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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles; however, the test was not performed until reversibility of effects (conjunctival redness).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Department of Transportation, Code of Federal Regulations, Title 49, part 173
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
930-915-9
EC Number:
930-915-9
IUPAC Name:
930-915-9
Details on test material:
- Name of test material (as cited in study report): Code 504 Can #19a
- Related CAS number: 1318-02-1
- Physical state: white fine powder
- Analytical purity: no data
- surface modified with approx. 10% rare earth elements

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg (powder), undiluted
not rinsed
Duration of treatment / exposure:
72 h
Number of animals or in vitro replicates:
6
Details on study design:
Following a 7 day acclimation, the rabbits (New Zealand Albinos) were screened for ocular irritation by pen light examination. This was followed by fluorescein staining and observation of the cornea using an ultra-violet lamp. A 100 mg (powder) sample was instilled into the conjunctival sac of one eye of each of 6 rabbits. The opposite eye remained untreated and served as the control. The eyes were examined at 24, 48 and 72 hours and graded for irritation according to the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1
Reversibility:
not fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.3
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3-6
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24-72 h
Score:
0
Irritant / corrosive response data:
No findings were recorded concerning cornea and iris. Conjunctivae of 2/6 animals revealed slight redness at observation day one. This slight redness was lasting in one animal until observation day 3. Chemosis of the conjunctivae was not observed in all 6 test animals.
The test substance would not be considered an ocular irritant under the conditions of this test.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information