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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:
2014-07-14 to 2014-08-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

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
Details on test material:
- Physical state: Light brown viscous liquid
- Analytical purity: 100%
- Expiration date of the lot/batch: 06 June 2016

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.48 and 2.68 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2014-07-14 to 2014-08-04

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of undiluted test item: 7.0
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Eyes were not rinsed throughout study
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 h following treatment.
An additional observation on Day 7 was made to assess reversibility of effects.
Number of animals or in vitro replicates:
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes 1 hour after treatment.
Moderate conjunctival irritation was noted in both treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation persisted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 48 hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 72 hour observation.
Both treated eyes appeared normal at the 7-day observation.
Other effects:
One animal showed a body weight loss and the other animal showed an expected gain in body weight during the study.

Any other information on results incl. tables

See attached document.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is irritating to the eye of rabbits. Classification as Eye Irrit. 2 in accordance with the CLP Regulation (EC) No. 1272/2008 is required.
Executive summary:

Test Guidance

OECD guideline 405 and EC Method B.5 (Acute Toxicity: Eye Irritation / Corrosion).

Method and materials

Two New Zealand White female rabbits were exposed to 0.1 mL of test item in the right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.

Results

No corneal effects were noted during the study. Iridial inflammation was noted in both treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in both treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation persisted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 48 hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 72 hour observation. Both treated eyes appeared normal at the 7-day observation.

One animal showed a body weight loss and the other animal showed an expected gain in body weight during the study.

Conclusion

The substance is irritating to the eye of rabbits. Under the test conditions, the substance is classified as irritating to eyes according to CLP Regulation (EC) No. 1272/2008.