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
Study period:
1993/05/03-1993/05/07
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

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white ChBB:HM, SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1.

- Weight at study initiation: 2.3-2.6 kg

- Housing: Animals were individually caged in stainless steel cages.

- Diet: Ssniff K 4 Comprehensive Rabbit Chow (ad libitum) Ssniff Specialfoods GmbH, 59494 Soest.

- Water: ad libitum

- Acclimation period: Minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 cm3 of the liquid test material was applied in the conjunctival sac of the right eye of each animal


Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Washing (if done): Washing was carried out with a sodium chloride solution of body temperature.

-Time after exposure: 24 hours


SCORING SYSTEM: Draize 1959.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Irritant / corrosive response data:
A single instillation to the rabbit eye produced minimal conjunctival irritation in the three animals at one hour post exposure. The adverse effect was completely reversed by 48 hours.
Other effects:
No other effects reported.

Any other information on results incl. tables

Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

1/0/0 

1/1/1 

 1/1/1

24 h

 0/0/0

0/0/0 

1/0/0 

 0/0/0 

48 h

 0/0/0

0/0/0

 0/0/0

 0/0/0

72 h

 0/0/0

       0/0/0

 0/0/0

 0/0/0

Reversibility*)

 -

Average time (unit) for reversion

 

 24h

24h 

24h

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a reliable study conducted in accordance with OECD 405 and in compliance with GLP, 3-chloropropyltrimethoxysilane was found to be non-irritant to rabbit eyes.