Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
The study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Very few details given in study report
Weight of animals at study initiation: 2.3 to 3.0 kg

Test system

Vehicle:
other: The test substance was applied unchanged or as a 30% solution in peanut oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% (undiluted) or 30% in peanut oil

Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
six animals per concentration
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Test substance was not removed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: no information

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean of 24, 48 and 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No effects observed in any animal at any timepoint
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed in any animal at any timepoint

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2,2,4,4,6,6-Hexamethylcyclotisilazane has been tested in a study conducted according to a protocol similar to OECD 405, prior to the adoption of OECD GLP guidelines. Application of 0.1 ml of undiluted test substance to the eyes of six New Zealand white rabbits resulted in conjunctival scores (mean of 24, 48 and 72 hours) of between 0 (two animals) and 1.67 (one animal). Chemosis scores (mean of 24, 48 and 72 hours) were between 0 (2 animals) and 0.67 (2 animals). No effects on iris or cornea were observed in any animal at any timepoint. It is concluded that the test substance is not irritating to the eye.