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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-08-12 - 2009-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 405, dated 24. April 2002 and ICCVAM recommended test method protocol dated November 2006
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: chicken's eggs
Strain:
other: Leghorn

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
mean 291.7 mg
Duration of treatment / exposure:
300 seconds
Observation period (in vivo):
300 seconds
Number of animals or in vitro replicates:
6 chicken's eggs

Results and discussion

In vivo

Results
Irritation parameter:
other: Mean Irritation Score
Basis:
mean
Time point:
other: 301 seconds
Score:
0
Max. score:
21
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This in vitro study was performed to assess the irritating potential of pleonastic spinel by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution) and sodium hydroxide (0.1-N solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation.
The value for sodium hydroxide solution was slightly out of the range of the historical data, this was considered as uncritical, because the positive control showed severe irritation and the deviation was only marginal (0.03 points outside the range of the historical data).
The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as "not irritant".
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
Executive summary:

This in vitro study was performed to assess the irritating potential of pleonastic spinel by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sul­fate (1% solution) and sodium hydroxide (0.1-N solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation.

The value for sodium hydroxide solution was slightly out of the range of the historical data, this was considered as uncritical, because the positive control showed severe irritation and the deviation was only marginal (0.03 points outside the range of the historical data).

The test item was tested pure. A mean irritation score of 0.0 was calculated, correspond­ing to a classification as "not irritant".

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.