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EC number: 201-126-0 | CAS number: 78-59-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There is no evidence indicating that the test substance interferes adversely with the reproduction. No changes were observed in pregnancy rates, litter sizes, pup abnormalities or in histopathological examinations of the reproductive organs after long-term studies.
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Limitations: only one dose tested, small group size
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a limited one generation study, rats were exposed to the test substance in air. After three months of exposure, exposed males were mated with control and exposed females, control males were mated with control and exposed females. Exposure of females continued throughout gestation and they were allowed to deliver.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 140 g - Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- air
- Details on mating procedure:
- after three months of exposure overnight mating of
5 exposed males with 5 exposed females
5 exposed males with 5 control females
5 control males with 5 exposed females
5 control males with 5 control females
next morning exposure continued for exposed animals (females until littering)
No information on mating success. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: 6 hours/day
Premating exposure period (males): 3 months
Premating exposure period (females): 3 months
Duration of test: females: 4 months; males: 6 months - Frequency of treatment:
- 5 days/week
- Dose / conc.:
- 500 ppm
- Remarks:
- = 2873 mg/m3 (saturation)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Parental animals: Observations and examinations:
- behaviour, body weight development, mortality
- Litter observations:
- number and vitality
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Irritation of eyes and nose (in exposed animals)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortalities in control groups.
1/10 of exposed females and 2/10 of exposed males died. - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- 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
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Slight to medium congestion in lungs with similar intensity in exposed and control; granular state and clarification of liver cytoplasma with similar intensity in exposed and control.
- Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Dose descriptor:
- LOAEC
- Remarks:
- general toxicity
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Remarks on result:
- other: corresponds to 2873 mg/m³
- Dose descriptor:
- NOAEC
- Remarks:
- fertility
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Remarks on result:
- other: corresponds to 2873 mg/m³
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Developmental immunotoxicity:
- not examined
- Dose descriptor:
- NOAEC
- Remarks:
- = 2873 mg/m³
- Generation:
- F1
- Effect level:
- 500 ppm
- Remarks on result:
- other: no adverse effects observed
- Critical effects observed:
- no
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2 873 mg/m³
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 30
- Species:
- rat
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a limited one generation study, 10 male and 10 female Wistar rats were exposed to 2872 mg/m3 (500 ppm) test substance in air (Dutertre-Catella, 1976). After three months of exposure, 5 exposed males each were mated with 5 control and 5 exposed females, 5 control males each were mated with 5 control and 5 exposed females. Exposure of females continued throughout gestation and they were allowed to deliver. Treatment with the test substance did not influence pregnancy rates and litter sizes nor were there any abnormalities observed in the pups.
The histological examinations of the reproductive organs of male and female mice and rats (mammary gland, seminal vesicle, prostate/testis or ovary/uterus) treated orally with up to 1000 mg test substance/kg bw for 13 weeks did not reveal any adverse effects after macroscopic and microscopic examination (Bucher, 1986). In a 90-day study with male and female beagle dogs (4 animals/dose/sex were administered up to 150 mg test substance per kg bw per day) no changes were reported either after histopathological examination of testes, prostate, seminal vesicles or ovary, uterus, mammary gland, respectively (Rohm & Haas, 1972).
Effects on developmental toxicity
Description of key information
In an inhalation teratogenicity study, the NOAEL for maternal toxicity
was 289 mg/m³ (based on a reduction in body weight gain and food
consumption).
The test substance was neither embryotoxic nor teratogenic up to the
highest test concentration of 664 mg/m³.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Vehicle: no vehicle.
Concentrations: 0, 25, 50, 115 ppm (corresponds to 0.144, 0.289, 0.664 mg/L; low mid and high dose).
Type or preparation of particles: vapor.
Pregnant rats were dosed on days 6 through 15 of gestation (G). - Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- Length of cohabitation: until confirmed to have mated
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- gestation day 6 - gestation day 15
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- Section on gestation day 20
- Dose / conc.:
- 25 ppm
- Remarks:
- corresponds to 0.144 mg/L
- Dose / conc.:
- 50 ppm
- Remarks:
- corresponds to 0.289 mg/L
- Dose / conc.:
- 115 ppm
- Remarks:
- corresponds to 0.664 mg/L
- No. of animals per sex per dose:
- 22 mated female rats per dose level
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: based on results of preliminary study
- Maternal examinations:
- PARAMETERS ASSESSED DURING STUDY
Body weight gain: each 3rd day.
Food consumption: 3 day intervals.
Clinical observations: each 3rd day. - Ovaries and uterine content:
- PARAMETERS ASSESSED DURING STUDY
Examination of uterine content: identified as live fetuses, dead fetuses, late resorptions, and early resorptions at the end of the study (day 20 of gestation). The uterus of each animal was stained in 10 % aqueous ammonium sulfide and further examined for confirmation of implantation sites. Corpora lutea were counted. - Fetal examinations:
- PARAMETERS ASSESSED DURING STUDY
Examination of fetuses: Live and dead fetuses were weighed, examined externally for gross abnormalities, and crown-rump distances were determined.
Further examinations: skeletal malformations and ossification variations. - Statistics:
- Bartlett's test of homogeneity of variance: body weight, body weight change, food consumption, number of implantation sites, ratio of live fetuses to implantation sites, ratios of resorptions to implant sites, malformations per litter. Kruskal-Wallis test if variances were not equivalent. Standard nested analysis of variance for fetal weights.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- dose related increases in alopecia and staining of the cervical and anogenital areas
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced on gestation days 12 (-6.1 %) and 15 (-6.8 %) in high dose group
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- reduced food consumption in high dose group (days 6-20 and 0-20)
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- 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:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not examined
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- No statistically significant differences between treated and control groups: Number of resorptions, number of implantations, number of corpora lutea, duration of pregnancy.
- Dose descriptor:
- NOAEC
- Effect level:
- 0.289 mg/L air
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- not examined
- 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
- Details on embryotoxic / teratogenic effects:
- No statistically significant differences between treated and control groups:
Litter size and weights, number viable, sex ratio, grossly visible abnormalities, external abnormalities, soft tissue abnormalities, skeletal abnormalities.
During the conduct of the study there was one instance of exencephaly noted in a rat fetus. Based on the observations made in this study the authors do not believe that this anomaly was related to the test material. - Dose descriptor:
- NOAEC
- Effect level:
- 0.664 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to and including the highest tested concentration
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- The test material elicited a clinical effect in the pregnant dams in the form of decreased food consumption, lower body weights and dose related increases in alopecia and staining of the cervical and anogenital areas.
Within the framework of the dose levels and test methods used, the test material was not teratogenic or fetotoxic.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 289 mg/m³
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Pregnant Fischer 344 rats and CD-1 mice were exposed on days 6 through 15 of gestation to test substance concentrations of 144, 289, or 664 mg/m³ (22 animals per dose level). There was a significant reduction in food consumption in rats and mice of the highest dose group. Body weight was reduced in rats (gestation day 12: -6.1%; gestation day 15: -6.8%) and mice (gestation day 18, corrected for uterine weight: -5.6%) of the highest dose group. In rats, a dose related increase in alopecia was observed, as well as a discoloration of the cervical and anogenital region. In mice, this effect was observed only in one animal of the high dose group. Adverse effects on the fetuses were not observed (Exxon, 1984).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008, as amended for the 14th time in Regulation (EU) 2020/217.
Additional information
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.