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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
431-540-9
EC Name:
-
Cas Number:
170573-32-7
Molecular formula:
C21H43NO2
IUPAC Name:
N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: "l'elevage Cunicole de Val de Seile, 80160 Prouzel, France"
Acclimation: at least 5 days
Weight: 2.6 +/- 0.2 kg
Temperature: 20 +/- 3°C
Relative humidity: 50 +/- 20%
Light period: 12h light / 12h dark
Feed: "Lapins entretien reference 112 C" (U.A.R., 91360 Villemoisson-Sur-Orge, France), ad libitum
Water: filtered tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL in the conjunctival sac of the left eye
Duration of treatment / exposure:
One application
Observation period (in vivo):
1, 24, 48 and 72h
Number of animals or in vitro replicates:
3
Details on study design:
Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: after 1 h
Score:
>= 0 - <= 2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: chemosis, enanthema and redness
Irritation parameter:
other: eye watering
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
not determinable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Some slight conjunctival reactions (chemosis with a score < or = to 1, enanthema with a score of 1 to 2, and redness with a score of < or = to 1.3) were observed in the 3 rabbits after 1h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72h.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was not considered to be irritating to rabbit eye.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.5, in compliance with GLP. Three male rabbits (New-Zealand White) received 0.1 mL of the undiluted test substance in the conjunctival sac of the left eye. The right eye remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h. Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris). Some slight conjunctival reactions (chemosis with a score of ≤ 1 and enanthema with a score of 1 to 2) were observed in the 3 rabbits after 1 h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Clouzeau, 1992).