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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
Study period:
07.09.1993 to 06.12.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,3,3,3-hexamethyldisilazane
EC Number:
213-668-5
EC Name:
1,1,1,3,3,3-hexamethyldisilazane
Cas Number:
999-97-3
Molecular formula:
C6H19NSi2
IUPAC Name:
bis(trimethylsilyl)amine
Details on test material:
- Name of test material (as cited in study report): Hexamethyldisilazane
No further details available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age:  Young male adult rabbits weighing between 2.7 and 2.85 kg
No further data - details taken from IUCLID 2008
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.7 to 2.85 kg
- Housing: Individually in stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: From: 26.10.1993 To: 29.10.1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
No washing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Fluorescein stain was used at the 24, 48, and 72-hour readings. Eyes were examined by slit illumination for ocular changes of the cornea, iris (internal effects) and conjunctiva.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See Table 1. The test material caused slight conjunctival hyperemia in two animals and slight conjunctival chemosis in one animal at the 1 hour reading; these reactions had subsided at the subsequent readings (2 or 24 hours). The primary eye irritation score was calculated for the animals to be 0 (non-irritating).
Other effects:
A very slight immediate pain response was observed in all animals. 

Any other information on results incl. tables

Table 1 Mean irritation scores

 Individual Tissue parameter  1 hour  2 hours  24 hours  48 hours  72 hours
 Corneal Opacity  -  -  0  0  0
 Iridial inflammation  0 0   0  0  0
 Conjunctival irritation               
 Redness  0.7  0  0  0  0
 Chemosis  0.3  0  0  0 0 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a reliability score 1 eye irritation study, which was conducted according to OECD Test Guideline 405 and in compliance with GLP, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3) was non-irritating to rabbit eyes.