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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:
16 Nov 2015 - 01 Dec 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,6-Hexanediol
- Test-item No.: 13/0044-1
- Physical state: solid/colorless
- Analytical purity: 95.9 corr. area %
- Lot/batch No.: 000STD77L0
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Expiration date of the lot/batch: August 13, 2016
- Homogeneity: The test item was homogeneous by visual inspection
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.23 kg – 2.59 kg
- Housing: Single housing
- Diet: STANRAB (P) SQC; SDS special Diets Services, ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- For better handling the test item was heated at 45°C. The test item was heated for each test animal shortly before administration in addition to
stirring with a spatula and a magnetic stirrer. The homogeneity of the test item during administration was ensured by stirring with a magnetic stirrer The test item was administrated lukewarm.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: after 24 hours of exposure

SCORING SYSTEM: according to the quoted guidelines

TOOL USED TO ASSESS SCORE: hand-slit lamp ans otoscope lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Reversibility:
other: no effects on cornea observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Reversibility:
other: no effects on iris obserded
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Reversibility:
fully reversible within: 7days

Any other information on results incl. tables

No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours.

Moderate iritis (grade 1) was observed in two animals 1 hour after application only. All animals revealed slight conjunctival redness (grade 1) at hour 1 after application, which increased to moderate conjunctival redness (grade 2) at hour 24 and persisted in one of these animals until hour 48, followed by slight conjunctival redness (grade 1) at hour 72. The other two animals showed slight conjunctival redness (grade 1) from hour 48 until hour 72.

All animals showed moderate conjunctival chemosis (grade 2) at hour 1, which persisted in one of these animals until hour 24 and regressed to slight conjunctival chemosis (grade 1) at hour 48. The other two animals showed slight conjunctival chemosis (grade 1) from hour 24 until hour 72.

Obvious discharge (grade 2) was noted in all animals 1 hour after application and persisted in one of these animals until hour 24. The other two animals revealed slight discharge (grade 1) at hour 24.

Additional findings like desquamation of corneal epithelium and injected scleral vessels in a circumscribed or circular area were noted in the animals within 48 or 72 hours after application.

The ocular reactions were reversible in all animals within 7 days after application

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information