Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 January 1987 to 29 January 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were: maximum temperature may have been very slightly higher than recommended (24 vs 23 °C). It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature of 22 ± 2 °C (20 ± 3 °C recommended)
Qualifier:
according to
Guideline:
other: 84/449/EEC
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DEGUSSA-Silane Si 264 (3-Thiocyanatopropyltriethoxysilan)
- Substance type: no data
- Physical state: colourless liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: Wi 12083 (dest.)
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: Solubility: hardly soluble in water

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 6 to 7 months
- Weight at study initiation: 2.40 to 2.85 g
- Housing: singly in stainless steel cages type ASTA
- Diet (e.g. ad libitum): standard diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 January 1987 To: 23 January 1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each animal left untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
3 days
Observation period (in vivo):
3 days (at 1, 24, 48 and 72 hours after application)
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize system (see "Any other information on materials and methods incl. tables")

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
4
Remarks on result:
other: No observable effect in any animal at any timepoint
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
2
Remarks on result:
other: No observable effect in any animal at any timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 hour
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: individual scores 2,2,1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: individual scores 1,2,0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48 hours and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: individual scores 0,0,0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: individual scores 1,2,0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual scores 0,0,0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 1 hour
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: individual scores 1,0,0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: individual scores 0,0,0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
evaluation score (sum of three endpoints, multiplied by 2) - mean over all timepoints
Time point:
other: all
Score:
2
Max. score:
20
Reversibility:
fully reversible within: 48 h
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
sum of evaluation scores for three eye sections - mean over all timepoints
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: See "Any other information on materials and methods incl. tables" for information on derivation
Irritant / corrosive response data:
There were no observable effect on the cornea or iris.
Hyperaemia or redness (grade 1 or 2) was seen in the conjunctiva at 1 and 24 h after application. This was resolved within two days of application.
Slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) each occurred in one animal within one hour of treatment, and resolved within 24 hours.
Slight discharge was noted in one animal within one hour of application only.
Other effects:
There were no overt signs of systemic toxicity or mortality over the duration of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study carried out to OECD Test Guideline 405, Si 264 (triethoxy(3-thiocyanatopropyl)silane) was non-irritating when applied undiluted to the eyes of rabbits.
Executive summary:

In a study carried out in accordance with OECD Test Guideline 405, Si 264 (triethoxy(3-thiocyanatopropyl)silane) was tested for its potential to cause eye irritation in rabbits.

0.1 ml of the undiluted test material was applied to one eye of each of three rabbits (two males and one female), with the other eye left as an untreated control. Observations were made 1, 24, 48 and 72 hours after application.

 

There were no overt signs of systemic toxicity or mortality throughout the course of the study. Application of Si 264 had no apparent effect on the cornea or iris. Conjunctival redness and hyperaemia was observed in all treated animals within 24 hours, and was fully resolved within 48 hours. Slight swelling and discharge was seen in the treated eye of one animal, and swelling with partial eversion of lids was seen in another. These effects were only evident during the first 24 hours following application.

 

An overall irritation index of 2 was calculated and the test material was considered to be non-irritation to eyes (according to Draize criteria) under the conditions of the test. It would not be classified as an eye irritant by EU criteria.