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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:
Study carried out between the 29 February 2016 and 14 March 2016.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Ledum palustre, extract
EC Number:
289-997-3
Cas Number:
90063-39-1
Molecular formula:
UVCB substance, not relevant.
IUPAC Name:
Ledum palustre, extract
Test material form:
liquid
Details on test material:
UVCB substance : see composition at section 1

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 EUROLAP. The animals were kept during a minimal 5-day acclimatisation period.
At the beginning of the test, the animals were 10 or 11 weeks old.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of the test item was instilled
Duration of treatment / exposure:
Initially, a single animal was treated. After consideration of the responses in the first animal, two additional animals were treated in the same experimental conditions.
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: days 2 and 7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: days 2 and 7
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 24 hours after the test item instillation and totally reversible between days 3 and 7; associated with a slight chemosis noted 1 hour or 24 hours after the test item instillation and totally reversible between days 1 and 2.
- at the iris level: an injection noted 24 hours after the test item instillation and totally reversible between days 2 and 3.
- at the corneal level: a slight to moderate opacity, noted 24 hours after the test item instillation and totally reversible between days 2 and 7.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item Teinture mère de Ledum palustre – code L12C has to be classified in category 2 “Irritating to eyes” in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.