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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:
13-Nov-1996 to 21-Nov-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on 24-Feb-1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Description: off white solid
- Analytical purity: 99.4 %
- Storage: at room temperature, away from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, 88397 Biberach/Riss, Germany
- Age at study initiation: 15 weeks old
- Weight at study initiation: 2.8 kg (male), 2.9-3.0 kg (females)
- Housing: individually, in stainless steel cages
- Diet: pelleted standard rabbit maintenance diet (Kliba 341, Kliba Mühlen AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: 13-Nov-1996 to 21-Nov-1996

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single treatment, no washout performed
Observation period (in vivo):
at least 72 hours after the single treatment
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in Directive 92/69/EEC (according to Draize, 1959) at approximately 1, 24, 48 and 72 hour(s) after administration. Minimal score: 0, maximal score: 4 (corneal opacity, conjunctival chemosis), 3 (conjunctival redness) or 2 (iris lesions)

In addition, the primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Minimal score: 0, maximal score: 13

TOOL USED TO ASSESS SCORE:
Varta Cliptrix diagnostic lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: individual mean score
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: individual mean score
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: individual mean score
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
3
Remarks on result:
other: individual mean score
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: individual mean score
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
3
Remarks on result:
other: individual mean score
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(male)
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(female)
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
4
Remarks on result:
other: individual mean score
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0.44
Max. score:
13
Remarks on result:
other: calculated value
Irritant / corrosive response data:
Treatment with the test item resulted in a primary irritation score of 0.44. Slight redness and slight swelling of the conjunctivae as well as a slight watery discharge were noted in all animals after 1 hour. Hyperaemia of the scleral blood vessels was seen in one animal only at the 1 hour reading. The remaining 2 animals had slight reddening and slight swelling of the conjunctivae combined with slight watery discharge after 24 hours. All findings were reversible in these animals after 48 hours.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. No staining of the cornea, sclera or conjunctivae by the test item was observed. The body weight of the animals was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test material is considered to be not irritating to the rabbit eye.
Executive summary:

The primary irritation potential of the test article was investigated by an eye irritation study following OECD guideline 405 in compliance with GLP. 0.1g of the test article was instilled into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.44 (max. 13). Redness and swelling of the conjunctivae, as well as watery discharge were noted in all animals after one hour. Hyperemia of the scleral blood vessels was seen in one animal only after one hour. The remaining two animals had reddening and swelling of the conjunctivae combined with watery discharge after 24 hours. All findings were reversible after 48 hours. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. Based on the results of this study, the test material is considered to be not irritating to the rabbit eye.