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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:
4 October 2000 to 13 October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: Grey powder
- Storage conditions: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet: standard laboratory rabbit diet ad libitum (Special Diet Services STANRAB (P) SQC pellet)
- Water: ad libitum (potable water for human consumption)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (0600 - 1800)

IN-LIFE DATES: From 4 October 2000 to 13 October 2000


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

TREATMENT PROCEDURE
- The weight of the test material which when gently compacted occupied a volume of 0.1 mL exceeded 100 mg on all occasions. However, 100 mg only was placed in the lower everted lid of one eye of each animal. The eyelids were gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Duration of treatment / exposure:
The treated eyes were not washed following test material installation.
Observation period (in vivo):
All animals were observed daily for signs of ill health or toxicity. Examinations of the eyes were made 1, 24, 48 and 72 hours after installation.
Number of animals or in vitro replicates:
3
One animal was treated in advance of the other two, to ensure that if a severe response was produced, no further animals would be exposed.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation was not performed.

SCORING SYSTEM: The reactions were scored in accordance with the numerical system outline in field "Any other information on materials and methods incl. tables".

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
score of three animals
Time point:
other: mean scores at 24, 48 and 72 hours
Score:
0
Remarks on result:
other: No corneal damage was observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
score of three animals
Time point:
other: mean scores at 24, 48 and 72 hours
Score:
0
Remarks on result:
other: No iridial inflammation was observed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
score of three animals
Time point:
other: mean scores at 24, 48 and 72 hours
Score:
0.1
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Redness was seen in the eye of one male rabbit after 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
score of three animals
Time point:
other: mean scores at 24, 48 and 72 hours
Score:
0
Remarks on result:
other: No chemosis was observed
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Transient, hyperaemia of the blood vessels of the conjunctivae was seen in all animals, resolving completely by either one or two days after instillation.

Any other information on results incl. tables

Table 1: Ocular Reactions

Means of scores at approx. 24, 48 and 72 hours after administration
Animal No. Corneal opacity Iridial lesions Conjunctival
Redness Chemosis
1389 0 0 0 0
1456 0 0 0.3 0
1457 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test according to OECD 405, the test material elicited only transient, very slight conjunctival irritation in any of the animals during the course of the study, meaning that the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The eye irritation potential of the test material was determined in accordance with the standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400. Approximately 0.1 mL of test material was applied into one eye each of three rabbits and the animals assessed for 3 days to determine the grade of ocular reaction.

No corneal damage or any iridial effects were seen. Conjunctival effects consisted of transient, very slight irritation in one animal approximately 24 hours after installation. All signs of irritation had completely resolved 1 to 2 days following test material installation.

Under the conditions of the study, the test material is considered to be practically non-irritating to the eyes based on an internal system for description of irritation responses. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.