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Diss Factsheets

Administrative data

Description of key information

Based on LLNA data supported by read-across from a GPMT with GMT, monothioglycerol is considered a moderate skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2010
Deviations:
yes
Remarks:
TS not characterised
Principles of method if other than guideline:
LLNA with pre-guidleine methodology
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
purchased from Fluka
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
Age: 8-12 wk
Vehicle:
dimethylformamide
Concentration:
10.0%, 25.0%, 50.0%
No. of animals per dose:
4
Details on study design:
Mice received daily topical application for 3 consecutive days with 25 µL of one of three concentrations of the test chemical on the dorsum of each ear. Control mice were treated with vehicle alone in an identical manner. 5 days after the first topical application, all mice were injected iv with 250 µL PBS containing 20 µCi of [³H]methyl thymidine
Positive control substance(s):
not specified
Positive control results:
not required
Key result
Parameter:
EC3
Value:
3.9
Test group / Remarks:
Interpolated from the SI values at 0%, 10%, and 25%
Key result
Parameter:
SI
Value:
6.7
Test group / Remarks:
10.0%
Parameter:
SI
Value:
10
Test group / Remarks:
25.0%
Parameter:
SI
Value:
10
Test group / Remarks:
50.0%

TG was also positive in 100% of participants in a human maximization test using 10% and 5% TG for induction and challenge, respectively.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
TB showed an EC3 of ca. 4%. It is therefore considered a moderate skin sensitizer (Skin Sens 1B).
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
see attached justification
Reason / purpose for cross-reference:
read-across source
Type of study:
guinea pig maximisation test
Species:
guinea pig
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- Intradermal induction : 1% w/v of the supplied test material in distilled water
- Topical lnduction : 10% v/v of the supplied test material in distilled water
- Topical Challenge : 10% and 5% v/v of the supplied test material in distilled water
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- Intradermal induction : 1% w/v of the supplied test material in distilled water
- Topical lnduction : 10% v/v of the supplied test material in distilled water
- Topical Challenge : 10% and 5% v/v of the supplied test material in distilled water
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % v/v
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
erythema and oedema formation up to score of 2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % v/v. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema formation up to score of 2.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % v/v
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
erythema and oedema formation up to score of 2, desquamation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % v/v. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema formation up to score of 2, desquamation.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% v/v
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no erythema or edema, only slight desquamation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema, only slight desquamation.
Reading:
other: incidence of sensitisation
Group:
positive control
Dose level:
25% MBT in acetone PEG 400 (70:30)
No. with + reactions:
9
Total no. in group:
10
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on read across from GMT, TG is considered a moderate sensitizer to guinea pig skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

TG was also positive in 100% of participants in a human maximization test using 10% and 5% TG for induction and challenge, respectively.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

TG had an EC3 of > 2% in an LLNA. The surrogate substance GMT had 50% responding animals in a GPMT at 1% intradermal induction dose. Therefore, TG is classified as moderate skin sensitizer (Skin Sens 1B)