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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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 Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol. Therefore, Propan-2-ol (Isopropyl alcohol) need to be considered in the assessment of Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol .
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. 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.
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:
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 Reaction mass of O-isopropyl ethylthiocarbamate (85%-98%) and n-butanol (1%-10%) and propan-2-ol (1%-5%) 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.

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 ofReaction mass of O-isopropyl ethylthiocarbamate (85%-98%) and n-butanol (1%-10%) and propan-2-ol (1%-5%)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 Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol 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
Reference
Endpoint:
respiratory sensitisation: in vivo
Data waiving:
other justification
Justification for data waiving:
other:
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 ofReaction mass of O-isopropyl ethylthiocarbamate (85%-98%) and n-butanol (1%-10%) and propan-2-ol (1%-5%)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 Reaction mass of O-isopropyl ethylthiocarbamate (85%-98%) and n-butanol (1%-10%) and propan-2-ol (1%-5%) 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 Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol

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 Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol

does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.