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EC number: 205-517-7 | CAS number: 141-98-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Propan-2-ol (Isopropyl alcohol) is both reagents used in the manufacture of IPETC/ O-isopropyl ethylthiocarbamatel. Therefore, Propan-2-ol (Isopropyl alcohol) need to be considered in the assessment of IPETC/ O-isopropyl ethylthiocarbamate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- cclimation perios is 4 days instead of 5 days.Pre and post study body weight not mentioned in the report
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This test determined the potential of the test substance to be sensitizing to skin.
20 animals in the test substance group and 10 animals in the vehicle control were treated with 100% Isopropyl alcohol
Four animals were exposed for 6 hours period to various concentrations of the test substance - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Murphy Breeding Laboratories
- Age at study initiation: Not available
- Weight at study initiation: Not available
- Housing: housed singly in wire mesh cages
- Diet (e.g. ad libitum): Purina Laboratory Guinea Pig chow , ad libitum
- Water (e.g. ad libitum): animals were maintained on medicated water containing 4% of sulfaethoxypyridazine for four days and after that they were
furnished with non-medicated water, ad libitum
- Acclimation period: atleast 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not available
- Humidity (%): Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hour light /12 hour dark cycle
IN-LIFE DATES: From: 1980-08-08 To: 1980-09-06 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- One group of 20 test animals was treated with 0.4ml of 100% Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 100% Isopropyl alcohol. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- One group of 20 test animals was treated with 0.4ml of 100% Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 100% Isopropyl alcohol. - No. of animals per dose:
- 20 animals in the test substance group and 10 animals in the vehicle control were treated with 100% Isopropyl alcohol
- Details on study design:
- RANGE FINDING TESTS: Four animals were exposed for 6 hours period to various concentrations of the test substance
Concentration: 100%, 50%, 25%, 10% v/v solution in distilled water
Exposure period: 24 hours
Grading: the patch site were scored for irritation four to five hours later after washing
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 induction exposure
- Exposure period: 6 hours
- Test groups: 0.4 ml of undiluted test substance
- Control group: none
- Site: upper left quadrant of the backs of the test animals
- Frequency of applications: once a week for 3 weeks
- Duration: 6 hours webril patches under occlusion
- Concentrations: 0.4 ml of undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: one 6 hour exposure
- Day(s) of challenge: two weeks after second induction
- Exposure period: 6 hours under occlusion
- Test groups: 0.4 ml of undiluted test substance
- Control group: 0.4 ml of undiluted test substance
- Site: lower left quedrant of the back of the test animals
- Concentrations: 0.4 ml of undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after challenge exposure
OTHER: None - Challenge controls:
- 10 animals treated with 100% Isopropyl alcohol
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% Isopropyl alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% Isopropyl alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100% Isopropyl alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% Isopropyl alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% Isopropyl alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Isopropyl alcohol did not induce sensitization in the guinea pig model.
Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate did not induce sensitization in the guinea pig model. - Executive summary:
One group of 20 test animals was treated with undiluted Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposures. The test animals and control animals were challenged with undiluted Isopropyl alcohol. No skin reactions were observed in the test and control animals therefore, it was concluded that Isopropyl alcohol is not a sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
Isopropyl alcohol did not induce sensitization in the guinea pig model.
Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/O-isopropyl ethylthiocarbamate did not induce sensitization in the guinea pig model.
One group of 20 test animals was treated with undiluted Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposures. The test animals and control animals were challenged with undiluted Isopropyl alcohol. No skin reactions were observed in the test and control animals therefore, it was concluded that Isopropyl alcohol is not a sensitizer.
Synopsis
Not sensitising
Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance IPETC/ O-isopropyl ethylthiocarbamate does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Respiratory sensitisation.
The results of the study (Burleigh-Flayer H, Garman R, Neptun D, Bevan C, Gardiner T, Kapp R, Tyler T & Wright G 1997) indicate that Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate has not an adverse effect at concentration of 5000 ppm on kidneys in rats. Macroscopic changes such as granular kidney were noted in males and females of 2500 and 5000 ppm groups. A number of non-neoplastic histopathological changes were observed, with the most significant being in the kidney. The only neoplastic change observed was in male rats and was an increase in interstitial cell adenomas of the testis considered to represent marked hyperplasia and not autonomous growth.
There were no treatment-related changes in the haematological or urinalysis values in any of the animals. No signs of irritation of respiratory tract and Nasal effects were observedin rats as reddish nasal discharge and also not respiratory sensitisation were observed.
Synopsis
Not Sensitising
Migrated from Short description of key information:
The results of the study (Burleigh-Flayer H, Garman R, Neptun D, Bevan C, Gardiner T, Kapp R, Tyler T & Wright G 1997) indicate that Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/O-isopropyl ethylthiocarbamate has not an adverse effect at concentration of 5000 ppm on kidneys in rats. Macroscopic changes such as granular kidney were noted in males and females of 2500 and 5000 ppm groups. A number of non-neoplastic histopathological changes were observed, with the most significant being in the kidney. The only neoplastic change observed was in male rats and was an increase in interstitial cell adenomas of the testis considered to represent marked hyperplasia and not autonomous growth.
There were no treatment-related changes in the haematological or urinalysis values in any of the animals. No signs of irritation of respiratory tract and Nasal effects were observed in rats as reddish nasal discharge and also not respiratory sensitisation were observed.
Justification for classification or non-classification
Based on the hazard assessment of IPETC/ O-isopropyl ethylthiocarbamate
section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system |
CLP |
Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance IPETC/O-isopropyl ethylthiocarbamate
does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.
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