
- |
- |
48 h |
48 h |
Average time (unit) for reversion |
- |
- |
c |
c |
*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
- EC Number:
- 917-828-1
- Molecular formula:
- none available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
- Reference substance name:
- Petrepar 147 (P-147)
- IUPAC Name:
- Petrepar 147 (P-147)
- Details on test material:
- - Name of test material (as cited in study report): Petrepar 147 (P-147)
- Substance type: petroleum product, UVCB
- Physical state: colourless liquid
- Analytical purity: 100 % commercial product
- Composition of test material, percentage of components: no data
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Pemberley Rabbits, Cottenham, Cambridgeshire
- Age at study initiation: approximately 9 to 11 weeks
- Weight at study initiation: 2.1 to 2.5
- Housing: individually in metal cages with perforated floors
- Diet : Free access to SDS Standard Rabbit Diet
- Water : Free access to tap water
- Acclimation period: yes but no data on period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained at approximately 19°C
- Humidity (%): maintained at approximately 30-70%
- Air changes: maintained at approximately 19 air changes per hours
- Photoperiod (hrs dark / hrs light): lighting was controlled to give 12 hours of artificial light (07.00-19.00) in each 24 hour period
Test system
- Vehicle:
- not specified
- Controls:
- other: the contralateral eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- Examinations at 1, 24, 48, 72 hours and on Day 4 and 7.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- SCORING SYSTEM: as prescribed by OECD No 405 guideline
TOOL USED TO ASSESS SCORE: handheld torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- individual scores in all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- individual scores in all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3 mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritant / corrosive response data:
- No corneal damage or iridal inflammation was observed. A diffuse crimson-red coloration of the conjunctivae was only observed in two animals one hour after instillation. Temporary mild conjunctival irritation was noted in the third animal. The eyes were normal 48 hours after instillation in all rabbits.
- Other effects:
- No other lesions
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
0/0/0 |
0/0/0 |
1/1/0 |
1/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0-0.0-0.0 |
0.0-0.0-0.0 |
0.33-0.33-0.0 |
0.33-0.0-0.0 |
Reversibility*) |
- |
- |
48 h |
48 h |
Average time (unit) for reversion |
- |
- |
c |
c |
*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Petrepar-147 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
The eye irritant effect of Petrepar-147 was investigated according to the OECD Guideline No. 405 (1981).
Three albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 78 hrs and on day 4 and 7 after dosing. The eyes were not rinsed after administration of the test substance.
No corneal damage or iridal inflammation was observed. Redness and chemosis were observed in all animals, one hour after instillation. Slight redness was still observed in two animals at 24 hours while slight chemosis was only observed in one rabbit. The eyes of all rabbits were normal 48 hours after instillation. The mean individual scores were 0.33/0.33/0.0 for conjunctival redness and 0.33/0.0/0.0 for chemosis.
Petrepar-147 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
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