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Diss Factsheets

Administrative data

Description of key information

White spirit (Stoddard solvent containing 14.5% aromatics) was found not to be sensitizing in a Buehler test. A 75% (by volume) solution of white spirit (Stoddard solvent) in a vehicle of paraffin oil used for the three sensitizing doses was found to induce mild to moderate irritation. A 25% (by volume) solution was used as a challenge dose.

Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.

Results: No evidence of sensitization

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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler Test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
Specific details on test material used for the study:
Stoddard solvent (8052-41-3) Aromatics 14.5 (%), Boiling Point Range 160-199 °C

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Shizuoka
- Age at study initiation: 5 weeks
- Weight at study initiation: 313-337 g
- Housing: animals were housed in aluminium cages with stainless steel wire mesh floors (350 mm x 400 mm x 200 mm, Natsume Seisakusyo Co., Tokyo); 5 animals/cage.
- Diet (e.g. ad libitum): standard pelleted diet for guinea-pigs (RC-4; Oriental Yeast Co.) ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):23±2
- Humidity (%): 50±10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12hrs light

IN-LIFE DATES: 19-Jun-1997 to 04-Sep-1997
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
75% (v/v) in paraffin oil for induction
Day(s)/duration:
three weeks
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
25% (v/v) solution in paraffin oil challenge dose
No. of animals per dose:
10 test, 5 control
Details on study design:
Ten male Hartley guinea pigs were treated once a week for three weeks with 0.4 ml of 75% test substance in paraffin oil.
Two weeks after final application, they were challenged with 0.4 ml of 25% test substance in paraffin oil.
Scores were taken at 24 and 48 hours.
A vehicle control group was tested using paraffin oil only; a naïve control group was tested in the challenge phase only; a positive control group was tested using dilute solutions of 2,4-dinitrochlorobenzene.
Challenge controls:
A 25% (by volume) solution was used as a challenge dose
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene
Positive control results:
Evidence presented over a relevant time period that the strain of guinea pig did respond to known sensitisers.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
Remarks on result:
other: see Remark
Remarks:
There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test.

White spirit (Stoddard solvent containing 14.5% aromatics) was found not to be sensitizing in a Buehler test. A 75% (by volume) solution of white spirit (Stoddard solvent) in a vehicle of paraffin oil used for the three sensitizing doses was found to induce mild to moderate irritation. A 25% (by volume) solution was used as a challenge dose.

Interpretation of results:
other: not sensitising
Conclusions:
Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
Results: No evidence of sensitization
Executive summary:

Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.

Results: No evidence of sensitization

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Exposure to mice of 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized Stoddard solvent (140° Flash Aliphatic Solvent)
GLP compliance:
not specified
Specific details on test material used for the study:
Stoddard solvent (140° Flash Aliphatic Solvent)
Species:
mouse
Strain:
Swiss Webster
Sex:
male
Details on test animals or test system and environmental conditions:
six male Swiss-Webster mice
Route of induction exposure:
inhalation
Route of challenge exposure:
inhalation
Vehicle:
unchanged (no vehicle)
Concentration:
350 mg/m, 1200 mg/m3 , 3200 mg/m3 , 4400 mg/m3, 10 000 mg/m3
No. of animals per dose:
six male Swiss-Webster mice
Details on study design:
Exposure to Swiss-Webster mice (vapour plus aerosol) at concentration of 350 mg/m, 1200 mg/m3 , 3200 mg/m3 , 4400 mg/m3, 10 000 mg/m3
Results:
There was used respiratory depression in mice as an index of irritative response in the upper respiratory tract. Three of six male Swiss-Webster mice developed a decline in respiratory rate (below 50% of the normal rate) during 1 min of exposure to 10 000 mg/m3 (1700 ppm vapour and aerosols) of white spirit (Stoddard solvent; 15% aromatics). A similar decrease in respiratory rate did not occur at 4400 mg/m3 (770 ppm).
Exposure to mice of either 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate
Interpretation of results:
other: not respiratory irritation
Conclusions:
There was used respiratory depression in mice as an index of irritative response in the upper respiratory tract. Three of six male Swiss-Webster mice developed a decline in respiratory rate (below 50% of the normal rate) during 1 min of exposure to 10 000 mg/m3 (1700 ppm vapour and aerosols) of white spirit (Stoddard solvent; 15% aromatics). A similar decrease in respiratory rate did not occur at 4400 mg/m3 (770 ppm).
Exposure to mice of either 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

 Exposure to mice of either 350 mg/m3(56 ppm vapour) or 1200 mg/m3(vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate

Justification for classification or non-classification

Based on the hazard assessment ofStoddard solventin 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”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according 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 Stoddard solvent does not meet the criteria to be classified for human health hazards for Inhalation-local effect:respiratory irritation/corrosion and/or respiratory sensitisation.