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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:
from 2 May 2000 to 4 july 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study to GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostaphat B 310 roh (Tributoxyethylphosphate, TBEP)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg
- Age at study initiation: no data
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.89
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
3
Reversibility:
fully reversible within: 7 days
Other effects:
Clear colourless discharge was observed in all animals, persisting to 48 hours in one animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
TBEP was found to be slightly irritating to New Zealand White rabbits. Under the conditions of this study, TBEP would not be classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or EU GHS.
Executive summary:

Twenty four hours before the start of the study, the test eyes of all animals were examined for corneal lesions under UV light. Only animals without ocular lesions were used in the study. Undiluted TBEP (0.1 ml) was administered once to the conjunctival sac of the left eye of three rabbits. The untreated right eyes served as controls. 24 hours after administration, the treated eyes were washed with warm isotonic saline. The eyes were examined at 1, 24, 48 and 72 hours. At 24, 72 hours and 7 days, eyes were also examined for corneal lesions under UV light. Lesions in cornea, iris or conjunctiva were scored numerically.

One hour up to 72 hours, the treated conjunctivae showed beefy-red blood vessels and slight to moderate swelling. From 24 to 48 hours, the iris of one animal was reddened. Diffuse translucent areas of the cornea were observed one hour after administration in two animals, persisting to72 hours in one animal. Clear colourless discharge was observed in all animals, persisting to 48 hours in one animal. All signs of irritation had resolved at 7 days.

 Under the conditions of this study, TBEP was considered not irritating to eyes..