Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990/05/02-1990/05/15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 405. GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Sex: female (6)
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.48-2.75 kg
- Housing: Individually
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted with new food each day
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-70
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat

Duration of treatment / exposure:
Test material was introduced into the lower conjunctival sac of the right eye of each animal, the upper and lower lids were gently held together for one second prior to releasing to prevent loss of material.
Observation period (in vivo):
1, 4, 24, 48, and 72 hrs post instillation and once per day on days 4 and 7.
Number of animals or in vitro replicates:
Female (6)
Details on study design:
SCORING SYSTEM: Draize scale for ocular irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 1 hr
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24 hrs
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 48 hrs
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
1.33
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hrs
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hrs
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-72 hrs
Score:
0
Irritant / corrosive response data:
Redness was noted for all animals at the 1 hr observation point, for 3 animals at the 24 hr observation point, and for two animals at the 48 hr observation point. Chemosis was noted for all animals at the 1 hr observation and for 1 animal at the 24 hr observation point. Only one animal was noted in having discharge at the 1 hr time point. All animals were free of any occular irritation after the 48 hr observation. The maximum Draize score was 8 at the 1 hr time point.

Any other information on results incl. tables

Summary of other eye irritation studies:

Chemical Name: Hydrocarbons, C9, aromatics  
Reference Substance:          
CAS Number: 64742-95-6        
EC Number: 265-199-0        
SMILES:          
End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.2 Eye Irritation 7.3.2 Draize Eye Irritation Studies - Rabbits  Rabbit Experimental result Equivalent or similar to  OECD guideline 405 Eyes of some animals were irrigated 2 Acceptable, well-documented study report in general agreement with OECD guideline 405. Not performed according to GLP. No     MRD-61-14 not irritating Study report ANON 1961 Draize Eye Irritation Studies - Rabbits HSPA0147 Hazleton Laboratories ExxonMobil Petroleum & Chemical BVBA 61MRL7 yes
8.2 Eye Irritation 7.3.2 Ocular Irritation Study in the Rabbit Rabbit Experimental result Equivalent or similar to  OECD guideline 405 Failed to continue study to 21 days when symptoms were still present at 72 hrs.  2 Similar to OECD guideline 405. yes MRD-90-720 not classifiable Study report ANON 1990 Ocular Irritation Study in the Rabbit HSPA0150 Exxon Biomedical Sciences, Inc.  172013 ExxonMobil Petroleum & Chemical BVBA 90MRL166 12/06/1990 yes
8.2 Eye Irritation 7.3.2 Eye Irritation Study in Rabbits Rabbit Experimental result Equivalent or similar to  OECD guideline 405 No 2 Similar to OECD guideline 405. No data MRD-ECH-80-14 not irritating Study report ANON 1980 Eye Irritation Study in Rabbits HSPA0148 Bio/dynamics Inc. 29641 ExxonMobil Petroleum & Chemical BVBA 80MRL16 11/07/1980 yes
8.2 Eye Irritation 7.3.2 Eye Irritation  Rabbit Experimental result According to Federal Register, 28, (110), 6.6.1963. para 191.12. Test for eye irritation. No 2 Summary only of study. No data Shellsol A not irritating Study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0686 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the individual and mean scores of ocular irritations, test substance would not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

This study was conducted to determine the potential of the substance to cause irritation to the eye in a rabbit model system. Six rabbits were instilled with 0.1 ml of MRD-89 -522, neat. Ocular examinations occurred at 1, 4, 24, 48, and 72 hrs, and days 4 and 7 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Maximum observed Draize score was 8. Irritation subsided as the study progressed and all animals were clear of ocular irritation after the 48 hr observation. Based on the individual and mean scores, test substance should not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.