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EC number: 407-000-3 | CAS number: 127519-17-9 CGL 384; TINUVIN 384
- 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
Oral: LD50 > 2000 mg/kg (male/female), OECD Guideline Study, Ciba-Geigy, 1990
Dermal: LD50 > 2000 mg/kg (male/female), OECD Guideline Study, Ciba-Geigy, 1990
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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Remarks:
- Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 172 to 215 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days, weighing: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in this study.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 4 days.
- Gross pathology:
- At autopsy, a small testis was found in one male. No deviations from normal morphology were found in the remaining animals.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 value of the test article in rats was found to exceed 2000 mg/kg body weight.
- Executive summary:
In a GLP-compliant oral toxicity study according to OECD guideline 401, five male and five female Tif:RAI rats were dosed once with the test article in arachis oil by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortalities were recorded. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests.
The animals recovered within 4 days. At autopsy, a small testis was found in one male. The body weight gain shown by the animals over the study period was considered to be normal. The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From Oct. 19, 1987 to Jan. 22, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP. A default reliability of 2 is assigned because of use as read-across
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain as stated in the report: Tif:RAI f (SPF) hybrids of RII/1 x RII/2
- Source: CIBA-Geigy Ltd. Animal Production, 4332 Stein Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 195 to 234 g
- Housing: group housed (5 per cage) in Macrolon cages, type 4
- Diet ad libitum: rat chow (NAFAG 890 tox)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The exposure apparatus was a nose-only exposure system developed by Battelle Research Centres (Geneve/Switzerland). The internal chamber volume was less than 1 l. The flow in any individual aerosol delivery tube was 2 l/min (velocity 1.25 m/sec) and the total flow was 32 l/min. The aerosol was generated using 2 pneumatic nebulizers in parallel.
- Method of holding animals in test chamber:
The rats were placed in macrolon animal holders during exposure.
- Treatment of exhaust air:
The exhaust air was decontaminated by passage through a Pall HDC absolute filter.
TEST ATMOSPHERE
The aerosol concentration in the chamber was determined gravimetrically 5 times during the exposure period. In the same time interval temperature, relative humidity and oxygen content of the inhalation chamber were assessed. The particle size was analyzed with an aerodynamic particle sizer, equipped with appropriate dilution systems to avoid coincidence counts.
VEHICLE
The test article was too viscous to be directly aerosolized. Preliminary experiments showed that a dilution with absolute ethanol (End concentration 30%) was suitable to generate an appropriate concentration in the inhalation atmosphere.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- determined gravimetrically 5 times during exposure period
- Duration of exposure:
- 4 h
- Concentrations:
- nominal; 11672 mg/m3
measured; 5838 +/- 151 mg/m3 - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- yes
- Details on study design:
- The control animals were treated with 61.8 g/h absolute ethanol (nominal concentration of 32.2 g/m3).
During exposure the animals were examined for clinical symptoms and mortalities at 1, 2, and 4 h, as well as 2 h after the exposure and daily thereafter for 14 days. Body weights were recorded immediately prior to exposure and on days 7 and 14 of the observation period. Gross pathological examinations were performed on all animals at day 14. - Statistics:
- Inhalation LC50 values and their 95% confidence limits were not calculated because there were no mortalities. The body weights of the treated animals and the controls were compared by analysis of variance.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.8 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: None of the animals died.
- Mortality:
- None of the animals died.
- Clinical signs:
- other: Ruffled fur, dyspnea, hunched posture and reduced spontaneous activity were seen in animals exposed to test material. They recovered within 6 days.
- Body weight:
- Males exposed to the test article showed a statistically significant higher body weight gain compared to controls during the first week after exposure.
- Gross pathology:
- No treatment related macroscopic findings were observed.
- Other findings:
- None
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Table 1: Mean body weights in gram (Dose level: 5.8 mg/l)
Test day |
0 |
7 |
14 |
|
|
|
|
Control males |
223 +/- 8 |
258 +/- 9 |
301 +/- 10 |
Treated males |
232 +/- 2 |
273 +/- 4 * |
314 +/- 9 |
|
|
|
|
Control females |
206 +/- 7 |
218 +/- 10 |
236 +/- 16 |
Treated females |
208 +/- 9 |
222 +/- 18 |
239 +/- 22 |
Body weights on day 0 were assessed before application of test article.
* p<0.05 versus control
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5.8 mg/m³ air
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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Remarks:
- Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: (Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 206 to 256 g
- Fasting period before study: no
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: about 10%
- Type of wrap if used: gauze-lined semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in this study.
- Clinical signs:
- other: Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute dermal tests. The animals recovered within 5 days.
- Gross pathology:
- At autopsy, no deviations from normal morphology were found.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The dermal LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The acute dermal toxicity of the test substance was assessed in a toxicity study following OECD guideline 402 and in compliance with GLP. The test article was administered to five Tif: RAI f rats of each sex by dermal application at 2000 mg/kg body weight. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute dermal tests. The animals recovered within 5 days. Body weight gain was normal throughout the study period. At autopsy, no deviations from normal morphology were found. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Oral: In a GLP-compliant acute oral toxicity study (OECD 401, Ciba-Geigy, 904252), two groups of fasted 6-8 week old rats (5/sex) were given a single oral dose of the test item in arachis oil at 2000 mg/kg body weight and observed for 14 days. No mortality occurred and body weight gain was found to be normal. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 4 days. At autopsy, a small testis was found in one male. No deviations from normal morphology were found in the remaining animals. Oral LD50 of male and female is greater than 2000 mg/kg bw. The test substance is of low toxicity based on the LD50 in males and females.
Dermal: In a GLP-compliant acute dermal toxicity study (OECD 402, Ciba-Geigy, 904255), two groups of 7 - 8 week old rats (5/sex) were dermally exposed to undiluted test material for 24 hours to 10% of body surface area at 2000 mg/kg body weight followed by an observation period of 14 days. No mortality occurred and normal body weight gain were found in this study. Piloerection, abnormal body positions and dyspnea were seen, being common symptoms in acute dermal tests. The animals recovered within 5 days. At autopsy, no deviations from normal morphology were found. Dermal LD 50 of male and female is greater than 2000 mg/kg body weight. The test substance is of low toxicity based on the LD50 of males and females.
Inhalation: The structurally related ester (EC 400 -830 -7) caused no mortality in an acute inhalation study (OECD 403, GLP) with aerosol.
Justification for selection of acute toxicity – oral endpoint
GLP-compliant guideline study
Justification for selection of acute toxicity – dermal endpoint
GLP-compliant guideline study
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC): The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral, inhalation or dermal toxicity under Directive 67/548/EEC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008: 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 acute oral, inhalation or dermal toxicity under Regulation (EC) No. 1272/2008.
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