Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-540-9 | CAS number: 5421-46-5
- 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
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- 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
Endpoint summary
Administrative data
Description of key information
Ammonium thioglycolate 71% (ATG 71) is considered to be slightly irritating to the skin and the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Mar 2003 - 9 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.4 ± 0.1 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France) ad libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 71.5 % active substance - Duration of treatment / exposure:
- 3 min, 4 h
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 6). - Number of animals:
- 3
- Irritation parameter:
- erythema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: one animal
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: one animal
- Irritation parameter:
- erythema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item ammonium thioglycolate 71% is slightly irritating when applied topically to rabbits.
Classification: not irritating
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Mar 2003 - 16 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.7+/-0.2 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay sur Orge, France) ad libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 71.5% active substance - Duration of treatment / exposure:
- continuous
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item ammonium thioglycolate 71% is slightly irritant when administrated by ocular route to rabbits.
The criteria for classification as an eye irritant are not met.
Reference
(For details on results refer to attached background material)
Very slight to moderate conjunctival reactions, including a very slight or slight chemosis (grade 1 or 2), a very slight to moderate redness of the conjunctiva (grades 1 to 3) and a clear to whitish purulent discharge, were observed in all animals, from day 1 up to day 3. No other ocular reactions were noted during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.7 and 0.7 for chemosis, 0.7, 1.0 and 1.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of ammonium thioglycolate (71% solution) and sodium thioglycolate (98% pure) was evaluated in studies performed according to the OECD guideline 404 (Klein, 2003c and 2003d). Because irritant effects were anticipated, a single albino rabbit was tested first before the other two animals were used. The test material (0.5 ml or 0.5 g) was applied to the shaved, intact skin on one flank for 3 min and for 4 h on the other flank in the first animal. The sites were semi-occluded.
The test materials were non-irritating in the first animal, so it was applied to a single flank in the other two rabbits for 4 h (the other flank served as a control). The animals were examined for signs of erythema, eschar, and edema and skin reactions were measured 1, 24, 48, and 72 h after termination of exposure. Both substances induced a slight irritation.
The skin irritation potential of 71% ammonium thioglycolate was also evaluated in a former study performed according to the US EPA guideline 16 CFR 1500.41. 0.5 ml test material was applied to each of two sites, one on abraded skin, and the other site on intact skin of each of 6 rabbit. The test sites were then immediately occluded for a 24-hour exposure period. At the end of 24 hours, the plastic wrappings and patches were removed. The skin sites were then individually examined and scored separately for both erythema and edema using the Draize method. After 72 hours the sites were examined and rescored.
Three of the six rabbits died during the test. The mean erythema scores over 24 and 72 hours for each surviving animal were 3.0, 3.0 and 3.0 for both the intact and abraded skin. The edema scores were 2.5, 3.0 and 2.5 for the intact skin and 2.5, 2.5 and 2.5 for the abraded skin (Griffiths and Koschier, 1979b). Under the condition of a 24-hour occlusive exposure, 71% ammonium thioglycolate was severely irritating to the skin.
Skin irritation has also been reported in humans in the context of skin sensitisation tests. Refer to Section 7.10.
The eye irritation potential of ammonium thioglycolate (71% solution) and sodium thioglycolate (98% pure) has been investigated in rabbits in studies compliant with the OECD guidelines 405 (Klein, 2003e and 2003f). A volume of 0.1 ml of ammonium thioglycolate or 100 mg of sodium thioglycolate was instilled into the conjunctival sac of one eye of the 3 test animals. The eyes were not rinsed after administration of the test item. The other eyes served as controls. The eye irritation reactions were scored approximately 1 hour, 24, 48 and 72 hours (both salts) and up to 8 days (sodium salt only) after the instillation. Both compounds induced a slight irritation.
At the 72-hour scoring, all scores were 0.0 for the 3 rabbits treated with ammonium thioglycolate. With sodium thioglycolate, all scores were 0.0 at 72 hours for rabbits 1 and 2 and on day 8 for rabbit 3. Both compounds are considered as slightly irritating.
The eye irritation potential of ammonium thioglycolate (71% solution) has also been investigated in a study compliant with the US EPA guideline 16 CFR 1500.42 (Griffiths and Koschier, 1979c). A volume of 0.1 ml of ammonium thioglycolate was instilled into the conjunctival sac of one eye of the 6 test animals. The eyes were not rinsed after administration. The other eyes served as controls. The eye irritation reactions were scored approximately 1 hour, 24, 48 and 72 hours and 7 days after the instillation. Ammonium thioglycolate induce a mild irritation, mean enanthema (redness), chemosis, corneal opacity and iritis scores over 24, 48 and 72 hours were 2.6, 0.0, 0.0 and 0.0, respectively. On day 7 redness score was zero.
Justification for classification or non-classification
Justification for selection of skin
irritation / corrosion endpoint:
In contrast to Griffiths et al. the study conducted by Klein is a
GLP and guideline study.
Justification for selection of eye irritation endpoint:
In contrast to Griffiths et al. the study conducted by Klein is a
GLP and guideline study.
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.