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EC number: 695-595-2 | CAS number: 83395-38-4
- 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
Based on the results of the experiment, it is concluded that single dermal application of prop-2-yn-1-yl 1H-imidazole-1-carboxylate did not reveal any skin reactions when applied to the skin of New Zealand White Rabbits, hence the test item is considered as non-irritant and did not meet the classification criteria according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Physical appearance (with colour): White solid
Purity (as per Certificate of Analysis): 99.7789%
Lot No.: S021110385
Date of Manufacture: 2021.11.3
Date of Expiry: 2023.5.6
Storage Conditions: Cool and dry (+2 to +8ºC) - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Oryctolagus cuniculus
- Details on test animals or test system and environmental conditions:
- Test System
No. of Animals / Test and Sex: Initial Test : 1 Female
Confirmatory Test : 2 Females
(Females used were nulliparous and non-pregnant)
Age at Receipt: 4 to 5 months
Body Weight at Receipt: 2.28372 kg to 2.33094 kg
Animal Identification: Acclimatization period: Cage cards
Treatment period: Cage cards and last 4 digits of the animal number were
written on the ear of each rabbit using black marker pen.
Animal No’s: Nc3676 to Nc3678
Husbandry
a. Environmental Conditions:
Animals were housed under standard laboratory conditions, in an environmentally monitored air-conditioned room with adequate fresh air supply (12 to 15 air changes per hour), room temperature 19.7°C to 22.7°C and relative humidity 48% to 64% with 12 hours fluorescent light and 12 hours dark cycle. The temperature and relative humidity were recorded once daily.
b. Housing:
The animals were housed individually in stainless steel wire mesh cage (Size: L 24 x B 18 x H 18 inches) having facilities for holding pelleted feed and drinking water.
c. Feed:
Altromin Maintenance diet for rabbits – Rich in crude fibre 2123 manufactured by Altromin Spezialfutter GmbH & Co. KG was provided ad libitum to the rabbits throughout the experimental period.
d. Water:
Water was provided ad libitum throughout the experimental period. Deep bore-well water passed through Reverse osmosis unit was provided in plastic water bottle with stainless steel sipper tubes.
Acclimatization:
Healthy young adult animals used for initial test and confirmatory test were acclimatized for a period of six and thirteen days respectively to experimental room conditions prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt.
Preparation of Animals
Approximately 24 hours before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely using an electric hair clipper (approximately 8 cm x 12 cm). Care was taken to avoid abrasion to the skin and the animals with healthy intact skin were used. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- yes, concurrent negative control
- Amount / concentration applied:
- 0.5 g of test item was moistened with 0.5 mL of distilled water
- Duration of treatment / exposure:
- Initial Test: the test patches were applied for 3 minutes, 1 hour and 4 hours respectively.
Confirmatory Test: the test patch was applied for 4 hours exposure period. - Observation period:
- Initial test: The application sites 2 and 3 were scored immediately after patch removal whereas the application sites 1 and 4 were scored immediately after patch removal and approximately at 1, 24, 48 and 72 hours after the patch removal.
Confirmatory test: The application sites 1 and 2 were scored approximately at 1, 24, 48 and 72 hours after patch removal. - Number of animals:
- Initial Test : 1 Female
Confirmatory Test : 2 Females - Details on study design:
- The study was performed in two phases i.e., initial test and confirmatory test. Initial test was performed using one rabbit, there were no corrosive or irritant effects observed in initial test. Hence, the confirmatory test was performed by using two additional rabbits.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 0: No Erythema/Oedema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 0: No Erythema/Oedema
- Other effects:
- No clinical signs of toxicity and mortality were observed in any of the animals in initial test and confirmatory test.
No skin reactions like erythema and oedema were observed in any of the animals in initial test and confirmatory test.
No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 in initial test and confirmatory test animals. All animals revealed normal increase in the body weight during the observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the experiment, it is concluded that single dermal application of prop-2-yn-1-yl 1H-imidazole-1-carboxylate did not reveal any skin reactions when applied to the skin of New Zealand White Rabbits, hence the test item is considered as non-irritant and did not meet the classification criteria according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.
- Executive summary:
The test item prop-2-yn-1-yl 1H-imidazole-1-carboxylate was evaluated for Acute Dermal Irritation/Corrosion in New Zealand White rabbits.
The study was performed in two phases i.e. initial test and confirmatory test. Approximately 24 hours before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely using an electric hair clipper (approximately 8 × 12 cm). The clipped area of skin at left trunk region and right trunk region was divided into four application sites and it was identified as application sites 1, 2, 3 and 4 respectively.
The application site 1 (anterior left trunk region) of the animal was served as untreated control. On application site 2 (posterior left trunk region), site 3 (posterior right trunk region) and site 4 (anterior right trunk region) of the animal, 0.5 g of test item moistened with 0.5 mL of distilled water was applied for 3 minutes, 1 hour and 4 hours respectively. The application sites 2 and 3 were scored immediately after patch removal whereas the application sites 1 and 4 were scored immediately after patch removal and approximately at 1, 24, 48 and 72 hours after the patch removal.
As there was no corrosive effects observed during initial test, the confirmatory test was performed using two additional rabbits. In the confirmatory test, the patches were applied for 4 hours exposure period. Each animal had two application sites. The clipped area of skin at left trunk region and right trunk region were identified as application sites 1 and 2 respectively.
In the confirmatory test, the application site 1 (left trunk region) of each animal was served as untreated control covered with blank cotton gauze. On application site 2 (right trunk region) of each animal, 0.5 g of test item moistened with 0.5 mL of distilled water was applied for 4 hours exposure period and removed after 4 hours. After removal of the test patches, the application sites were washed with distilled water and dried with absorbent cotton without altering the existing response or the integrity of the epidermis. The application sites 1 and 2 were scored approximately at 1, 24, 48 and 72 hours after patch removal.
The mean score across 3 scoring times (24, 48 and 72 hours after patch removal) for both initial test animal and confirmatory test animals was ‘0’ for erythema and oedema grades.
No erythema and oedema was observed at the test item application site in initial test animal and confirmatory test animals.No treatment related clinical signs of toxicity and mortality was observed in initial test animal and confirmatory test animals.
No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 in initial test and confirmatory test animals. All the animals revealed normal increase in the body weight during the observation period.
Reference
INDIVIDUAL ANIMAL SKIN REACTIONS SCORING RECORD
Phase of the Experiment | Animal No. | Sex | Exposure Duration | Application Site | Dose (g/Patch) | Observations | Skin Reactions Score after Patch Removal | Mean Score | ||||
IAR | 1 hr | 24 hrs | 48 hrs | 72 hrs | ||||||||
Initial Test | Nc3676 | Female | 3 min | Site 2 | 0.5 | ERY | 0 | - | - | - | - | - |
EDE | 0 | - | - | - | - | - | ||||||
1 hrs | Site 3 | 0.5 | ERY | 0 | - | - | - | - | - | |||
EDE | 0 | - | - | - | - | - | ||||||
4 hrs | Site 1 | Untreated Control | ERY | 0 | 0 | 0 | 0 | 0 | 0 | |||
EDE | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
4 hrs | Site 4 | 0.5 | ERY | 0 | 0 | 0 | 0 | 0 | 0 | |||
EDE | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Confirmatory Test | Nc3677 | Female | 4 hrs | Site 1 | Untreated Control | ERY | - | 0 | 0 | 0 | 0 | 0 |
EDE | - | 0 | 0 | 0 | 0 | 0 | ||||||
Site 2 | 0.5 | ERY | - | 0 | 0 | 0 | 0 | 0 | ||||
EDE | - | 0 | 0 | 0 | 0 | 0 | ||||||
Nc3678 | Female | 4 hrs | Site 1 | Untreated Control | ERY | - | 0 | 0 | 0 | 0 | 0 | |
EDE | - | 0 | 0 | 0 | 0 | 0 | ||||||
Site 2 | 0.5 | ERY | - | 0 | 0 | 0 | 0 | 0 | ||||
EDE | - | 0 | 0 | 0 | 0 | 0 |
ERY: Erythema; EDE: Oedema; 0: No Erythema/Oedema; min: Minutes; hr/hrs: Hour/Hours; IAR: Immediately after removal of the test patch; - : Not Applicable
Mean Score For Erythema/ Oedema | : | 24 hrs + 48 hrs+ 72 hrs (Observations after patch removal) |
3 (Observation time point) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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