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Description of key information

In the guinea pig maximisation test 1,3-propanesultone was not sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
other: Induction: FCA (intradermal), liquid paraffin (epicutaneous)
Concentration / amount:
Intradermal induction: 1% in FCA
Epicutaneous induction: 1% in liquid paraffin
Day(s)/duration:
1 single injection and after one week 48 h epicutaneous occlusive application
Adequacy of induction:
not specified
Route:
other: epicutaneous, closed patch or open application
Vehicle:
other: EtOH
Concentration / amount:
Epicutaneous challenge: 2% and 0.1% in EtOH
Day(s)/duration:
two weeks after epicutaneous induction for 24 h
Adequacy of challenge:
not specified
No. of animals per dose:
5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 1 single injection and after one week 48 h epicutaneous occlusive application
- Test groups: injection: 0.1 mL FCA, 0.1 mL test substance, 0.1 mL test substance in FCA, epicutaneous: in petrolatum
- Control group: injection: 0.1 mL FCA, 0.1 mL vehicle, 0.1 mL vehicle in FCA, epicutaneous: in petrolatum
- Site: rectangle area (scapular region)
- Frequency of applications: one application each


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: two weeks after epicutaneous induction
- Exposure period: 24 h
- Test groups and control group: closed patch or open epicutaneous
- Site: back
- Evaluation (hr after challenge): 24 h and 48 h

Challenge controls:
no
Positive control substance(s):
yes
Remarks:
test included various 1-alkyl-1,3-propione sultones
Positive control results:
The 1-alkyl-1,3-propane sultones tested concurrently were positive, indicating the sensitivity of the test system.
Reading:
other: only combined reading (24 h and 48 h) reported
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
5
Reading:
other: only combined reading (24 h and 48 h) reported
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
other: only combined reading (24 h and 48 h) reported
Hours after challenge:
48
Group:
negative control
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Reading:
other: only combined reading (24 h and 48 h) reported
Hours after challenge:
48
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a dermal sensitisation study (Morikawa et al., 1978) with the test item guinea pigs were tested using the method of Magnusson and Kligman (induction treatment: 1% given intracutaneously, 1% given epicutaneously; epicutaneous challenge treatment: 2%). In this study 0% of the animals treated showed a skin sensitization response.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result of the guinea pig maximisation test, 1,3-propanesultone is not subject to classification and labelling according to CLP (Regulation 1272/2008/EC).