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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
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

Constituent 1
Chemical structure
Reference substance name:
Polysulfides, di-tert-Bu
EC Number:
273-103-3
EC Name:
Polysulfides, di-tert-Bu
Cas Number:
68937-96-2
Molecular formula:
not applicable
IUPAC Name:
Polysulfides, di-tert-Bu
Details on test material:
Source: SNEA(P), CAT/Lacq
Batch 917187
Sulfur content 45.2%.

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.