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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: glittery semi-liquid
Details on test material:
Colour: orange

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
During the test, the animals (females) weighed between 1.93 kg and 2.56 kg. At the beginning of the test, the animals were 10-12 weeks old.

Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23 °C and 30 to 70 %, respectively.
The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water and foodstuff were supplied freely.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated serving as control.
Amount / concentration applied:
0.1 mL of the test item was instilled as supplied.
Duration of treatment / exposure:
24 hours of exposure.
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed.

Number of animals or in vitro replicates:
Three female albino New Zealand rabbits were treated sequentially.
After consideration of the responses produced on day 3 in the first animal, two additional animals were treated, in the same experimental conditions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.7
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.7
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.7
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.7
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;
- at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.
- at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3.
Other effects:
None.

Any other information on results incl. tables

 Animal No.     Time after treatment        CONJUNCTIVAE  IRIS  CORNEA
 Chemosis (A)  Redness (C)  Lesion (D)  Opacity (E)
1           24 hours  0  2  0  0
 48 hours  0  1  0  0
 72 hours  0  0  0  0
 Mean  0.0  1.0  0.0  0.0
2  24 hours  1  2  1  2
48 hours   1  2  0  2
72 hours   1  1  0  0
Mean   1.0  1.7  0.3  1.3
3 24 hours   2  2  0  2
48 hours   1  2  0  0
72 hours   1  1  0  0
 Mean  1.3  1.7  0.0  0.7

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item C.A.E. Code: 8500010 was instilled as supplied into the eye of three New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established according to the OECD guideline No.405 dated April 24th, 2002 and the test method B.5 ohe council regulation No.440/2008.

 

The ocular reactions observed during the study have been slight to important and totally reversible:

-  at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;

-  at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.

-  at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3.

 

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

 

In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified.No signal word or hazard statement is required.