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Diss Factsheets

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:
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Physical state: powder / grey-white
- Analytical purity: 95.8% (per weight; HPLC)
- Lot/batch No.: ZD 1151/ 31 (production: 03-Dec-1997)
- Storage condition of test material: refrigerator, protected from light.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG / Chbb: NZW (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.51 and 3.72 kg for the 2 females, 3.58 kg for the male
- Housing: The animals were single-housed in fully air-conditioned rooms in Stainless steel wire mesh cages with grating, floor area: 3000 cm2; animal identification: ear tattoo. No bedding in the cages; wood shavings in the waste trays.
- Diet, ad libitum: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day). The feed used in the study was assayed for chemical and microbiological contaminants. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Water, ad libitum: about 250 ml tap water per animal per day. The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Central air-conditioning guaranteed a range of 20 - 24 degrees
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours (6.00 am - 600 pm/ 6.00 pm - 6.00 am)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 30 mg of the comminuted test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
up to 28 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD guideline 405 (adopted February 24, 1987) and EEC directive 92/69, L 383A, B.5 (December 29, 1992).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
mean
Remarks:
from animal #1 and animal #3 (all female)
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
animal #2
Remarks:
male
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: observed from 48 hours after treatment
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
from animal #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: positive response observed in one treated animal
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1 and animal #3
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: observed from 24 hours after treatment
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: positive response observed in only one treated animal
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animals #1 and 2
Time point:
other: 24-48-72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: scores after 1 hour: 1/2 (animal #1/animal #2); 24 hours: 2/2; 48 hours: 1/1; 72 hours: 1/1; 7 days: 0/1; and 14 days: 0/0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24-48-72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: scores after 1 hour: 1; 24 hours: 2; and 48 hours: 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
from animals #1, #2 and #3
Time point:
other: 24-48-72 hours
Score:
1.1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: scores (animal #1/animal #2/animal #3) observed after 1 hour: 1/1/1; 24 hours: 0/2/1; 48 hours: 0/1/0; 72 hours: 0/1/0; and 7 days: 0/0/0;
Other effects:
conjunctiva discharge was observed in animal #3 after 24 hours (score: 1) and in animal #2 after 1 hour (1), 24 hours (2), 48 hours (1) and 72 hours (1). No other adverse effects were observed

Any other information on results incl. tables

One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
One animal still had corneal opacity grade 1 after 21 days but was free of symptoms after 28 days. The other 2/3 animals were free of symptoms after 7 days and did not show any corneal opacity at any time.