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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous hydrocarbon liquid
Details on test material:
No. 6 Heavy Fuel Oil (API 78-6 with Specific Gravity 0.99/2.7%S),Fuel oil No. 6, CAS No. 68553-00-4.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9
Details on study design:
Comment: other: eyes not rinsed in 6 animals and rinsed with water in 3 animals after treatment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary irritation score
Basis:
mean
Time point:
other: 24 hrs
Score:
4
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Draize scores, unwashed
Irritation parameter:
other: primary irritation score
Basis:
mean
Time point:
other: 48 hr
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: draize score, unwashed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eye
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
8
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
12
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eye

Any other information on results incl. tables

Corneal opacities of grade 1 and area 1 were seen in three animals at the 24 and 48-hour reading.  No iridial inflammation was seen in any of the test animals. Conjunctival irritation was seen in all of the rabbits at 24 and 48 hours post dosing.  All rabbits were negative for irritation after 7 days. The test substance can be considered mildly irritating.  The maximum possible score at each time point is 110.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of the material into the conjunctival sac of the rabbit eye, caused only mild transient irritation. All effects had resolved 7 days post exposure
Executive summary:

Six New Zealand White rabbits were each treated with 0.1 mL of No 6 heavy fuel oil. An additional three animals were also treated with 0.1 ml of test substance, following which their eyes were rinsed with water. Effects on the eyes were monitored over 7 days with scoring according to the Draize scale.

Corneal opacities of grade 1 and area 1 were seen in some animals at the 24 and 48-hour reading. No iridial inflammation was seen in any of the test animals. Conjunctival irritation was seen in all of the rabbits at 24 and 48 hours post dosing. All rabbits were negative for irritation after 7 days. The test substance can be considered mildly irritating. The maximum possible score at each time point is 110.