Registration Dossier
Registration Dossier
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EC number: 252-161-3 | CAS number: 34708-08-2
Toxicological information
Eye irritation
Currently viewing:
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:
- 1 987
- 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
- 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-(cyanosulfanyl)propyl]triethoxysilane
Constituent 1
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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