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EC number: 800-149-9 | CAS number: 1410795-90-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 13-week study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study, according to and exceeding the requirements of the OECD TG 413 with additional emphasis on some of the male and female reproductive parameters. Tested with the source substance formic acid (CAS No. 64-18-6). For details on read-across refer to the attached read-across report.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 413
- Deviations:
- yes
- Remarks:
- emphasis on some of the male and female reproductive parameters including sperm morphology and vaginal cytology
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Formic acid
- EC Number:
- 200-579-1
- EC Name:
- Formic acid
- Cas Number:
- 64-18-6
- IUPAC Name:
- formic acid
- Test material form:
- not specified
- Details on test material:
- 95 % formic acid / 5 % water
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: 13 weeks
- Frequency of treatment:
- 5 days/week, 6 h/day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0; 8; 16; 32; 64; 128 ppm (as vapour)
Basis:
- Remarks:
- Doses / Concentrations:
0; 0.015; 0.031; 0.120; 0.241 mg/m3
Basis:
- No. of animals per sex per dose:
- 10/sex/group
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes - Oestrous cyclicity (parental animals):
- oestrus cyclicity analysed in rats of the 0, 8, 32, 128 ppm groups
- Sperm parameters (parental animals):
- sperm motility and concentration were analysed in rats of the 0, 8, 32, 128 ppm groups
- Postmortem examinations (offspring):
- At sacrifice, among other organs, the right testis was weighed
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not examined
Details on results (P0)
were slightly increased as compared to the control rats
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS): no effects observed
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS): no effects were observed on testicular weight, epididymal weight, sperm motility and epididymal and testicular sperm concentration
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.244 mg/L air
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Result: no effects on sperm motility, density, and testes and epididymal weight, or estrous cycle length
RS-Freetext:
Male and female reproductive organs:
Regarding the male and female reproductive organs, there
were no effects on sperm motility, density or testicular or
epididymal weights, and no changes were seen in the length
of the estrous cycle at any dose.
===========================================================
Parameter Exposure concentration (ppm)
0 8 32 128
-----------------------------------------------------------
Males
Weight (g)
right testis 1.40 1.45 1.47 1.41
left epididymis 0.449 0.461 0.469 0.460
left epididymal 0.167 0.171 0.174 0.169
tail
Spermatozoal measurements
Motility (%) 91+/-1 91+/-1 91+/-1 88+/-1
Concentration 658+/-21 706+/-21 580+/-60 651+/-29
(10E06/g)
Females
Estrous cycle 4.80 4.75 4.95 4.95
length (d)
===========================================================
The NOAEC was therefore 0.244 mg/l for systemic toxicity and
effects ob reproductive organs, and 0.122 mg/l for local
irritation in the respiratory tract.
Applicant's summary and conclusion
- Conclusions:
- Formic acid does not have adverse effects on F344 male and female rats when exposed via inhalation to concentrations up to 128 ppm.
- Executive summary:
In a reproduction study, formic acid was administered to 10 F344 rats/sex/dose via inhalation at dose levels of 0, 8, 16, 32, 64, and 128 ppm (0, 15, 30, 120, or 240 mg/kg bw/day).
No effects were observed on oestrus cyclicity, testicular weight, epididymal weight, sperm motility and epididymal and testicular sperm concentration. Body weight gains of the male rats of the 8, 16, 32 and 64 ppm groups were slightly increased as compared to the control rats. The NOAEL is 0.244 mg/L air in males and females.
This study is acceptable and satisfies the guideline requirement for a 90-daysubchronic inhalation toxicity test to examine reproductive endpoints; OECD 413, in rodents.
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