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EC number: 700-934-5 | CAS number: -
- 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
The acute dermal and oral toxicity of EUF was above 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 05 to November 27 (experimental period)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld
- Age at study initiation: not detailed
- Weight at study initiation: 142-172g (on day of dosing)
- Fasting period before study: overnight
- Housing: In macrolon cages, 2 or 3 animals per cage
- Diet : ad libitum
- Water : e.g. ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark /12 hrs light):
IN-LIFE DATES (DOSING): Sighting study: November 6th, 2007; Main study: November 14, 2007 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 80%
- Justification for choice of vehicle: Soluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Fixed dose method, started with 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female used for sighting study
4 females used for main experiment - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight recording: day 0 (test start), day 7 day 14 ; Clinical signs: each rat was observed 30 min., 2, 4 and 6 hours post-dosing and daily thereafter over a period of 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No preterminal deaths. Therefore no statistical proceduresecessary
- Preliminary study:
- 1 female was dosed at 2000 mg/kg bw.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no preterminal deaths. Therefore no CL determined
- Mortality:
- No animal died
- Clinical signs:
- other: Hunched posture and piloerection were observed from 30 min. p.a. onwards up to 6 hours. From Day 1 to the end of the observation period, the animals were free of any abnormalities.
- Gross pathology:
- No specific findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of the study indicate that the acute oral toxicity in female animals was above 2000 mg/kg body weight.
- Executive summary:
Study was performed according to OECD guideline 420 (fixed dose procedure). One dose level of 2000 mg/kg bw (limit test). was used and applied orally as single administration to 4 females rats.
All survivors were subjected to a 14 days post-treatment observation period. All rats were observed for clinical signs, body weight development. Macroscopic findings were recorded in all animals.No animal died. Clinical signs observed at the 2000 mg/kg dose level were piloerection and hunched posture p to 6 hours post dosing. Body weight development was within normal ranges. No macroscopic organ findings were observed at necropsy.
Reference
Table for Acute Oral Toxicity of TPI 1618 |
|||
Dose [mg/kg bw] |
Number of dead / |
Time of death (range) |
Observations |
2000 |
females 0/4 |
n.a. |
Clinical signs:
|
LD50value (females) |
> 2000 mg/kg bw |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 28, 2004 to July 21, 2004 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DIMED Schönwalde
- Weight at study initiation: 210 – 261 g
- Fasting period before study: Overnight prior to dosing
- Housing: Macrolon Type III cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-3
- Humidity (%): 55 +- 15
- Air changes (per hr): 10
- Photoperiod 12 hrs dark /12 hrs light
IN-LIFE DATES: From June 22, 204 to July 21, 2004 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6x8 cm
- Type of wrap if used: 4-layer gauze packs fixed with Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours post dosing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): used undilutedly - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations 1, 3 and 6 hours after the start of dosing and daily thereafter over 14 days; body weights recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- No preterminal deaths; therefore no statistical procedures empoyed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities
- Clinical signs:
- other: Males and females showed piloerection 1, 3 and 6 hours p.a. as well as on day 1. The skin and adjacent areas were yellowish discoloured caused by the test item.
- Gross pathology:
- External examination of animals at termination of the study did not reveal any lesions of pathological significance.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of Formaldehyddepot EFU (TPI 1618) is low with an LD50 greater than 2000 mg/kg bw.
- Executive summary:
The study was performed according to OECD guideline 402 and designed as a limit-test using a single dose of 2000 mg/kg bw in rats. No pre-terminal deaths were observed in any of the rats after dermal application of 2000 mg/kg bw. Clinical signs were limited to piloerection up to and including Day 1 of dosing. Yellowish staining of the skin was induced by the test item.
The LD50for male and female rats after dermal exposure was greater than 2000 mg/kg bw. Thus no classification is required.
Reference
Table for acute dermal toxicity: clinical signs and pathology |
|||
Dose (mg/kg bw.) |
Number of dead / |
Time of death (range) |
Observations |
2000 mg/kg |
males 0/5, |
n.a. |
Clinical signs: Piloerection up to and including Day 1 p.a. in all animals Pathology |
LD50value |
>2000 mg/kg bw. |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Acute oral and dermal toxicity was investigated in studies according to current guidelines. The acute oral toxicity of EUF was above 2000 mg/kg bw in a limit test. Clinical signs observed in rats after oral application were hunched posture and piloerection. Pathology revealed no treatment-related effects.
An acute inhalation toxicity study with EUF has not been performed.
Though the existing and most recently performed acute dermal irritation study with EUF did not indicate EUF to be an irritant compound, however, irritation can nevertheless be expected if the test item is allowed to hydrolyse. The maximum releasable formaldehyde portion of 49% from EUF is expected to cause burns. Therefore, testing inhalation route is not regarded as scientifcally justified.
Justification for classification or non-classification
Acute oral toxicity
Based on the most recent data with LD50 values of > 2000 mg/kg bw, there is no need for a classification according to the CLP regulations of EC Directive 1272/2008 and GHS.
Acute inhalation toxicity
Classification not possible. No study performed.
Acute dermal toxicity
Based on the data with an acute dermal toxicity of >2000 mg/kg bw, there is no need for a classification according to the CLP regulations of EC Directive 1272/2008 and GHS.
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