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Administrative data

Description of key information

Skin irritation (U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-5): not a skin irritant
Eye iritation (U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-4): not an 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.
Qualifier:
according to guideline
Guideline:
other: U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-5.
GLP compliance:
yes
Remarks:
No further information was provided in the SNIF file.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Maximum duration of effect: 14 days. Maximum score at the end of the observation period: 1
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Reversibility of any observed effects: Changes not fully reversible within 14 days.
Other effects:
No unusual necropsy results.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Annex VI of DSD (67/548/EEC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient for
classification.
According to Annex I of CLP (1272/2008/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient
for classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-4.
GLP compliance:
yes
Remarks:
No further information was provided in the SNIF file.
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 mL
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 10d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
10d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7d
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effects: Changes fully reversible within 10 days.
Other effects:
No other effects.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the findings at 24h, 48h, 72h, and 7d, the test substance was scored to be mildly irritatant to the rabbit eye (Method of Kay and Colandra).
According to Annex VI of CLP (1272/2008/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol does not warrant classification for eye irritation.
Executive summary:

GST did not show any corneal or iris irritations in the study. The animals reacted with a conjunctival involvement in the way of discharge (1h, 3h and 24h evaluations) and scleral and conjunctival redness (until day 4). Five of six animals showed conjunctival rednedd at 24h after instillation, but only one animal exhibited conjunctival redness at at 48h. This may be interpreted as a result of the eyes' washing after the 24h evaluation. It then became a little worse at 72h and day 4 observations (3/6 animals showed reactions in the treated eyes) but on day 10, no irritation was observed in any eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation potential of 2,3 -bis((2-mercaptoethyl)thio)-1-propanethiol on skin was evaluated in an in vivo study, which was performed under GLP according to U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81 -5 (Mitsui 1993, SNIF#001-4.1.50 -01). Six New Zealand White rabbits were treated with 0.5 mL of the undiluted test substance under semiocclusive conditions for 4 hours, and then observed for 14 days. The resulting mean scores for edema and erythema indicated some irritation, though not reaching a severity that requires classification.

Eye irritation:

The acute eye irritation potential of 2,3 -bis((2-mercaptoethyl)thio)-1 -propanethiol was assessed in an in vivo study performed under GLP according to U.S. EPA Pesticide Assessment Guidelines, Subdivision F, Part 81 -4 (Mitsui 1993, SNIF#001 -4.1.60 -01). 0.1 mL of the test substance (concentration not specified) was instilled into one eye each of 6 New Zealand White rabbits and reactions were observed up to at least 10 days. The conjunctival erythema and chemosis reactions observed after exposure were minor and reversible. Therefore, the substance is not considered to be an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

According to Annex I of DSD (67/548/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient for classification.

According toAnnex VI of CLP (1272/2008/EC), the available data on 2,3-bis((mercaptoethyl)thio)-1-propanethiol are conclusive but not sufficient for classification.