Registration Dossier
Registration Dossier
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EC number: 941-650-3 | 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
- Study period:
- June 27, 1983 to July 1, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline claimed but test procedure is in accordance with guideline and described in sufficient details. Substance analytical certificate is not available.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
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:
- Paraffin (petroleum), normal, C5-C20
- IUPAC Name:
- Paraffin (petroleum), normal, C5-C20
- Reference substance name:
- MRD-83-207
- IUPAC Name:
- MRD-83-207
- Details on test material:
- - Name of test material (as cited in study report): MRD-83-207
- Substance type: Petroleum product, UVCB
- Physical state: clear liquid
- Analytical purity: considered to be 100% pure
- Composition of test material, percentage of components: C14-C17 normal paraffins
- Storage condition of test material: supplied at room temperature
- Reception date of the test article: January 19, 1983
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: 4 males, 2 females
- Source: Hazleton Dutchland, Inc., Denver, Pensylvania
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2.49 to 2.70 kg
- Housing: Individually, in suspended stainless steel
- Diet (e.g. ad libitum): Purine Rabbit Chow (pellets) ad libitum from Fisher and Son, Bound Brook, N.J. No analysis.
- Water (e.g. ad libitum): Automatic watering system, ad libitum from Elisabethtown Water Company, Elisabeth, N.J. Analysis provided by Elisabethtown Water Company.
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C (65-71 F)
- Humidity (%): 40-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): Approximately 12 hours light and 12 hours dark by automatic timer
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated contralateral eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.1 mL - Duration of treatment / exposure:
- The treated eyes of 6 animals remained unwashed.
- Observation period (in vivo):
- Observations at 1, 4, 24, 48 and 72 h post instillation and once per day on Days 4 and 7
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: 2% sodium fluorescein was used to confirm the presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no dye retention for 2 consecutive observations.
After the day 7 observations, all animals were euthanized with an I.V. injection of T-61 and discarded without futher examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.27
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1 for details
- Irritant / corrosive response data:
- Ocular exposure to MRD-83-207 resulted in redness in all animals at the 1 and 4 hour observations. The eyes of all animals were clear of irritation by 48 hours and the study was terminated after Day 7 observation.
- Other effects:
- Conjunctival discharge was noted in two animals at 1 hour (score 2 and 3) and was totally reversed at 4 hours in both rabbits.
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 |
0/0/0/0/0/0 |
1/ 1/0/1/1/1 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
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 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.0 |
0.0 |
0.27 |
0.0 |
Reversibility*) |
- |
- |
48 h |
- |
Average time (unit) for reversion |
- |
- |
c |
- |
*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- MRD-83-207 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 MRD-83-207 was investigated with a protocol in accordance with the OECD Guideline No. 405 (1981).
Six albino rabbits were exposed to 0.1 mL of the test article in the right eye. The eyes were examined and the changes were graded according to a numerical scale 1, 4, 24, 48 and 78 h after instillation and once per day on Day 4 and 7. The eyes were not rinsed after administration of the test substance.
No corneal and iridal lesion was observed throughout the observation period. Ocular exposure to MRD-83-207 only resulted in conjunctival redness (score 1 and 2 in all animals at 1 hour and 4 hours after instillation; then, slight redness was only observed in 5 animals at 24 hours). The eyes were clear of irritation by 48 hours in all animals: the mean score was 0.27 for conjunctival redness.
MRD-83-207 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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