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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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only brief summary data and results table available.

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 into the eye(s) of each of six rabbits, and subsequently removed after 24 hours. The eyes were assessed for signs of irritation 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 160
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: QE-29401

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. 1.43
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Affecting conjunctivae only, no effects on cornea or iris
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 8
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Affecting conjunctivae only, no effects on cornea or iris
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 4.3
Max. score:
110
Reversibility:
fully reversible within: 48 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, and at 10 minutes copious discharge was noted. The discharge was still evident at 1 hour and, to a lesser extent, 24 hours post-exposure. Slight erythema was seen at 1 and 24 hours, but all signs of irritation had cleared by 48 hours post-exposure.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight eye irritation and copious discharge were seen shortly after undiluted Santicizer 160 was placed in the eyes of six rabbits for 24 hours, but this was fully reversible within 48 hours. Although few details are available for this study (reliability 4), the results are considered adequate for assessment.
Executive summary:

Undiluted Santicizer 160 (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 and after 10 minutes copious discharge was noted. At 1 hour after removal of the test material, copious discharge and slight erythema were reported, giving a mean irritation score of 8 out of a possible 110. At 24-hours post-exposure, slight erythema and slight to moderate discharge were reported (mean irritation score of 4.3/110). All effects were on the conjunctivae. Eyes appeared normal when examined 48, 72, 120 and 168 hours after removal of the test material, giving an overall irritation score of 1.43 (average of scores assessed at 24, 48 and 72 hours post exposure). The investigators classed the test material as slightly irritating to the eyes of rabbits, but noted that it would not be classed as an eye irritant under FHSA. Similarly under EU CLP regulations, this study would indicate that Santicizer 160 is not an eye irritant.