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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium mercaptoacetate
- EC Number:
- 226-540-9
- EC Name:
- Ammonium mercaptoacetate
- Cas Number:
- 5421-46-5
- Molecular formula:
- C2H4O2S.H3N
- IUPAC Name:
- ammonium 2-sulfanylacetate
- Details on test material:
- Test substance: Ammonium thioglycolate (71%)
Source: Merck KGaA
Batch: U1499277
Content of active ingredient: 71.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Strain of rats: Hsd/Cpb: WU
Source: Fa. Harlan Winkelmann GmbH, 33178 Borchert
Age: 9-10 weeks old
Acclimatization period: 6 days
Weight range at study initiation: 177-213 g Diet: Altromin Standard Diet TPF N 1234, ad libitum
Water: Tap water, ad libitum
Husbandry:
Housing: Makrolon type III cages
Illumination: artificial lighting from 6.00 a.m. - 6.00 p.m.
Temperature: 21-23.5°C
Relative humidity: 51-66%Vehicle: demineralized water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- - Rate of solution preparation: daily
- Amount of vehicle: 10 ml/kg (base on weight on GD6) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration and homogeneity of ammonium thioglycolate in preparations administred were determined once during the study, on the second day of treatment. The results showed values ranging from 96.5 % to 100 % of the nominal concentrations
- Details on mating procedure:
- - Groups of four sexually matures, virgin females were left over night with one stock stud.
- Proof of pregnancy: sperm in vaginal smear (GD 0) - Duration of treatment / exposure:
- gestation days 6 - 19
- Frequency of treatment:
- daily
- Duration of test:
- Duration of test: 15 days - dosing GD 6 -19, animals were killed on day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3 mg/kg bw/day
- Dose / conc.:
- 15 mg/kg bw/day
- Dose / conc.:
- 75 mg/kg bw/day
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Clinical signs including mortality and evidence of abortion were checked daily.
Body weight was determined on GD0, 6 and daily until GD20.
Food and water consumption were recorded at designated intervals during pregnancy.
On day 20 of pregnancy, females were killed. The terminal body weights of the dams were recorded. Females were examined macroscopically.
Litter parameters were recorded: number of corpora lutea, implantation sites, early and late resorptions, and dead and live foetuses. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes: - Fetal examinations:
- Foetuses were weighed, sexed, and submittedto external examination. About 1/2 of them were examined for skeletal malformations and 1/2 for organ malformations.The foetus sex was determined on the base of measurment of anogenital indice and by inspection of gonads.
- Statistics:
- yes: Dunnett test or Fischer-Pitman permutation test
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- see below
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- see below
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Details on results:
- Rooting in the bedding material was seen in all rats in the high dose group. Two animals in the high dose group died on GD 20, one day after the last administration of the test material. These deaths are regarded to be treatment related.
18 to 24 rats out of 25 per group proved to be pregnant.
The body weight development, food and water consumption were not affected by treatment. The terminal body weights were similar in all groups.
The uterus weights in the high dose group were slightly, but not significantly lower than in the control or the other groups. This finding is regarded to be accidental. The numbers of corpora lutea, implantations and live foetuses were not affected.
The numbers of dead foetuses, complete, early and late resorptions were not increased. The sex distribution was not affected in any of the groups.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- mortality
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 75 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- mortality
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- The weights of the foetuses in the low, mid, and high dose groups were similar to the control and not affected by treatment. The frequency of all malformations was in a normal range and not increased.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 75 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 75 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The doses of 3 and 15 mg ammonium thioglycolate/kg were systemically tolerated by the rats.
At dose level of 75 mg/kg, two dams died on GD 20. Rooting in the bedding material had been seen, but no maternotoxic effects.
The no observed effect level (NOEL) for embryo-fetal toxicity was 75 mg/kg.
No teratogenic effects were observed. - Executive summary:
The potential of ammonium mercaptoacetate to induce developmental toxicity after maternal exposure during the critical period of organogenesis was evaluated in rat according to OECD Guideline N° 414 (22nd January 2001) and in compliance with Good Laboratory Practices.
Ammonium mercaptoacetate was administered orally by gavage to four groups of 25 bred female Sprague-Dawley rats once daily from gestation days 6 through 19. Dosage levels were 0, 3, 15, and 75 mg/kg/d.
The fetuses were delivered by caesarean section on GD 20 and examined for macroscopic malformations. About 1/2 of them were examined for skeletal malformations and 1/2 for organ malformations. Clinical signs including mortality and evidence of abortion were checked daily. Body weight was determined on GD0, 6 and the daily until GD20. Food and water consumption was recorded at designated intervals during pregnancy. On day 20 of pregnancy, females were killed. The terminal body weights of the dams were recorded. The gravid uterus was weighed and foetuses removed by hysterectormy. Females were examined macroscopically.
The doses of 3 and 15 mg ammonium thioglycolate/kg were systemically tolerated by the rats. All animals in the low and medium level dose group survived to the scheduled necropsy. At the dose level of 75 mg/kg, two dams died on GD20, one day after the last administration of test material. These death were considered treatment related. At this dose level, rooting in the bedding material had been seen in all rats, but no maternotoxic effects. No treatment related internal findings were observed at any dose level. No clinical signs that could be attributed to ammonium mercaptoacetate were observed in the treated groups. Body weight and food consumption were not affected by treatment. Intrauterine growth and survival were unaffected by ammonium mercaptoacetate administration at all dose levels. Any significant or relevant foetal external, soft tissue and skeletal malformations were observed at any dose level. The developmental variations expressed in the treated groups were generally similar to those present in the control group or occurred in a manner that was not dose related. No teratogenic effects were observed
Under these experimental conditions, the No-Observed-Adverse-Effect-Level (NOAEL) was 15 mg/kg/d for maternal toxicity. A NOAEL has been determined at 75 mg/kg/d for embryo-foetal toxicity.
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