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EC number: 421-820-9 | CAS number: 192268-65-8 CD 28-0132; IRGALUBE 232
Skin sensitisation
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EWG, B.6 (Guinea Pig maximization test (GPMT))
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
- EC Number:
- 421-820-9
- EC Name:
- A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
- Cas Number:
- 192268-65-8
- Molecular formula:
- Unspecified
- IUPAC Name:
- O,O,O-triphenyl phosphorothioate; O-2,4-di-tert-butylphenyl O,O-diphenyl phosphorothioate; O-2-tert-butylphenyl O,O-diphenyl phosphorothioate; O-2-tert-butylphenyl O-4-tert-butylphenyl O-phenyl phosphorothioate; O-4-tert-butylphenyl O,O-diphenyl phosphorothioate
- Details on test material:
- - Appearance: yellowish liquid.
- Storage condition of test material: Room temperature in dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Age at study initiation: Approximately four to five weeks of age.
- Weight at study initiation: 292 to 339 g.
- Housing: in groups of five in suspended metal cages with wire mesh floors
- Diet: ad libitum (A vitamin C enriched guinea-pig diet FD2; hay was given weekly) diet was not analysed for nutrients, possible contaminants or microorganisms.
- Water: ad libitum (analysed weekly for contamination).
- Acclimation period: For five days prior to allocation to the main study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.
- Humidity (%): 30 - 70.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
An additional six animals, from the same supplier, were used for the preliminary investigations.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- coconut oil
- Concentration / amount:
- 1 % v/v in Alembicol D (A product of coconut oil, supplied by Alembic Products, Saltney, Chester, England)
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 100 %
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Concentration / amount:
- 100 % and 50 % v/v in Alembicol D.
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 5
- Details on study design:
- RANGE FINDING TESTS:
Animals for these investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 50:50 with water for irrigation (Ph. Eur), approximately two weeks prior to the start of the preliminary investigations.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection
- Site/Area: Back (scapular region)/2 x 4 cm
- No. of injections/animal: 6 injections in pairs each.
- Test substance group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with water (Ph.Eur.).
- Test substance group (middle; 2 injections side by side): The test article (1%) in vehicle.
- Test substance group (caudal; 2 injections side by side): 50% Freund's complete adjuvant blended (1:1, v/v) with water + 1 % test article in vehicle.
- Control group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with water (Ph.Eur.).
- Control group (middle; 2 injections side by side): Vehicle.
- Control group (caudal; 2 injections side by side): 50% Freund's complete adjuvant blended (1:1, v/v) with water + vehicle
- Volume per injection: 0.1 ml
- Evaluation (hr after injection): from 24 hour till day 7
- Exposure period: Single exposure
Epicutaneous induction exposure
- Time schedule: 7 days after intradermal injection
- Site: same as intradermal injections (site was pretreated 24 hours before with 0.5 ml per site of 10% w/w sodium lauryl sulphate in petrolatum)
- Frequency of applications: Once.
- Area of application: 2 x 4 cm (on Whatman No. 3)
- Concentrations: undiluted test article (test group) and water (control group)
- Volume applied: 0.4ml/animal
- Type of coverage: occlusive (impemeable plastic adhesive tape (50 ram width "Blenderm") + adhesive bandage (50 mm width "Elastoplast")
- Duration: 48 hours
- Evaluation (hr after challenge): directly after removal of patchB.
CHALLENGE EXPOSURE (all animals)
- Frequency of exposure: once
- Time schedule: 2 weeks after termination of induction exposures
- Site: left flank
- Area of application: 2 x 2 cm (Whatman No. 3 paper)
- Concentrations: undiluted (anterior flank) and 50% (v/v) in vehicle- Volume applied: 0.2 ml/animal
- Type of coverage: occlusive (impemeable plastic adhesive tape (50 ram width "Blenderm") + adhesive bandage (50 mm width "Elastoplast")
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
SCORING SYSTEM:
OECD Draize system
Erythema and eschar formation:
No erythema 0
Slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Slight oedema 1
Well-defined (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
OTHER
All animals were observed daily for signs of ill health or toxicity. The body weight of each guinea-pig on the main study was recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge applications. - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (CAS No. 101-86-0)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Refer to Table 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Refer to Table 2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Refer to Table 2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Refer to Table 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Refer to Table 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Refer to Table 2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Refer to Table 2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Refer to Table 2
- Group:
- positive control
- Remarks on result:
- other: see Table 1
Any other information on results incl. tables
Table 1:
M&K R&D No. |
Number of animals |
Dates of study |
Dates of receipt of HCA |
Dose levels % (aqueous dilutions) |
Results |
||||||
Induction |
Challenge |
||||||||||
Test |
Control |
Start |
Finish |
Intradermal |
Topical |
Positive |
Inconclusive |
Negative |
|||
1 |
10 |
5 |
08.12.92 |
09.01.93 |
29.10.92 |
10 |
As Supplied |
As supplied and 50 |
10/10 |
0/10 |
0/10 |
IE |
10 |
10 |
20.07.93 |
16.08.93 |
11.06.93 |
10 |
As Supplied |
As supplied and 50 |
9/10 |
0/10 |
1/10 |
2A |
10 |
10 |
15.03.94 |
11.04.94 |
11.06.93 |
10 |
As Supplied |
As supplied and 50 |
10/10 |
0/10 |
0/10 |
2D |
10 |
10 |
06.09.94 |
01.10.94 |
12.08.94 |
10 |
As Supplied |
As supplied and 50 |
9/10 |
0/10 |
1/10 |
2G* |
10 |
10 |
28.09.94 |
23.10.94 |
12.08.94 |
10 |
As Supplied |
As supplied and 50 |
10/10 |
0/10 |
0/10 |
2H |
10 |
10 |
05.10.94 |
30.10.94 |
12.08.94 |
10 |
As Supplied |
As supplied and 50 |
10/10 |
0/10 |
0/10 |
3A |
10 |
10 |
24.01.95 |
18.02.95 |
24.10.94 |
10 |
As Supplied |
As supplied and 50 |
8/10 |
1/10 |
1/10 |
Animals supplied by D. Hall Newchurch.
* Animals supplied by Interfauna (UK) Ltd.
Hexyl cinnamic aldehyde obtained from Aldrich Chemicals Co.
Table 2. Dermal reactions observed after each induction
Site |
Intradermal injection |
Topical application |
||
Test animals |
Control animals |
Test animals |
Control animals |
|
1 |
Necrosis |
Necrosis |
Slight erythema |
Slight erythema |
2 |
Slight irritation |
Slight irritation |
||
3 |
Necrosis |
Necrosis |
||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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