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EC number: 443-950-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March 2002 to 02 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): NALCO 01WC026 / PSO
- Lot/batch No.:XC1M0642
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland.Kisslegg, Germany
- Age at study initiation: approx 5 weeks
- Weight at study initiation: 328 - 429 g
- Housing: Group housing, maximum of 5/ metal cage with wire-mesh floors.
- Diet (e.g. ad libitum): Free accesss to standard guinea pig diet, including ascorbic acid (1000mg/kg) (Charles River Breeding And Maintenance Diet For Guinea Pigs, Altromin, Lage, Germany)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: At least 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx 15 / hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- Milli-U
- Concentration / amount:
- Main study:
Induction phase: intradermal injection, 20% (w/w) in Milli-U water
topical application, 100%.
Challenge phase: topical application, 100%
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Remarks:
- Milli-U
- Concentration / amount:
- Main study:
Induction phase: intradermal injection, 20% (w/w) in Milli-U water
topical application, 100%.
Challenge phase: topical application, 100%
- No. of animals per dose:
- 10 animals in test group
5 animals in control group - Details on study design:
- PRELIMINARY IRRITATION STUDY:
A serries of four test substance concentrations were used of the intradermal injections and the epidermal application, 10, 20, 50 and 100%..
Intradermal injection
Each of two animals received two different concentrations in duplicate (0.1ml/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
Epidermal application
Two different concentrations were applied (0.5ml) per animal to the clipped flank, using Metalline patches (2 x 3 cm) mounted on medical tape which were held inplace with Miropore tape and subsequently Coban elastic bandage. Animals which had received intradermal injections were treated with the lowest concentrations 10 and 20% and a further two animals (not previously treated) with the highest concentrations 50 and 100%. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
Dose levels were selected based on the results of the preliminary irritation study
A. INDUCTION EXPOSURE - treated animals
Intradermal induction
Day 1; The scapular region was clipped and three pairs of intradermal injections (0.1ml/site) were made as follows:
A) A 1:1 w/w mixture of Freunds' Complete Adjuvant with water
B) The test substance at 20%
C) A 1:1 w/w mixture of the test substance at twice the concentration used in (B) and Freunds' Complete Adjuvant
On Day 3 the dermal reactions caused by the intradermal injections were assessed for irritation
Topical induction
On the day prior to topical induction (day 7), the scapular area between the injection sites was clipped and subsequently rubbed with 10% w/w sodium lauryl sulfate (SDS) in vaseline using a spatula. On study day 8, the 10% SDS treated area between the injection sites was treated with 0.5 ml of a 100% test substance concentration using a Metaline patch (2 x 3 cm) mounted on medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance using water and the dermal reactions caused by the epidermal exposure assessed for irritation.
Induction - Control animals
The control animals were subject to the same procedure as the treated animals except that, instead of test substance, vehicle alone was administered:
B. CHALLENGE EXPOSURE - all animals
Day 21 One flank of all animals was clipped and treated by epidermal application of a 100% test substance concentration and the vehicle (0.1ml) each, using Patch Test Plasters. The patches were held in place with Micropore tape and subsequently Coban elastic bandage
The dressing was removed after 24 hours exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 hours after removel of the dressing.. - Challenge controls:
- Intradermal induction
Day 1; The scapular region was clipped and three pairs of intradermal injections (0.1ml/site) were made as follows:
A) A 1;1 w/w mixture of Freunds' Complete Adjuvant with water
B) Milli-U water
C) A 1:1 w/w mixture of Milli-U water and Freunds' Complete Adjuvant
On Day 3 the dermal reactions caused by the intradermal injections were assessed for irritation
Topical induction
On the day prior to topical induction (day 7), the scapular area between the injection sites was clipped and subsequently rubbed with 10% w/w sodium lauryl sulfate (SDS) in vaseline using a spatula. On study day 8, the 10% SDS treated area between the injection sites was treated with 0.5 ml of Milli-U water using a Metaline patch (2 x 3 cm) mounted on medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned using water and the dermal reactions caused by the epidermal exposure assessed for irritation.
Challenge exposure
Day 21 One flank of all animals was clipped and treated by epidermal application of a 100% test substance concentration and the vehicle (0.1ml) each, using Patch Test Plasters. The patches were held in place with Micropore tape and subsequently Coban elastic bandage
The dressing was removed after 24 hours exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 hours after removel of the dressing.. - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamic aldehyde, tech 85%
Results and discussion
- Positive control results:
- Alpha-hexylcinnamic aldehyde, tech 85%
Intradermal induction at 20.0% w/W alpha-Hexylcinnamaldehyde in Milli-U water followed by topical induction with undilited material and challenge at levels of 20% w/w alpha-Hexylcinnamaldehyde in Milli-U water, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent
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:
- No toxic symptoms
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No toxic symptoms
- 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: 10.0. Clinical observations: No toxic symptoms.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No toxic symptoms
- 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: 5.0. Clinical observations: No toxic symptoms.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No toxic symptoms
- 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: 5.0. Clinical observations: No toxic symptoms.
Any other information on results incl. tables
Please refer to attached file S7.4.1 Skin Sensitisation results tables 1 - 4.pdf for the table identified below.
PRELIMINARY IRRITATION STUDY
The results for the intradermal injections and epidermal exposures for the selection of suitable dose levels for the main study are given in Table 1 (See attached file S7.4.1 Skin Sensitisation results tables 1 - 4.pdf)
No signs of irritation were observed to the highest test substance concentration epidermally tested. Based on the results, the test substance concemtration selected for the main study were a 20% concentration for the intradaermal induction and a 100% concemtration for the epidermal induction. A 100% test substance concentration was selected for the challenge phase.
MAIN STUDY
Induction Phase
The skin effects caused by intradermal injections and epidermal exposure are given in Table 2 (See attached file S7.4.1 Skin Sensitisation results tables 1 - 4.pdf)
The reactions noted in the control animals after epidermal induction exposure were enhanced by sodium dodecyl sulphate.
Challenge phase
No skin reactions were evident after the challenge exposure in the experimental or control animals. (Table 3 attached file S7.4.1 Skin Sensitisation results tables 1 - 4.pdf)
Mortality - There were no deaths
Clinical signs - There were no symptoms of systemic toxicity
Bodyweight - Bodyweights and bodyweight gain of experimental animals were in the same range as the controls. (Table 4 attached file S7.4.1 Skin Sensitisation results tables 1 - 4.pdf)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- There was no evidence that the test substance had caused skin hypersensitivity, since no responses were observed in the experimental animals in the challenge phase. The result indicates a sensitisation rate of 0%, based on these results the test substance should be classified as a non-sensitiser.
- Executive summary:
The contact hypersensitivity of the test substance was determined based on the EEC Directive 96/54/EC, B.6, "Skin Sensitisation", OECD Guideline no. 406 "Skin Sensitisation" and OECD OPTTS 870.2600 "Skin Sensitisation".
Ten female Dunkin-Hartley guinesa pigs were intradermally injected with a 20% concentration of the test substance and epidermally exposed to a 100% concentration (induction phase). Five control animals were simmialrly treated, but with vehicle (water alone). Approximatley 24 hours before the epidermal induction exposure, all animals were treated with 10% sodium dodecyl sulphate. Two weeks after the epidermal application all animals were challenged with a 100% test substance concentration and the vehicle.
No skin reactions were evident after the challnege exposure in the experimental animals and the control animals. Based on these results the test substance should be classified as a non-sensitiser
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