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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Polysulfides, di-tert-dodecyl
EC Number:
270-335-7
EC Name:
Polysulfides, di-tert-dodecyl
Cas Number:
68425-15-0
Molecular formula:
not applicable
IUPAC Name:
di (alkyl C11-C13 Branched, C12 Rich), polysulfure S3-S5 rich

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
Remarks:
Not eye irritating
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.