Registration Dossier
Registration Dossier
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EC number: 224-226-6 | CAS number: 4253-90-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Di-tert-butyl trisulphide
- EC Number:
- 224-226-6
- EC Name:
- Di-tert-butyl trisulphide
- Cas Number:
- 4253-90-1
- Molecular formula:
- C8H18S3
- IUPAC Name:
- di-tert-butyltrisulfane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle (80160 Prouzel, France)
- Age at study initiation: no data
- Weight at study initiation: 2.7 +/- 0.01 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): Rabbits sustenance 112 C (UAR, 91360 Villemoisson/Orge, France)
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- up to 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
A single dose of 0.1 ml of the test substance in its original form was instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. The eyes were not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation. The mean score of the scores recorded after 24, 48 and 72 hours for each animal was calculated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1; #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Some slight conjunctival reactions (chemosis and redness: mean score <= 0.3 in all 3 animals) were observed after instillation of the test substance. No iridic irritation or corneal opacity was noted. No ocular reactions were observed after 48 and 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TPS 44 was considered as very slightly irritant when administered by ocular route in rabbits.
- Executive summary:
The ocular irritation that could be induced by di-tert-butyl polisulfides (TPS 44) was evaluated in rabbits according to the recommendations of the OECD Guideline No. 405 and GLP. Having confirmed that TPS 44 did not have a very irritant or corrosive effect when administered by cutaneous route, a single dose of 0.1 ml of TPS 44 in its original form was instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. The eyes were not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation. The mean score of the scores recorded after 24, 48 and 72 hours for each animal was calculated. Some slight conjunctival reactions (mean chemosis score of 0.3 in 2 animals and mean redness score of 0.3 in 2 animals) were observed after instillation of the test substance. No iridic irritation or corneal opacity was noted. No ocular reactions were observed after 48 and 72 hours. TPS 44 was considered as very slightly irritant when administered by ocular route in rabbits.
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