Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: ECVAM DB-ALM INVITTOX Protocol 96
Deviations:
not applicable
Remarks:
The study was performed before the publication of the protocol, even though it is fully compliant.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Details on test animals or tissues and environmental conditions:
Hen's egg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
1 min and 3 min
Number of animals or in vitro replicates:
1 egg - 1 min
3 eggs - 3 min
Details on study design:
The present study refers to the same publication referred into the Invittox protocol:
Spielmann et al. (1991). Interlaboratory assessment of alternatives to the Draize eye irritation test in Germany. Toxic.in vitro 5(6) 539-542

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Haemorrhagia
Value:
ca. 1
Irritation parameter:
other: Lysis
Value:
ca. 0
Irritation parameter:
other: Coagulation
Value:
ca. 2.3

In vivo

Irritant / corrosive response data:
Score is based on the addition of the three effects. Total score is: 3.3.
Grading of effects observed after test substance removal by washing.

Any other information on results incl. tables

Grading:

0 = no reaction

1 = slight

2 = moderate

3 = severe

Applicant's summary and conclusion

Interpretation of results:
other: Eye Irrit. 2 based on CLP Regluation (EC no. 1272/2008)
Conclusions:
Ca(H2PO2)2 may cause severe eye damage.
Executive summary:

Calcium hypophosphite was analysed in vitro with the HET-CAM in vitro corrosion test. This is an accepted methods that is based on the effect of the test item on hen's eggs.

The final score is the sum of the effects on haemorragia, Lysis and coagulation.

Final score after 3 min is 3.3 which corresponds to severe eye irritant.