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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 405 and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzylalkohol
- Purity: 99.99%
- Appearance: colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: albino rabbits, HC:NZW
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England, UK
- Age at study initiation: adult rabbits
- Weight at study initiation: 3.1-3.4 kg
- Housing: individually under standardized conventional conditions in stainless steel cages with perforated floors
- Diet: approx. 100-120 g/animal and day; feeding once per day in the morning
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of the respective animal served as control
Amount / concentration applied:
100 µl (ca 104.5 µg)
Duration of treatment / exposure:
24 hours (The treated eye was washed out 24 hours after instillation of the test compound)
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM:
as described by Draize

TOOL USED TO ASSESS SCORE:
hand-slit lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 d at the latest
Irritation parameter:
iris score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score: 0.3
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d at the latest
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: mean score: 0.7
Irritant / corrosive response data:
Exposure of the test substance to the eye resulted in irritant effects of the mucous membranes and the cornea. Being more pronounced immediately following administration signs persisted on day 14 in 2 animals but proved to be reversible after 3 weeks. According to the author these evidences indicate an irritant potential of the product to the eye.
Other effects:
With fluorescein slight and reversible epithelial effects in the cornea were seen.

Applicant's summary and conclusion

Executive summary:

According to OECD TG 405, 3 rabbits received a dose of 100 µl/animal into the conjunctival sac of one eye of each rabbit (the untreated eye served as control). Eyes were washed out 24 hours after start of exposure. The total post exposure period was 21 days. Benzyl alcohol was irritating to the eyes of rabbits, but full recovery occurred within the 21 days observation period (Bayer AG 1990).