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EC number: 455-790-3 | 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
In an OECD Test Guideline 425 study, to GLP, the acute oral LD50 of Gasir 1 was found to be greater than 2000 mg/kg bw.
In an OECD Test Guideline 403 study, to GLP, the acute inhalation LC50 of Gasir 1 was found to be greater than 5.04 mg/l.
In an OECD Test Guideline 402 study, to GLP, the acute dermal LD50 of Gasir 1 was found to be greater than 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
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 194-223g
- Fasting period before study:overnight before dosing
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%):30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light):12hrs dar/12hrs light - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:no data
- Amount of vehicle (if gavage):no data
- Justification for choice of vehicle:the test material did not dissolve/suspend in distilled water
MAXIMUM DOSE VOLUME APPLIED:
The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. - Doses:
- 175, 550, 2000
- No. of animals per sex per dose:
- 175mg/kg: 1
550mg/kg: 1
2000mg/kg: 3 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30min, 1, 2 and 4 hours after dosing and subsequently once daily for 14days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Body weight: prior to dosing and seven and fourteen days after treatment - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 550 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 175 mg/kg bw; Number of animals: 1; Number of deaths: 0 - Clinical signs:
- other: Hunched posture was noted in the animal treated at a dose level of 550mg/kg. Signs of systemic toxicity noted in two animals treated at a dose level of 2000mg/kg were hunched posture and pilo-erection. There were nog signs of systemic toxicity noted in th
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
See attached documents.
Reference
Individual bodyweights and weekly bodyweight changes
Dose level mg/kg | Animal number and sex | Bodyweight (g) at day | Bodyweight gain (g) during week | |||
0 | 7 | 14 | 1 | 2 | ||
175 | 1 -0 Female | 201 | 239 | 244 | 38 | 5 |
550 | 2 -0 Female | 194 | 209 | 224 | 15 | 15 |
2000 | 3 -0 Female | 197 | 239 | 249 | 42 | 10 |
2000 | 4 -0 Female | 223 | 255 | 260 | 32 | 5 |
2000 | 5 -0 Female | 203 | 246 | 272 | 43 | 26 |
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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- The quality of the test atmosphere fully complied with criteria documented in the respective guidelines: OECD 403, EPA OPPTS 870.1300 and Council Regulation (EC) No 440/2008.
- Deviations:
- yes
- Remarks:
- The temperature in the animal room was slightly increased (up to 0.7°C higher than the upper limit) on two days during the acclimation period. This deviation was considered to have no impact on the outcome of the study and interpretation of the results.
- GLP compliance:
- yes (incl. QA statement)
- 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:Charles River Laboratories, Research Model and Services, Germany GmbH (Sandhofer Weg 7, D-97633, Sulzfeld)
- Age at study initiation: 8-9 weeks old (sighting exposure), 9-10 weeks old (main study)
- Weight at study initiation: male: 344g, female: 214g (sighting exposure), male: 360-394g, female: 222-244g (main study)
- Housing: Group caging (5 animals, by sex, per cage), during the sighting study individual caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days (sighting study) or 8 days (main study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19.5-25.7°C
- Humidity (%):40-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:TSE Rodent Exposure System (TSE Systems GmbH, Bad Homburg, Germany).
- Exposure chamber volume: 3.85L
- Method of holding animals in test chamber: polycarbonate restraint tubes
- Source and rate of air: 0.5L/min
- Method of conditioning air:
- System of generating particulates/aerosols: Rotating brush dust generator Palas RBG 1000 (Palas GmbH, Karlsruhe, Germany)
- Method of particle size determination: From the animal breathing zone using a cascade impactor
- Treatment of exhaust air: through a suitable filter system
- Temperature: 27.5°C, humidity: 9.6%, pressure in air chamber: no data
TEST ATMOSPHERE
- Brief description of analytical method used: The test atmosphere was sampled at regular intervals during the exposure period. Samples were taken from an unoccupied exposure port (representing the animal's breathing zone) by pulling a suitable volume of test atmosphere through weighed GF10 glass fibre filters (Whatman, Germany, ref. no. 10370302). The difference in the pre and post sampling weights, divided by the volume of atmosphere sampled, was equal to the actual achieved test atmosphere concentration.
- Samples taken from breathing zone: yes. Filter samples were collected at the breathing zone (approx. every 10-20 minutes) during each 4-hour exposure period and analyzed.
VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle size of the test atmosphere was determined three times during the exposure period using a 7-stage impactor of Mercer style (TSE systems GmbH, Bad Homburg, Germany).
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.53µm (MMAD), 2.38 (GSD) (=sighting group); 2.41µm (MMAD), 2.32 (GSD) (=main study). - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.04mg/l
- No. of animals per sex per dose:
- 1 male/female (sighting exposure)
5 male/female (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Morbidity/mortality: 1 hour after exposure and twice daily during the 14-day observation period. Clinical signs: hourly intervals during exposure and twice a day the day of exposure and once daily for 14 days. Bodyweight: on day 1, 3, 7, 14.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: In group 0.1 (sighting exposure): slightly to moderate laboured respiration was recorded up to 1 hour after exposure. In group 1 (main study): slight laboured respiration was observed in all animals during the exposure and shortly thereafter when removed
- Body weight:
- In Group 0.1 as sighting group, slight body weight loss was observed in the male animal. The body weight returned to the initial values on Day 3.
In Group 1, slight body weight loss (1-8%) was observed in all animals, except two female rats (no.: 8236, 8239) where moderate body weight loss (11-12%) was recorded. The body weight of 4 males (no.: 8207, 8210, 8211, 8212) and one female (no.: 8242) returned to the initial values on approximately on Day 3, while a single male (no.: 8209) and 4 female animals (no.: 8236, 8239, 8240, 8241) gained their initial body weight back on approximately Day 7. - Gross pathology:
- There was no evidence of any macroscopic observations at a concentration of 5.04 mg/l in animals terminated on day 14.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, no lethality occurred in Group 0.1 or Group 1 when exposed to an aerosol concentration of 5.04 mg/L each for 4 hours. The acute inhalation median lethal concentration (LC50) of GASIR1 in Wistar Crl:WI rats was therefore considered to be above 5.04 mg/L.
- Executive summary:
1.1. STUDY DESIGN
Wistar Crl:WI rats were exposed to a test atmosphere of GASIR1 at concentration of 5.04 mg/L. The test item was administered as supplied by the Sponsor without any preparation.
The study was performed in two steps. A sighting exposure was performed first, where test atmospheres at concentrations of 5.04 mg/L was tested on single animals of both sexes. No lethality was observed at this concentration. Thereafter the main study was performed at a concentration of 5.04 mg/L. Five male and five female rats were used in the main group (Group 1). In both study phases, the animals were exposed to the test atmosphere for 4 hours using a nose-only exposure system. Aerosol concentration was measured gravimetrically 18 times during each 4-hour exposure in both parts of the study and the particle size distribution of the test aerosol was determined 3 times. The day of exposure was designated Day 0 in both parts of the study and a 14-day observation period followed the exposures.
Clinical observations were performed for all animals during exposure at hourly intervals, following removal from restraint, approximately 1hour following the end of the exposure, and daily for 14 days thereafter. Body weight was measured on Days 0 (before the exposure), 1, 3, 7 and 14. Gross necropsy was performed on the animal that died and on all animals sacrificed on Day 14.
No control group was exposed in this study.
1.2. RESULTS
The quality of the test atmosphere fully complied with criteria documented in the respective guidelines: OECD 403, EPA OPPTS 870.1300 and Council Regulation (EC) No 440/2008.
The mean achieved atmosphere concentration in the study was 5.04 mg/L in both Group 0.1 and Group 1. The mass median aerodynamic diameter (MMAD) was 2.53 μm and 2.41μm with geometric standard deviation (GSD) 2.38 and 2.32 in the Sighting Group and the Main Group, respectively.
Sighting Exposure
Initially, a single male and female rats (Group 0.1) were exposed to the aerosol concentration of 5.04 mg/L. Both animals survived.
The main clinical sign was laboured respiration, slight in the male rat and slight to moderate in the female animal. A slight body weight loss was also observed on Days 0-3 in the male of Group 0.1. The body weight returned to the initial value on Day 3.
At the necropsy, no external or internal finding was recorded in Group 0.1.
Main Study
Mortality
No mortality was noted in Group 1, either during the exposure or during the 14 day observation period.
Clinical findings
In Group 1, slight laboured respiration was observed in all animals during the exposure and shortly thereafter when removed from the restraint tubes. Increased respiratory rate (slight) was also recorded in 3 out of 5 males and in 2 out of 5 females on Day 0. Slightly weak body condition was noted in 2/5 males and 4/5 females and persisted for up to Day 2 in males and up to Day 6 in females. In a single female, moderately weak body condition was observed on Day 1 and Day 2. From Day 7 all animals were symptom-free.
Additionally, fur stained by test item was commonly observed in all animals following the exposure and persisting for up to Day 5. Wet fur was also generally recorded in all animals on the day of exposure. This observation was considered to be related to the restraint and exposure procedures and was considered not to be toxicologically significant.
Body weight
In Group 1, slight body weight loss (1-8%) was observed in all animals, except two female rats where moderate body weight loss (11-12%) was recorded. The body weight of 4 males and one female returned to the initial values on approximately on Day 3, while a single male and 4 female animals gained their initial body weight back on approximately Day 7.
Necropsy
No external or internal finding was recorded at necropsy in Group 1.
1.3. CONCLUSION
Under the experimental conditions of this study, no lethality occurred in Group 0.1 or Group 1 when exposed to an aerosol concentration of 5.04 mg/L each for 4 hours. The acute inhalation median lethal concentration (LC50) of GASIR1 in Wistar Crl:WI rats was therefore considered to be above 5.04 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 5.04 mg/L 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:
- 2011-07-20 to 2011-08-03
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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:Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX France
- Age at study initiation: Young adult rats
- Weight at study initiation: between 210 and 272g
- Housing: individual caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-24 °C
- Humidity (%): 42-69%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light - Type of coverage:
- semiocclusive
- Vehicle:
- other: none
- Details on dermal exposure:
- TEST SITE
- Area of exposure:10% of the total body surface
- % coverage: 100%
- Type of wrap if used: semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed after exposure (24h) with water of body temperature
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test item was placed onto a gauze pad and moistened with water
VEHICLE
- Amount(s) applied (volume or weight with unit): one gauze pad
- Lot/batch no. (if required): 102/26 - Duration of exposure:
- 24h hours
- Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Clinical observation: 1, 5 hours after treatment, then daily for 14 days. Body weighing: day 0, 7, 14
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured after a 24 hour dermal exposure to GASIR 1 followed by a 14-day observation period
- Clinical signs:
- other: No clinical signs were observed
- Other findings:
- Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen at necropsy.
Local dermal signs: Russet staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted up to day 4 in the male and day 8 in the female animals. No other local dermal signs were observed. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item GASIR was found to be higher than 2000mg/kg body weight in male and female RjHan:(WI) Wistar rats.
- Executive summary:
An acute dermal toxicity study was performed with test item GASIR1 in RjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402.
A limit test was carried out at 2000mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows:
Mortality
No mortality occurred.
Systemic clinical signs
No clinical signs were observed after the treatment with the test item or during the 14-day observation period.
Local dermal signs
No local dermal signs were observed during the entire study period. However, russet staining was observed on the skin in all animals after dosing from Day 1 to Day 4 in the males and Day 1 to Day 8 in the female animals.
Body weight
The body weight and body weight gain of GASIR1 treated animals did not show any test item-related effect.
Necropsy
There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen.
Conclusions
The acute dermal median lethal dose (LD50) of the test item GASIR1 was found to be higher than 2000 mg/kg bw in male and female RjHan:(WI) Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the results of the available and reliable acute oral, dermal and inhalation studies, no classification is required for Gasir 1 according to EU CLP.
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