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EC number: 211-687-3 | CAS number: 686-31-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1A: GLP, OECD N°406 Guideline (1992, July 17th)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- date of study is before official adoption of LLNA guideline
Test material
- Reference substance name:
- tert-pentyl 2-ethylperoxyhexanoate
- EC Number:
- 211-687-3
- EC Name:
- tert-pentyl 2-ethylperoxyhexanoate
- Cas Number:
- 686-31-7
- Molecular formula:
- C13H26O3
- IUPAC Name:
- 2-methylbutan-2-yl 2-ethylhexaneperoxoate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- . labelling: t-AMYL PEROXYETHYL-2-HEXANOATE LUPEROX575
. batch number: 616-9809-715 (19/09/98)
. Elf Atochem filing number: CAL 4099/98
. description: whitish liquid
. container: one plastic flask
. date of receipt: 16 December 1998
. storage conditions: at +4° C and protected from light
. expiry date: June 1999.
. Purity: tehcnically
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species and strain: Dunkin-Hartley guinea-pigs.
- Reason for this choice: species generally accepted by regulatory authorities for this type of study. The strain used has been shown to produce a satisfactory sensitization response using known sensitizers.
- Breeder: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France.
- two males and two females for the preliminary test,
- Females were nulliparous and non-pregnant.
-Weight: on day 1, the animals of the main test were approximately 3 months old and bad a mean body weight ± standard deviation of 369 ± 24 g for the males and 362 ± 18 g for the females.
- Acclimatization: at least 5 days before the beginning of the study.
- Identification of the animals: ear-tattoo.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5%
cutaneous induction: undiluted
cutaneous challenge: undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5%
cutaneous induction: undiluted
cutaneous challenge: undiluted
- No. of animals per dose:
- Control group: 5 males and 5 females
Treated group: 10 males and 10 females - Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
* Intradermal induction:
- On day 1, 3injections are realized on the scapular area:
- 0.1mL of Freund's complete adjuvant at 50% in 0.9% NaCl
- 0.1mL of the test item at 5 % (for treated group) or 0.1mL of vehicle (for control group)
- 0.1mL of a mixture 50/50 (V/V) of Freund's complete adjuvant in 0.9% NaCl and the test item at 5 % (for treated group) or the vehicle (for control group).
* Cutaneous induction:
- On day 7, local irritation is induced by application of Sodium Laurylsulfate 10% in Vaseline
- On day 8, occlusive application on the scapular area of 0.5mL of the test item 10% (for treated group) or vehicle (for control group) for 48 hours
B. CHALLENGE EXPOSURE D22
On day 22, 24hours occlusive application on the scapular area of 0.5mL of the undiluted test item on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 24 and 48 hours after removal of the dressing - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- Date-Study n°CIT/Study No. 17335 TSG; dinitrochlorobenzene
Results and discussion
- Positive control results:
- Dinitro 2,4 Chlorobenzene : Positive result in recent study on ( ) females. Induction: test substance injected intradermally 0.05% (d1) and applied cutaneously 0.5% (d8). Challenge (d22): 0,1% r flank 0.5% l flank
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- score of more than 2 were considered positive
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: score of more than 2 were considered positive.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- only dryness of the skin was observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only dryness of the skin was observed.
Any other information on results incl. tables
Individual scoring:
Group |
Sex |
Animal |
24h |
48h |
||||||
Erythema |
Oedema |
Erythema |
Oedema |
|||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
|||
Control |
M |
31 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
34 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
35 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Control |
F |
46 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
47 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
49 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Treated |
M |
36 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
37 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
38 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
39 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
40 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
41 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
42 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
43 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
44 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
45 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
|
||||||||||
Treated |
F |
51 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
52 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
53 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
54 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
55 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
56 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
57 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
58 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
59 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
60 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
LF=left flank
RF=right flank
A=crusts
S=dryness of the skin
No cutaneous reactions were observed in the animals of the control group.
In the treated group, at the 24-hour reading, a very slight (grade 1) or well-defined (grade 2)
erythema was noted in 8/20 and 9/20 animals, respectively.
No erythema persisted at the 48-hour reading. Dryness of the skin was observed in
12/20 animals.
The observed erythema with a score higher than 1 were considered as delayed contact hypersensitivity reactions.
no visible change.............................................................................................0
discrete or patchy erythema.............................................................................1
moderate and confluent erythema.....................................................................2
intense erythema..............................................................................................3
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under these experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance t-amy peroxyethyl-2-hexanoate induces delayed contact hypersensitivity in 9/20 (45%) guinea-pigs, with an intradermal induction dose of 5 % and undiluted substance for cutaneous application.
- Executive summary:
The delayed contact hypersensivity of t-amy peroxyethyl-2-hexanoate was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test) and in compliance with GLP.
The induction phase has been realized both by intradermal route on day 1 (5in vehicle) and by cutaneous route on day 8 (undiluted) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of the undiluted substance on the right flank (vehicle on the left flank); the cutaneous reactions were scored 24 and 48 hours after the challenge phase.
No cutaneous reactions were observed in the animals of the control group. In the treated group, at the 24-hour reading, a very slight (grade 1) or well-defined (grade 2) erythema was noted in 8/20 and 9/20 animals, respectively. No erythema persisted at the 48-hour reading. Dryness of the skin was observed in12/20 animals. The observed erythema with a score higher than 1 were considered as delayed contact hypersensitivity reactions.
In conclusion, the test item was considered as sensitizing in guinea pigs.
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