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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.364 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
36.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
It is assumed that oral and dermal absorption rates are equal.
AF for differences in duration of exposure:
2
Justification:
DNEL is based on an oral 90 day study
AF for interspecies differences (allometric scaling):
4
Justification:
experimental animal was rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

No subchronic studies are available for GMT. The first step in GMT metabolism is the hydrolysis of its ester bonds resulting in glycerol and mercaptoacetate. Long-term exposure, dermal, systemic effect DNEL was therefore based on a subchronic oral toxicity study performed in rats with the toxicological most relevant metabolite mercaptoacetate (sodium salt, NaTG). In this study a subchronic oral NOAEL of 20 mg/kg bw /day was found. This refers to an equimolar NAEL of 36.4 mg/kg bw/day based on the molecular weight ratio and the level of esterification.

Calculation of NAEL: NAEL= (NOAEL x MW GMT/ MW NaTG)/ level of esterification

MW GMT: 166.2 g/mol

MW NaTG: 114.1 g/mol

Level of esterification of glycerol with mercaptoacetic acid: 80%

Judging from the ratio of oral to dermal LD50 values (177vs 2000 mg/kg bw), the dermal absorption of GMT is predicted to be low, therefore a factor of 0.1 was added for dermal absorption.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.182 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
36.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
It is assumed that oral and dermal absorption rates are equal.
AF for differences in duration of exposure:
2
Justification:
based on an oral 90 day study
AF for interspecies differences (allometric scaling):
4
Justification:
experimental animal was rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
182 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
36.4 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
based on an oral 90 day study
AF for interspecies differences (allometric scaling):
4
Justification:
experimental animal was rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No subchronic studies are available for GMT. The first step in GMT metabolism is the hydrolysis of its ester bonds resulting in glycerol and mercaptoacetate. Long-term exposure, dermal, systemic effect DNEL was therefore based on a subchronic oral toxicity study performed in rats with the toxicological most relevant metabolite mercaptoacetate (as NaTG).

In this study a subchronic oral NOAEL of 20 mg/kg bw /day was found. This refers to an equimolar NAEL of 36.4 mg/kg bw/day based on the molecular weight ratio and the level of esterification.

Calculation of NAEL: NAEL= (NOAEL x MW GMT/ MW NaTG)/ level of esterification

MW GMT: 166.2 g/mol

MW NaTG: 114.1 g/mol

Level of esterification of glycerol with mercaptoacetic acid: 80%

Judging from the ratio of oral to dermal LD50 values (177 vs 2000 mg/kg bw), the dermal absorption of GMT is predicted to be low, therefore a factor of 0.1 was added for dermal absorption.