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Registration Dossier
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EC number: 205-517-7 | CAS number: 141-98-0
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- "No sensitisation (0/20)"
- Author:
- Proctor & Gamble, Brussels(1980)
- Year:
- 1 980
- Bibliographic source:
- Unpublished data.
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- O-isopropyl ethylthiocarbamate
- EC Number:
- 205-517-7
- EC Name:
- O-isopropyl ethylthiocarbamate
- Cas Number:
- 141-98-0
- Molecular formula:
- C6H13NOS
- IUPAC Name:
- N-ethyl(propan-2-yloxy)carbothioamide
- Test material form:
- liquid
- Details on test material:
- IPETC is prepared through reacting ethoxycarbonyl isothiocyanate/ Ethyl isothiocyanatoformate (CAS 16182-04-0) with propan-2-ol/ isopropyl alcohol (CAS Number 67-63-0) and Butan-1-ol/ butyl alcohol (CAS Number 71-36-3).
IPETC/O-isopropyl ethylthiocarbamate contains propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) which are an integral part of the substance.
Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) are both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamate. Therefore, Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate.
EC Name: propan-2-ol
CAS Number :67-63-0
EC Number:200-661-7
CAS Name: isopropyl alcohol
EC Name: Butan-1-ol
CAS Number : 71-36-3
EC Number: 200-751-6
CAS Name: butyl alcohol
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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.
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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