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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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: individual housing in polystyrene cages
- Diet (ad libitum): Rabbit complete pelleted maintenance food (UAR, France)
- Water (ad libitum): softened and filtered drinking wated
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- 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 rinced
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.61
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
TPS 32 induced a slight chemosis and/or enanthema which persisted for up to 72 hours in 2 animals

Any other information on results incl. tables

See attached document

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Di-t-dodecyl polysulfides is considered as a slight eye irritant.
Executive summary:

In a study similar to OECD TG 405, primary eye irritation was evaluated for di-t-dodecyl polysulfides (TPS 32). A 0.1 ml undiluted dose was instilled into one eye of six rabbits and irritation was scored at 1, 24, 48, and 72 hours. Di-t-dodecyl polysulfide induced a slight chemosis and/or enanthema, which persisted for up to 72 hours in two animals. Slight iridial congestion was observed up to 48 hours in some animals. Mean scores over 24, 48 and 72 h were 0.0 for corneal opacity, 0.33 for iris congestion, 0.89 for chemosis and 0.61 for enanthema. Di-t-dodecyl polysulfides is considered as a slight eye irritant.