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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:
1999/06/21 - 1999/06/24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Charles River Nederland, The Netherlands

- Age at study initiation: at least 6 weeks old

- Weight at study initiation: 1223g, 1559g, 1569g (each)

- Housing: Individually housed in labelled cages with perforated floors.

- Diet: standard laboratory rabbit diet, ca. 100g/day

- Water: tap water, ad libitum

- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21

- Humidity (%): 50

- Air changes (per hr): ca.15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): undiluted


Duration of treatment / exposure:
Single instillation.
Observation period (in vivo):
Observations were made after 1, 24, 48 and 72 hours after instillation.
Number of animals or in vitro replicates:
3M
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): solution of 2% fluorescein in water was instilled in both eyes of each animal to quantitatively determine corneal damage

- Time after start of exposure: 24h


SCORING SYSTEM: According to guideline.


TOOL USED TO ASSESS SCORE: fluorescein/opthalmic examination lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks on result:
other: no information available
Irritation parameter:
iris score
Remarks on result:
other: no information available
Irritation parameter:
conjunctivae score
Remarks on result:
other: no information available
Irritant / corrosive response data:
Instillation of the test substance resulted in irritation of the conjunctivae, which was seen as redness. The irritation had completely resolved within 24 hours in all animals. No irridial irritation, corneal epithelial damage or corneal opacity were observed in any of the animals.
Other effects:
There was no evidence of ocular corrosion, no staining or peri-ocular tissues by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating as determined in a reliable study conducted according to an appropriate test protocol and in compliance with GLP.