Registration Dossier

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:
end september - end october 2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
October 9th, 2017
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male albino New Zealand rabbits were supplied by Granja San Bernardo (Tulebras, Navarra –
Spain).
The animals were kept during a minimal 5-day acclimatisation period.
At the beginning of the test, the animals were 9 or 10 weeks old. They were identified prior to
inclusion in the test by means of a numbered ring on the edge of one ear.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0,1 g
Duration of treatment / exposure:
72 h
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.
Observation period (in vivo):
1 hour, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye after gently pulling
the lower lid away from the eyeball. The lids were then gently held together for about one second in
order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses in the first animal, two
additional animals were treated under the same experimental conditions.
Residual test item requiring a physiological saline rinse was noted in all animals at the reading time
1 hour. Pink coloration not preventing quotations was noted in all animals between Day 1 and the last
day of the test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritant / corrosive response data:
The ocular reactions observed during the study have been moderate to important and totally reversible:
-. at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation
in all animal and totally reversible between Days 2 and 7, a moderate to important chemosis noted 1
hour after the test item instillation in all animals and totally reversible between Days 1 and 3.
- at the corneal level: a moderate opacity, noted 24 hours after the test item instillation in one animal
and totally reversible on Day 7.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the
test item Red STR 172 does not have to be classified in accordance with the Regulation EC No.
1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.