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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (405): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
EC Number:
701-314-7
Molecular formula:
CnH2n+2O2. n=24-33
IUPAC Name:
Alkenes, C6-11 (branched), hydroformylation products, distn. residues, heavy cracked fraction
Details on test material:
- Name of test material (as cited in study report): MRD-85-608
- Physical state: liquid
- Analytical purity: assumed 100 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat (assumed 100%)
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Observations at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Driaze

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks:
Effect seen at 48 hours and fully reversible at 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Remarks:
male
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Remarks:
male
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #2
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #3
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #4
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #5
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #2
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #3
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #4
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #5
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #2
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #3
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #4
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #5
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Iritis
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #6
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #6
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
male
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Effects were fully reversible within 72 hours in all but one animal; no indication of irritation in animal #6

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registered substance was found to be slightly irritating to the eyes. Effects were reversible within 4 days.
Executive summary:

The ocular irritation potential of the registered substance was evaluated following a single 0.1 ml instillation to the right eye of 6 rabbits. The treated eyes of all animals remained unwashed. Observations for signs of ocular irritation and toxicity were made at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7. Ocular reactions were graded according to the Draize scale for scoring ocular lesions. Minimal irritation was observed in the animals; responses were limited to the conjunctiva and included redness, chemosis and discharge. All effects were fully reversible within 7 days post-instillation. In all but one animal, all effects were fully reversed within 4 days post-instillation.