Registration Dossier

Administrative data

Description of key information

Di-tert-dodecyl polysulfides is slightly irritating to skin and eyes.

Skin irritation
In a study similar to OECD TG 404, primary skin irritation in rabbits was evaluated for polysulfides, di-tert-dodecyl (Guillot, 1986b). Six rabbits (strain not specified) were exposed to undiluted di-t-dodecyl polysulfide under semi-occlusive conditions for four hours. Slight erythema was noted in one rabbit, and moderate erythema was noted in five rabbits. Slight edema was noted in three of six rabbits. Mean scores over 24, 48 and 72h were 1.72 for erythema and 0.39 for edema. Polysulfides, di-tert-dodecyl was considered as slight skin irritant.

Eye irritation
In a study similar to OECD TG 405, primary eye irritation was evaluated for polysulfides, di-tert-dodecyl (Guillot, 1986c). 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. Polysulfides, di-tert-dodecyl was considered as a slight eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48 and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure:
- Surface of coverage: 6 cm²
- Type of wrap if used: wide perforated tape applied on a crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize scale
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.72
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
TPS 32 produced a slight erythema in one rabbit and a moderate erythema  in 5 rabbits.  A slight oedema was observed in 3 rabbits. 

See attached document

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
Di-t-dodecyl polusulfides was considered as slightly irritating for the skin.
Executive summary:

In a study similar to OECD TG 404, primary skin irritation in rabbits was evaluated for di-t-dodecyl polysulfides (TPS 32). Six rabbits (strain not specified) were exposed to undiluted di-t-dodecyl polysulfide under semi-occlusive conditions for four hours. Slight erythema was noted in one rabbit, and moderate erythema was noted in five rabbits. Slight edema was noted in three of six rabbits. Mean scores over 24, 48 and 72h were 1.72 for erythema and 0.39 for edema. Di-t-dodecyl polusulfides was considered as slightly irritating for the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
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
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

See attached document

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the available data and criteria of regulation no. 1272/2008, no classification is warranted for skin, eye and respiratory tract irritation.