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EC number: 206-016-6 | CAS number: 287-92-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is in compliance with the OCED principles of GLPs.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is in compliance with the OCED principles of GLPs.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- reference to same study
- Positive control results:
- not reported
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% ethanol (0.4 mL)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% ethanol (0.4 mL). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No treatment-related clinical signs observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No treatment-related clinical signs observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB in acetone
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- slight to severe erythema and edema were observed at 24 and 48 hours post challenge
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% DNCB in acetone. No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations: slight to severe erythema and edema were observed at 24 and 48 hours post challenge.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- n-Pentane showed no irritation or sensitization potential after intradermal and topical application in Guinea pigs (experimental days one and seven), followed by occluded dermal challenge on day 21. n-Pentane is not a dermal sensitiser.
- Executive summary:
This data is being read across from the source study that tested pentane based on analogue read across.
A dermal sensitisation study was conducted in guinea pigs (20 females/dose; 15 females for positive control) using n-pentane.
Induction Phase: An area near the scapula in the mid-dorsal region of all animals was clipped on the day prior to intradermal injection of tbe test material and/or carrier. 6 intradermal injections (0.1 mL each) were administered to 3 different sites as follows: Site 1: FCA/water to treated and control groups; Site 2: 5.0% n-pentane in carrier (ethanol) to the treated group, 100% ethanol to the control group; Site 3: 5.0% n-pentane in FCA/Water to the treated group, 5.0% carrier (reverse osmosis water) in FCA/Water to the control group. On day 7 following injection, 0.5 mL of a mild to moderately irritating dose of n-pentane was administered topically over the previously injected areas and covered with occlusive wrapping. Control animals received topical carrier applications instead.
Challenge Phase: 21 days post induction phase, 0.1 mL of n-pentane (1.0% in ethanol) was applied topically to the left flank of both treated and control irritation groups. 0.4 mL of the carrier (ethanol) was applied to the right flank. All applications were kept secure under occlusive wrapping for 24 hours and animals observed for dermal effects for 48 hours.
Sensitization was evaluated by comparing the reactions of treated animals with the reactions of control animals that received a single epidermal exposure to the test material. Control responses were used to distinguish true sensitization from local irritation produced by the same concentration of test material.
All animals survived to study termination and displayed a weight gain from their day 0 values. Abnormal clinical observations during scheduled intervals were limited to one treated group animal that was emaciated and had a small amount of stool. Another animal exhibited slight emaciation and poor food consumption. Clinical signs observed in these two animals were considered to be correlated to the stress of the wrapping procedure and not treatment-related. No signs of dermal irritation were observed at any dose in either patch group. DNCB elicited positive reactions from all tested animals 24 and 48 hours after removal of the patch challenge.
Based on the lack of signs dermal irritation observed in the study, n-pentane is not considered a dermal sensitiser. This study was given a Klimisch score of 1 and classified as reliable without restriction because it is in compliance with the OCED principles of GLPs.
Table 1. Incidence of Challenge in Guinea Pig - Ethanol |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group |
||||||
24 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
24 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
Treatment Group |
||||||
24 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
24 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
Table 2. Incidence of Challenge in Guinea Pig – MRD-91-962 |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group |
||||||
24 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
24 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
Treatment Group |
||||||
24 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
24 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
Table 3. Incidence of Challenge in Guinea Pig – DNCB (Positive Control) |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group - Acetone |
||||||
24 hr erythema |
15 |
15 |
0 |
0 |
0 |
0 |
24 hr edema |
15 |
15 |
0 |
0 |
0 |
0 |
48 hr erythema |
15 |
15 |
0 |
0 |
0 |
0 |
48 hr edema |
15 |
15 |
0 |
0 |
0 |
0 |
Treatment Group – 0.1% DNCB in Acetone |
||||||
24 hr erythema |
15 |
0 |
0 |
9 |
6 |
0 |
24 hr edema |
15 |
6 |
5 |
4 |
0 |
0 |
48 hr erythema |
15 |
0 |
3 |
7 |
0 |
5 |
48 hr edema |
15 |
5 |
3 |
7 |
0 |
0 |
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- Pentane
- EC Number:
- 203-692-4
- EC Name:
- Pentane
- Cas Number:
- 109-66-0
- Molecular formula:
- C5H12
- IUPAC Name:
- pentane
- Details on test material:
- - Name of test material (as cited in study report): MRD-91-962
- Physical state: liquid
- Analytical purity: not reported
- Lot/batch No.: III
- Stability under test conditions: stable at room temperature
- Storage condition of test material: room temperature
- Other: clear, colorless liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, Pennsylvania
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: 324 to 409 grams
- Housing: Individual (during test period) in suspended stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.33 to 21.67°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light
IN-LIFE DATES: From: 1991-07-21 To: 1991-09-04
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant (FCA)
- Concentration / amount:
- Induction Phase: 5% n-pentane in ethanol (Site 2); 5% n-pentane in FCA/Water (Site 3)
Challenge Phase: 1% n-pentane in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freund's Complete Adjuvant (FCA)
- Concentration / amount:
- Induction Phase: 5% n-pentane in ethanol (Site 2); 5% n-pentane in FCA/Water (Site 3)
Challenge Phase: 1% n-pentane in ethanol
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Test groups: FCA/Water; n-pentane in ethanol; n-pentane in FCA/Water
- Control group: FCA/Water; Ethanol; 5% Reverse Osmosis Water in FCA/Water
- Site: Mid-dorsal region, near the scapula
- Duration: 0 to 7 days
- Concentrations: same throughout
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: n-pentane
- Control group: Ethanol
- Site: L Flank - n-pentane; R Flank - Carrier (ethanol)
- Concentrations: 1.0% n-pentane in ethanol
- Evaluation (hr after challenge): 24, 48
- Challenge controls:
- 0.4 mL of carrier - ethanol (100% ) was administered topically to guinea pigs in the treatment and irritation control groups
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- not reported
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% ethanol (0.4 mL)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% ethanol (0.4 mL). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No treatment-related clinical signs observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No treatment-related clinical signs observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB in acetone
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- slight to severe erythema and edema were observed at 24 and 48 hours post challenge
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% DNCB in acetone. No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations: slight to severe erythema and edema were observed at 24 and 48 hours post challenge.
Any other information on results incl. tables
Table 1. Incidence of Challenge in Guinea Pig - Ethanol |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group |
||||||
24 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
24 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
Treatment Group |
||||||
24 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
24 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
Table 2. Incidence of Challenge in Guinea Pig – MRD-91-962 |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group |
||||||
24 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
24 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr erythema |
10 |
10 |
0 |
0 |
0 |
0 |
48 hr edema |
10 |
10 |
0 |
0 |
0 |
0 |
Treatment Group |
||||||
24 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
24 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr erythema |
20 |
20 |
0 |
0 |
0 |
0 |
48 hr edema |
20 |
20 |
0 |
0 |
0 |
0 |
Table 3. Incidence of Challenge in Guinea Pig – DNCB (Positive Control) |
||||||
Dermal Observation |
Dermal Score |
|||||
No. of animals |
0 |
1 |
2 |
3 |
4 |
|
Irritation Control Group - Acetone |
||||||
24 hr erythema |
15 |
15 |
0 |
0 |
0 |
0 |
24 hr edema |
15 |
15 |
0 |
0 |
0 |
0 |
48 hr erythema |
15 |
15 |
0 |
0 |
0 |
0 |
48 hr edema |
15 |
15 |
0 |
0 |
0 |
0 |
Treatment Group – 0.1% DNCB in Acetone |
||||||
24 hr erythema |
15 |
0 |
0 |
9 |
6 |
0 |
24 hr edema |
15 |
6 |
5 |
4 |
0 |
0 |
48 hr erythema |
15 |
0 |
3 |
7 |
0 |
5 |
48 hr edema |
15 |
5 |
3 |
7 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- n-Pentane showed no irritation or sensitization potential after intradermal and topical application in Guinea pigs (experimental days one and seven), followed by occluded dermal challenge on day 21. n-Pentane is not a dermal sensitiser.
- Executive summary:
A dermal sensitisation study was conducted in guinea pigs (20 females/dose; 15 females for positive control) using n-pentane.
Induction Phase: An area near the scapula in the mid-dorsal region of all animals was clipped on the day prior to intradermal injection of tbe test material and/or carrier. 6 intradermal injections (0.1 mL each) were administered to 3 different sites as follows: Site 1: FCA/water to treated and control groups; Site 2: 5.0% n-pentane in carrier (ethanol) to the treated group, 100% ethanol to the control group; Site 3: 5.0% n-pentane in FCA/Water to the treated group, 5.0% carrier (reverse osmosis water) in FCA/Water to the control group. On day 7 following injection, 0.5 mL of a mild to moderately irritating dose of n-pentane was administered topically over the previously injected areas and covered with occlusive wrapping. Control animals received topical carrier applications instead.
Challenge Phase: 21 days post induction phase, 0.1 mL of n-pentane (1.0% in ethanol) was applied topically to the left flank of both treated and control irritation groups. 0.4 mL of the carrier (ethanol) was applied to the right flank. All applications were kept secure under occlusive wrapping for 24 hours and animals observed for dermal effects for 48 hours.
Sensitization was evaluated by comparing the reactions of treated animals with the reactions of control animals that received a single epidermal exposure to the test material. Control responses were used to distinguish true sensitization from local irritation produced by the same concentration of test material.
All animals survived to study termination and displayed a weight gain from their day 0 values. Abnormal clinical observations during scheduled intervals were limited to one treated group animal that was emaciated and had a small amount of stool. Another animal exhibited slight emaciation and poor food consumption. Clinical signs observed in these two animals were considered to be correlated to the stress of the wrapping procedure and not treatment-related. No signs of dermal irritation were observed at any dose in either patch group. DNCB elicited positive reactions from all tested animals 24 and 48 hours after removal of the patch challenge.
Based on the lack of signs dermal irritation observed in the study, n-pentane is not considered a dermal sensitiser. This study was given a Klimisch score of 1 and classified as reliable without restriction because it is in compliance with the OCED principles of GLPs.
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