Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 252-038-4 | CAS number: 34452-51-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.13 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 23 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 28.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.285 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 114 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 85.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Long-term exposure
Sodium thioglycolate (NaTG) was choosen 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 a negligible effect on this value.
Dermal, systemic effects
The available data suggests no relevant differences in dermal absorption among salts of thioglycolic acid.
In 90-day studies performed in rats and mice with sodium thioglycolate, the dermal NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/day, respectively. The NOAEL > 360 mg/kg bw/day 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)) |
Inhalation, systemic effects
In a 90-day oral toxicity study performed in rats with sodium thioglycolate, the NOAEL for systemic toxicity was 20 mg/kg bw/day.
No difference between oral and inhalation absorption is assumed.
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, local effects
In a 90-day dermal toxicity study perfomed in rats with sodium thioglycolate, 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 23 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
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:
- 33.9 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 114 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.115 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 23 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 23 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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 of Regulation (EC) No.1907/2006, 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 Directive 76/768/EEC.
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.
