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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:
20 January 1987 to 29 January 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature of 22 ± 2 °C (20 ± 3 °C recommended).
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(3-thiocyanatopropyl)silane
EC Number:
252-161-3
EC Name:
Triethoxy(3-thiocyanatopropyl)silane
Cas Number:
34708-08-2
Molecular formula:
C10H21NO3SSi
IUPAC Name:
3-(triethoxysilyl)propyl thiocyanate

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: standard diet ad libitum
- Water: 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:
Applied on day 1
Observation period (in vivo):
3 days (at 1, 24, 48 and 72 hours after application)
Number of animals or in vitro replicates:
1M, 2F
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:
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 hours
Remarks on result:
other: See "Any other information on materials and methods incl. tables" for information on derivation
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
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
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:
No observable effects on the cornea or iris were observed.
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:
GHS criteria not met
Conclusions:
In a study conducted according to OECD Test Guideline 405 but not in compliance with GLP (reliability score 2), triethoxy(3-thiocyanatopropyl)silane was non-irritating when 0.1 mL applied undiluted to the eyes of rabbits (one male, two females), with observations up to 72 hours. The mean individual 24/48/72-hour scores were 0 for the cornea, iris, and chemosis (all individual timepoint scores at 24-72 hours were 0). For conjunctival redness, the mean individual 24/48/72-hour scores were 0-0.66, and fully resolved in the two affected animals within 48 hours.

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