Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU Method B.5 and OECD 405).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
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:
- Name of test material (as cited in study report): Ethyoxypropyl Acetate
- Physical state: Liquid
- Analytical purity: > 98.5%
- Storage condition of test material: At ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
- Source: Rosemead Rabbits, Rosemead, Essex, UK
- Age at study initiation: Approximately 10 to 12 weeks
- Weight at study initiation: 2.2 – 2.7 kg
- Housing: Individually in metal cages with perforated floors
- Diet: Ad libitum access to SDS Standard Rabbit Diet
- Water: Ad libitum access to tap water
- Acclimation period: Animals were acclimated to the laboratory environment (period not stated)

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 degrees C
- Humidity: 30 – 70 % relative humidity
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light (0700-1900 hours) in each 24 hour period.


IN-LIFE DATES: From: 5 August, 1985 To: 12 August, 1985.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye of each animal remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml was placed into the everted lid of one eye of each animal.
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4, and 7 days after instillation.
Number of animals or in vitro replicates:
Two males and one female
Details on study design:
SCORING SYSTEM:
Cornea (Grade 0 – 4)
Iris (Grade 0 – 2)
Conjunctiva Redness (Grade 0 – 3)
Conjunctiva Chemosis (Grade 0 – 4)
Other lesions described

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72hr
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72hr
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
No corneal damage or iridial effect was observed in any animal at any time point. Maximum scores of Grade 2 redness (a diffuse crimson red colouration) and Grade 1 chemosis were observed in the conjuctiva of all three animals 1 hour following treatment. These changes were resolved in all animals by Day 3 following treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Grade 2 conjuctival redness was classified as a positive response in this study. On the basis of this finding all three animals were considered to have produced a positive response to ethoxypropyl acetate. The overall mean irritation scores at 24, 48 and 72 hours were not sufficient to require labeling under Annex VI of EEC directive 67/548/EEC with the risk phrase R36: ‘Irritating to Eyes’.
Executive summary:

In an guideline and GLP in vivo rabbit eye irritation study (without washing at 24hrs), administration of 0.1 ml of ethyoxypropyl acetate produced maximum scores of Grade 2 redness and Grade 1 chemosis one hour following treatment.  These changes were resolved in all animals by Day 3.  No corneal damage or iridial inflammation was observed. The level of transient irritation produced was insufficient to meet the requirement for classification as an eye irritant.