Registration Dossier
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EC number: 204-815-4 | CAS number: 126-97-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.41 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- DNEL value:
- 52.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr=NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 700 mg/kg/d*(1/0.38 m³/kg/d)*(0.5*1)*0.67=617 mg/m³. It is assumed that oral absorption rate is 50% of that of inhalation absorption. ABSoral/rat=oral absorption rate in rats, ABSinh./human=inhalation absorption rate in humans
- AF for dose response relationship:
- 1
- Justification:
- a true NOAEL is available
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data available
- AF for remaining uncertainties:
- 1
- Justification:
- the data provided covers the addressed tonnage band
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:
- 2.06 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 175
- Modified dose descriptor starting point:
- NOAEL
- DNEL value:
- 360 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- a true NOAEL is available
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- default value for mice
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data available
- AF for remaining uncertainties:
- 1
- Justification:
- the provided data covers the addressed tonnage band
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: LOEL (rat) = 11.25 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- EC3/NOAEL extrapolation
- AF for differences in duration of exposure:
- 1
- Justification:
- no time-dependence expected for local skin effects
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary for local effects
- AF for other interspecies differences:
- 1
- Justification:
- not necessary for local effects
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data available
- AF for remaining uncertainties:
- 1
- Justification:
- the data provided covers the tonnage band
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Sodium thioglycolate (NaTG) was chosen for long-term animal studies to act as an appropriate surrogate for thioglycolic acid and its salts. Correcting the NOAEL for molecular weight is regarded as not necessary, as it has only minor effects on this value and finally on the DNELs.
Inhalation, systemic effects, long-term exposure
In a 90-day oral toxicity study performed in rats with NaTG, a NOAEL of 20 mg/kg bw/day for systemic toxicity has been determined.
Step 1) Relevant dose descriptor | NOAELRat= 20 mg/kg bw/day |
Step 2) Modification of starting point Conversion into inhalatory NOAEC (in mg/m³) by using an 8-hour standard respiratory volume for the rat Correction for differences between oral and inhalation absorption Correction for differences in 8-hour inhalative volumes between workers in rest and workers under light activity |
0.38 m³ /kg bw
1
6.7 m³ / 10 m³ |
Step 3) Assessment factors Interspecies Intraspecies Exposure duration Dose response Quality of database |
2.5 5 2 1 1 |
DNEL Value | 1.41 mg/m³ (20 x 1/0.38 x 1 x 6.7/10 x 1/(2.5 x 7 x 5 x 2 x 1 x 1)) |
Dermal, systemic effects
No difference between oral and inhalation absorption is assumed.
The available data suggests no relevant differences in dermal absorption among the salts of the thioglycolic acid.
In 90-day studies performed in rats and mice with NaTG, the dermal NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/day, respectively. The NOAEL > 360 mg/kg bw/day determined in mice is selected as a relevant dose-descriptor.
Step 1) Relevant dose descriptor | NOAELMouse> 360 mg/kg bw/day |
Step 2) Modification of starting point Correction for substance differences in dermal absorption |
1 |
Step 3) Assessment factors Interspecies Intraspecies Exposure duration Dose response Quality of database |
2.5 x 7 5 2 1 1 |
DNEL Value | > 2.06 mg/kg bw/day (360 x 1/(2.5 x 7 x 5 x 2 x 1 x 1)) |
Dermal, local effects
In a 90-day dermal toxicity study perfomed in rats with NaTG, the LOEL for local effects at the site of application (skin irritation) was 11.25 mg/kg bw.
Step 1) Relevant dose descriptor | LOELRat= 11.25 mg/kg bw/day |
Step 2) Modification of starting point Modification to LOEL for dermal irritation (in mg/cm²/day) |
0.25 kg / 44.5 cm² |
Step 3) Assessment factors Interspecies (local effects) Intraspecies Exposure duration Dose response (LOEL/NAEL extrapolation) Quality of database |
1 5 1 3 1 |
DNEL Value | 0.004 mg/cm²/day (11.25 x 0.25/44.5 x 1/(1 x 5 x 1 x 3 x 1)) |
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:
- 0.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- DNEL value:
- 180 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 dose response relationship:
- 1
- Justification:
- no time-dependence expected for local skin irritation
- 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
- Justification:
- ECHA default factor
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- good quality data available
- AF for remaining uncertainties:
- 1
- Justification:
- the provided data covers the addressed tonnage band
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
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNELs for the general population have not been proposed because thioglycolates are generally used as an ingredient in cosmetic products. According to Article 14, paragraph 5(b) of Regulation No. (EC) 1907/2006 (REACh), the chemical safety report does not need to include considerations of the risk to human health from end uses in cosmetic products within the scope of Regulation (EC) No. 1223/2009 (Cosmetics Regulation).
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.
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