Registration Dossier
Registration Dossier
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EC number: 411-290-7 | CAS number: 131538-00-6 MR-7 B; MR-8 B2; MR-S2
Endpoint summary
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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
