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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:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

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

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): 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

Results
Irritation parameter:
overall irritation score
Time point:
other: mean of 24, 48 and 72 h
Score:
0
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
 Conjunctival irritation               
 Redness  0.7  0  0  0  0
 Chemosis  0.3  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a reliability score 1 eye irritation study, which was conducted according to OECD 405 and GLP, hexamethyldisilazane was non-irritating to rabbit eyes.

Classification: not irritating
Executive summary:

In a reliability score 1 eye irritation study summarised in IUCLID 2008, which was conducted according to OECD 405 and GLP, 0.1 ml undiluted hexamethyldisilazane was instilled into the into one eye of each of three New Zealand white rabbits, the contralateral eye remained untreated as a control. Both eyes of all rabbits were examined at one, two, 24, 48 and 72 hours post-instillation. A very slight immediate pain response was observed in all animals. 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).