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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:
22 October 1998 to 10 February 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research, Kalamazoo, MI
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 2081 to 2664 g
- Housing: housed individually in suspended metal cages with perforated floors measuring 45.5 cm high, 76 cm wide and 60.5 cm deep (floor area 4598 cm2). The cage size is in compliance with animal welfare guidelines. Absorbent cage liners were placed in the pan below the metal mesh floor of the animal cages to absorb liquids
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days (screen animal), 27 days (additional two animals)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22.5
- Humidity (%): 43-78
- Air changes (per hr): ~18
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
Three days (i.e. no washing)
Observation period (in vivo):
Three days
Number of animals or in vitro replicates:
Three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: Draize JH Appraisal of the Safety of Chemicals in Foods, Drugs & Cosmetics, Assoc. Food & Drug Officials of the USA, Austin, TX; 1959 (see attached document for more details)


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: One hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: redness (transient hyperaemia of blood vessels)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: all (1 hour, 1,2 and 3 days)
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: no signs of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: One hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: redness (transient hyperaemia of blood vessels)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all (1 hour, 1, 2 and 3 days)
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all (1 hour, 1, 2 and 3 days)
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no signs of irritation
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: all (1 hour, 1, 2 and 3 days)
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: very slight conjunctival irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: all (1 hour, 1, 2 and 3 days)
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: no signs of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: all (1 hour, 1, 2 and 3 days)
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: very slight conjunctival irritation
Irritant / corrosive response data:
A single instillation of 0.1 ml Dow Corning 200 (R) Fluid 1.5 cSt, into the eye of the rabbit elicited transient hyperaemia of the blood vessels of the conjunctivae in two animals. Ocular reactions had resolved completely in both animals by one day after instillation. There were no signs of irritation in the third animal.
Other effects:
No deaths occurred during the study. No clinical signs of systemic reaction to treatment were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Under the conditions of this study, conducted according to EPA OPPTS guideline 870.2400 (Acute Eye Irritation) and to GLP, 0.1 ml Dow Corning 200(R) Fluid 1.5 cSt instilled into the eyes of rabbits elicited very slight transient conjunctival irritation in two of three animals. The test material was considered to be not irritating to eyes.
Executive summary:

In a GLP study conducted according to US EPA Health Effects Test Guideline OPPTS 870.2400 (Acute Eye Irritation), 0.1 ml Dow Corning 200® Fluid, 1.5 cSt was administered to the lower lid of one eye of one female rabbit. This was performed in advance of the similar dosing of a further two females to ensure that if a severe response was produced, no further animals would be exposed. All animals were observed over three days, and scored for eye irritation at 1 hour, and 1,2 and 3 days after instillation.

There was no evidence of systemic toxicity in any of the animals following treatment. Transient hyperaemia of conjunctival blood vessels was observed in two rabbits, and resolved completely within 24 hours. No other signs of eye irritation were observed in any treated animal.

Under the conditions of this study, Dow Corning 200® Fluid, 1.5 cSt was non-irritating to the eyes of rabbits according to EU criteria.