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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
Study period:
1996-10-03 to 1996-10-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study, tested with the source substance Zeolite, cuboidal, crystalline, synthetic, non fibrous. According to the ECHA Guidance Document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Siliporite G 5100
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Chemical name: aluminosilicate
- Analytical purity: no data
- Lot/batch No.: MR/109/240
- surface modified with Li/rare earth elements

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg
undiluted
Duration of treatment / exposure:
168 h
Observation period (in vivo):
Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were calculated.
Number of animals or in vitro replicates:
3
Details on study design:
As no severe irritant effects were anticipated, a single dose of 100 mg of the test substance was introduced into the left conjunctival sac of three male New Zealand White rabbits. The right eye served as control.
The test substance was ground to a fine powder. The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately one hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Very slight to marked conjunctival reactions were noted between day 1 and day 6: very slight to marked chemosis, very slight to marked conjunctival redness and clear ocular discharge.
Slight iritis was observed on day 3 in two animals; it persisted for 48 hours in one of them.
Very slight or slight corneal opacity was also noted in all animals on day 2; it persisted for 24 hours in one animal, and for 48 hours in two animals.
Reversibility of ocular lesions was noted on day 5 in two animals, and on day 7 in the other one.
The mean scores calculated over 24, 48 and 72 hours were 2.7, 0.7 and 0.7 for chemosis, 2.7, 0.3 and 1.3 for redness of the conjunctiva, 1.0, 0.0 and 0.3 for iris lesions and 1.7, 1.0 and 0.7 for corneal opacity.
Criteria for irritation: significant severe ocular lesions caused within 72 hours after exposure and which persists for 24 hours or more.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information