Registration Dossier
Registration Dossier
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EC number: 232-489-3 | CAS number: 8052-41-3 A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
Skin sensitisation
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- Stoddard solvent
- EC Number:
- 232-489-3
- EC Name:
- Stoddard solvent
- Cas Number:
- 8052-41-3
- Molecular formula:
- C10H22
- IUPAC Name:
- stoddard solvent
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Stoddard solvent (8052-41-3) Aromatics 14.5 (%), Boiling Point Range 160-199 °C
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 75% (v/v) in paraffin oil for induction
- Day(s)/duration:
- three weeks
Challenge
- 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
Results and discussion
- Positive control results:
- Evidence presented over a relevant time period that the strain of guinea pig did respond to known sensitisers.
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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
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