Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only available as a brief summary report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted test material was placed in the eye(s) of each of six rabbits, and the eyes were rinsed after 24 hours and assessed for signs of inflammation over a period of a week.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Santicizer 261
- Lot/batch No.: DE 114
no further data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
One week
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: According to Federal Hazardous Substances Act (FHSA)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 6
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Affecting conjunctivae only, no effects on cornea or iris
Irritant / corrosive response data:
Immediately after removal of the test material, discomfort was slight. After ten minutes, slight erythema and copious discharge were noted, and at 1-hour post exposure slight erythema and moderate discharge were seen. No eye irritation was observed at 24, 48, 72, 120 and 168 hours after the end of exposure.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Slight eye irritation was seen shortly after undiluted Santicizer 261 was placed in the eyes of six rabbits for 24 hours, but this was no longer evident 24 hours later.
Executive summary:

Undiluted Santicizer 261 (0.1 ml) was placed in the eyes of six New Zealand albino rabbits, and removed after 24 hours (presumably by rinsing). The treated eyes were assessed for signs of irritation during the 7-day observation period, and the data scored according to the method of FHSA.

 

Immediately after the 24 hour exposure period, slight discomfort was observed. At 10 minutes and 1 hour after rinsing, slight erythema and slight to moderate discharge were seen, with an average irritation score of 6 out of a possible 110 when examined at 1 hour after rinsing. Eyes were apparently unaffected by treatment when examined 24, 48, 72, 120 and 168 hours after the end of the exposure period, giving an overall irritation score of 0 (average of scores assessed at 24, 48 and 72 hours after rinsing). The investigators classed the test material as non-irritating to the eyes of rabbits. Under EU CLP regulations, this study would indicate that Santicizer 261 is not irritating to the eyes.