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EC number: 200-157-7 | CAS number: 52-89-1
- 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:
- supporting study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see justification
- Justification for type of information:
- Well documented. Short comings are: small animal number, no definite data on
actual intake of L-Cysteine hydrochloride monohydrate, no purity and no impurities given for the test substance and in results only means given; no min/max no standard deviation given (thus, results are not presented in very detail).
It is important to mention that the substance was applied within the bread baking procedure and heated up to 227°C for 1/2 hour. This may have influenced the stability of the test substance especially as there are comments declaring a decomposition temperature of 175-177.8 °C for L-Cysteine hydrochloride. Nevertheless the documentation is complete enough, so that the influence of the baking process could be evaluated by an additional test if needed.
All in all the study can be jugded as a screening test for the evaluation of the deveolppmental toxicity.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- before 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see justification
- Justification for type of information:
- Well documented study. Short comings are: small animal number, no definite data on actual intake of L-Cysteine hydrochloride monohydrate, no purity and no impurities given for the test substance.
In results: only means given; no min/max no standard deviation given (thus, results are not presented in very detail).
It is important to mention that the substance was applied within the bread baking procedure and
heated up to 227°C for 1/2 hour. This may have influenced the stability of the test substance especially as there are comments declaring a decomposition temperature of 175-177.8 °C for L-Cysteine hydrochloride. Nevertheless the documentation is complete enough, so that the influence of the baking process could be evaluated by an additional test if needed.
Therefore the study can be jugded as a valid screening test for the evaluation of toxic effects on fertility - Principles of method if other than guideline:
- L-Cysteine hydrochloride monohydrate was added to flour at levels of 0, 35, 350 and 3500 ppm.
Bread was baked from this flour, dried and milled to a powder, which was added to the rats diet.
Starting with 4 pregnant rats in the control and the highest dosage group the mothers and all pups were slaughtered except for 2 male and 3 female pups selected at random from each litter, which were retained for breeding.
This procedure was continued in the second and third generations, but at the weaning of the fourth generation only 24 males and 48 females were retained for breeding, i.e. 12 males and 24 females on each diet. The same procedure as before was adopted for the sixth generation, using all four dosages, and during the breeding of the seventh generation the experiment was terminated. - GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: C.D. Norwegian Hooded of an inbred Middle Aston strain
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Starting with pregnant C.D. Norwegian Hooded rats of an inbred Middle Aston strain.
- Route of administration:
- oral: feed
- Details on exposure:
- The substance was added to flour in concentrations of 0, 35, 350 and 3500 ppm. With this flour bread was baked. After the baking the bred was sliced, freeze-dried, crushed and milled. This powder was mixed to a diet. The diets contained about 77% of bread crumbs on dry weight
No feed intake is reported. An animal weight of 100 g and a feed intake of 10 g diet per animal and day is used for estimation of the doses. 77% of milled bread was added to the diet. This resulted in an estimated daily intake of L-Cysteine of 0, 2.7, 27 and 270 mg/kg bw.. - Details on mating procedure:
- For the first generation pregnant rats were used. No data on mating procedure available. 11 weeks after birth the next generation females were mated with males from the same litter. During the breeding of the seventh generation the experiment was terminated.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 generations
- Frequency of treatment:
- daily
- Details on study schedule:
- L-Cysteine hydrochloride monohydrate was added to flour in concentrations of 0, 35, 350 and 3500 ppm. With this flour bread was baked. After the baking a powder was produced and mixed to a diet.
The test article intake is estimated: An animal weight of 100 g and a daily feed intake of 10 g diet per animal and day is presumed. 77% of milled bread was added to this diet. This resulted in an estimated daily intake of L-Cysteine hydrochoride monohydrate of 0, 2.7, 27 and 270 mg/kg bw..
For the first generation pregnant rats were used. Starting with 4 pregnant rats in the control and the highest dosage group the mothers and all pups were slaughtered after weaning except for 2 male and 3 female pups selected at random from each litter, which were retained for breeding.
11 weeks after birth the next generation females were mated with males from the same litter.
This procedure was continued in the second and third generations, but at the weaning of the fourth generation only 24 males and 48 females were retained for breeding, i.e. 12 males and 24 females on each diet. The same prodceure as before was adopted for the sixth generation, using all 4 dosages, and during the breeding of the seventh generation the experiment was terminated. - Dose / conc.:
- 3 500 ppm
- Remarks:
- flour weight
- Dose / conc.:
- 350 ppm
- Remarks:
- flour weight
- Dose / conc.:
- 35 ppm
- Remarks:
- flour weight
- Dose / conc.:
- 0 ppm
- Remarks:
- flour weight
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- Estimation of the actual intake of L-Cysteine hydrochloride monohydrate:
feed intake: animal weight: 100g, 10 g diet per animal and day. 77% of milled bread was added to the
diet. This resulted in an estimated daily intake of L-Cysteine of 0, 0.27, 2.7 and 27 mg per animal. - Positive control:
- no
- Parental animals: Observations and examinations:
- examinations for gross lesions
- Postmortem examinations (offspring):
- examinations for gross lesions
- Reproductive indices:
- Number born, litter weight at birth, numbers weaned and litter weight at weaning, carcass, liver and kidney weights of all slaughtered aninmals, post mortem examination for gross lesions.
In the 0 and 3500 ppm groups the principal characteristics of the response to the treatment were
measured: rate of change per generation in litter size and weight at birth and at weaning, and the rate of change in the size of the carcasses, livers and kidneys of both adults and weanling rats. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 270 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Critical effects observed:
- no
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 270 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Reproductive effects observed:
- not specified
- Conclusions:
- L-Cysteine hydrochloride monohydrate was added to flour. With this flour bread was baked and from this bread a powder was produced and mixed to the diet. A daily intake of 0, 2.7, 27 and 270 mg/kg bw. was estimated..
Starting with 4 pregnant rats in the control and the highest dosage group a study over 7 generations was conducted.
Although quite well documented the study has short comings as there are: small animal number, no definite data on actual intake of L-cysteine hydrochloride monohydrate, no purity and no impurities given for the test substance and in results: only means, no min/max no standard deviation are given.
Nevertheless the study can be jugded as a valid screening test for the evaluation of the reproduction toxicity.
Up to and including dosages of 270 mg/kg bw. no adverse effects on fertility occurred in the rats
during the experiment even at the high level of L-cysteine hydrochloride monohydrate treatment. - Executive summary:
L-Cysteine hydrochloride monohydrate was added to flour in concentrations of 0, 35, 350 and 3500 ppm. With this flour bread was baked. After the baking the bred was sliced, freeze-dried, crushed and milled. This powder was mixed to a diet. The diets contained about 77% of bread crumbs on dry weight.
Estimation of doses: An animal weight of 100 g and a daily feed intake of 10 g diet per animal and day is estimated. 77% of milled bread was added to this diet. This resulted in an estimated daily intake of L-cysteine hydrochloride monohydrate of 0, 2.7, 27 and 270 mg/kg bw..
For the first generation pregnant rats were used.
Starting with 4 pregnant rats in the control and the highest dosage group the mothers and all pups were slaughtered after weaning except for 2 male and 3 female pups selected at random from each litter, which were retained for breeding.
11 weeks after birth the next generation females were mated with males from the same litter.
This procedure was continued in the second and third generations, but at the weaning of the fourth generation 24 males and 48 females were retained for breeding, i.e. 12 males and 24 females on each diet. The same prodceure as before was adopted for the sixth generation, using all 4 dosages, and during the breeding of the seventh generation the experiment was terminated.
Recorded are number born, litter weight at birth, numbers weaned and litter weight at weaning, carcass, liver and kidney weights of all slaughtered aninmals, post mortem examination for gross lesions. In the 0 and 3500 ppm groups the principal characteristics of the response to the treatment were measured:
rate of change per generation in litter size and weight at birth and at weaning, and the rate of change in the size of the carcasses, livers and kidneys of both adults and weanling rats.
Breeding rats of the fifth generation at about 150 days of age and receiving the diet with the highest L-cysteine hydrochloride monohydrate treatment (3500 ppm) were examined histopathologically. They showed no lesions atypical in normal rats of that age.
No adverse effects on fertility occurred in the rats during the experiment even at the high level of Lcysteine hydrochloride monohydrate treatment.It is important to mention that the substance was applied within the bread baking procedure and heated
up to 227°C for 1/2 hour. This may have influenced the stability of the test substance especially as there
are comments declaring a decomposition temperature of 175-177.8 °C for l-cysteine hydrochloride.
Nevertheless the documentation is complete enough, so that the influence of the baking process could be evaluated by an additional test if needed.
As results only means given; no min/max no standard deviation given.
No treatment related effects were observed (authors: "no obvious adverse effect").
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- L-Cysteine hydrochloride monohydrate was added to flour from which bread was baked, milled to a powder. This powder was added to the diet.
A daily intake of 0, 2.7, 27 and 270 mg/kg bw. can be estimated.
Starting with 4 pregnant rats in the control and the highest dosage group the study was conduced
over 7 generations.
Especially the data on litter weight at weaning and the post mortem examination for gross lesions of both adults and weanling rats reveal and the histopathologic examination of the fifth generation can reveal devolopmental toxicity.
No developmental toxicity was observed.
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