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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is classified as reliable without restriction because it complies with acceptable guideline requirements and adheres to GLP standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Alkenes, C6-8
IUPAC Name:
Alkenes, C6-8
Details on test material:
- Name of test material (as cited in study report): SHOP C68 Internal Olefin
- Substance type: Alkenes, C6-8
- Physical state: Liquid (clear, colourless)
- Lot/batch No.: 168082
- Storage condition of test material: Cool conditions (not exceeding 15 degrees C), under nitrogen, protected from light, in the original container.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall, Darley Oaks, Newchurch, Burton on Trent, Staffordshire, England
- Age at study initiation: 6 to 8 weeks
- Housing: Stainless steel cages, with grid floors and tops. Grid floors ensured rapid removal of waste material to undertrays which were cleaned out as necessary. No more than five animals of the same sex were assigned to each cage. Cages were suspended in mobile stainless steel racks.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 40 to 57
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
First Induction: 50% v/v SHOP C68 in vehicle
Second Induction: 100% SHOP C68 as supplied
Challenge: 100% SHOP C68 as supplied, 30% v/v SHOP C68 in vehicle
Re-challenge: 50% v/v SHOP C68 in paraffin oil (on basis of results of first challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
First Induction: 50% v/v SHOP C68 in vehicle
Second Induction: 100% SHOP C68 as supplied
Challenge: 100% SHOP C68 as supplied, 30% v/v SHOP C68 in vehicle
Re-challenge: 50% v/v SHOP C68 in paraffin oil (on basis of results of first challenge)
No. of animals per dose:
Test group: 20 animals
Control group: 10 animals
(evenly distributed by sex)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 20
- Exposure period: Day 1 to day 8
- Test groups: 20 animals (all animals received FCA, test material in vehicle, and test material in FCA at 3 different sites)
- Control group: 10 animals (all animals received FCA, vehicle, and vehicle in FCA at 3 different sites)
- Site: Intradermal injection-anterior, middle, and posterior sites. topical application-dermal site overlaying scalpulae
- Frequency of applications: Day 1 and day 8
- Concentrations: Intradermal injection: 3 pairs of 0.1mL injections, Topical application-0.6mL test material or vehicle

B. CHALLENGE EXPOSURE
- No. of exposures: 20
- Day(s) of challenge: On day 22
- Exposure period: 24 hours
- Test groups: 20
- Control group: 10
- Site: Both flanks of all animals clipped on day 21 and wet shaven to reveal a 5x5cm area on left flank and 10x5cm area on right flank
- Concentrations: Left site: 0.03 mL vehicle, right site: 0.03 mL of 100% SHOP C68 as supplied and 0.03 mL of 30% v/v SHOP C68
- Evaluation (hr after challenge): 24 and 48 hours after removal of occlusive dressings
Challenge controls:
Control animals were treated identically to test animals during challenge and re-challenge dosing.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% SHOP C68 as supplied
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% SHOP C68 as supplied. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% SHOP C68 as supplied
No. with + reactions:
4
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% SHOP C68 as supplied. No with. + reactions: 4.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% SHOP C68 as supplied
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% SHOP C68 as supplied. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% SHOP C68 as supplied
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% SHOP C68 as supplied. No with. + reactions: 16.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30% v/v SHOP C68 in vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30% v/v SHOP C68 in vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30% v/v SHOP C68 in vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one animal killed on day 24
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30% v/v SHOP C68 in vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one animal killed on day 24.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% v/v SHOP C68 in vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% v/v SHOP C68 in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30% v/v SHOP C68 in vehicle
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% v/v SHOP C68 in vehicle. No with. + reactions: 5.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Intradermal injection of 50% v/v/ SHOP C68 in paraffin oil gave rise to low incidences of slight or moderate erythema and pallor, a similar administration of 50% v/v/ SHOP C68 in paraffin oil in FCA resulted in slight or moderate erythema, pallor, discolouration, eschar formation and oedema. The entire suprascapular region of five animals was oedematous. Occluded topical induction application gave rise to slight erythema and exfoliation.

Challenge application of SHOP C68 as supplied gave rise to eschar formation and/or oedema in fifteen test and two control animals, a further one test and two control animals showed slight erythema. Exfoliation was evident in three test and four control animals. Challenge application of 30% v/v SHOP C68 in paraffin oil gave rise to slight erythema in five test and no control animals. Exfoliation was evident in four test and two control animals. Challenge application of paraffin oil alone gave rise to a single case of slight erythema with exfoliation amongst the test animals.

Re-challenge application of 50% v/v SHOP C68 in paraffin oil gave rise to slight erythema and exfoliation in two test and one control animal. Re-challenge application of paraffin oil gave rise to slight erythema and exfoliation in one test animal; no reaction was evident amongst the controls.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, repeated applications of SHOP C68 did not cause delayed contact hypersensitivity in the guinea-pig.
Executive summary:

In a dermal sensitization study using SHOP C68 in paraffin oil, Dunkin Hartley albino Guinea pigs (10 male/10 female) were tested using the method of the guinea pig maximization test according to OECD guideline 406.

 

SHOP C68 Internal Olefins applied topically at 100% (neat, as supplied) resulted in slight erythema or a more marked response at 48 hours in 16/20 test and 4/9 control animals. Topical application of 30% v/v SHOP C68 in paraffin oil produced a positive response in 5/20 test and 0/10 control animals while re-challenge with 50% v/v SHOP C68 in paraffin oil resulted in a positive response in 2/20 test and 1/9 control animals. The slightly increased positive response of test animals compared to controls was not considered to be delayed contact sensitivity by the study authors, but was designated as primary irritation. SHOP C68 did not cause delayed contact hypersensitivity under the study conditions, and is thus not considered a dermal sensitizer.

 

This study received a Klimisch score of 1 and is classified asas reliable without restriction because it complies with acceptable guideline requirements and adheres to GLP standards.