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EC number: 289-991-0 | CAS number: 90052-75-8
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Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Mar - 24 Apr 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- epicutaneous induction and challenge performed under semi-occlusive conditions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- epicutaneous induction and challenge performed under semi-occlusive conditions
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 416 ± 23 g (mean ± SD, control group); 434 ± 24 g (mean ± SD, treatment group)
- Housing: animals were housed in groups of 5 in labelled metal cages with wire-mesh floors (ITL, Bergen, the Netherlands)
- Diet: standard guinea pig diet (LC 23-B, pellet diameter 4mm, including ascorbic acid (1600 mg/kg); Hope farms, Woerden, the Netherlands), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 March 1998 To: 24 April 1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutaneous, semi-occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: undiluted (intradermal and epicutaneous)
Challenge: undiluted
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: undiluted (intradermal and epicutaneous)
Challenge: undiluted
- No. of animals per dose:
- 10 (treatment group)
5 (control group) - Details on study design:
- RANGE FINDING TESTS:
Prior to the start of the main study, the intradermal and epidermal irritancy of the test substance was investigated to select suitable concentrations for the induction and challenge phase of the main study. The selection was based on the absence of toxicity and on the following criteria for each route and/or study phase:
Induction (intradermal and epidermal): The highest possible concentration that produced moderate irritation (the intradermal reactions may include slight necrosis (< 3 mm in diameter)).
Challenge: The maximum non-irritant concentration.
A series of test substance concentrations were tested. The first and subsequent concentrations were selected from the series: 100% (undiluted), 50%, 20%, 10%, 5%, 2%, 1% and if needed, further lower concentrations using the same steps. The test system and procedures were identical to those used during the main study, unless otherwise specified. The four animals were 5-9 weeks old. The body weights were determined prior to treatment (results not shown).
Intradermal Injections:
A series of four test substance concentrations was used; the highest concentration was the maximum concentration that could technically be
injected (undiluted). One animal received 50 and 100% (undiluted), and the second animal received 10 and 20%, respectively, in duplicate (0.1 mL/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment. Slight erythema was observed at the injection site of the undiluted test substance 48 h after exposure. The udiluted test substance was selected for the induction phase in the main study.
Epidermal application:
A series of four test substance concentrations (10, 20, 50 and 100%) was used. All concentrations could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage (semi-occlusive covering). The animals receiving intradermal injections were treated with the lowest concentrations (10 and 20%) and two further animals with the highest concentrations (50 and 100%). After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure. No skin irritation was observed at any of the treated sites at any of the reading time points. As the epidermal induction using the test substance did not cause any skin irritation, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction. The udiluted test substance was selected for the challenge phase in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intradermal and epicutaneous
- Exposure period: single injection (epidermal) and 48 h (epicutaneous)
- Test groups:
Intradermal, Day 1 (3 pairs of injections, 0.1 mL/site):
Injection 1: a 1:1 mixture (w/w) Freunds Complete Adjuvant (FCA)/water for injection
Injection 2: undiluted test substance
Injection 3: undiluted test substance in a 1:1 mixture (w/w) with FCA (final concentration is 50% test substance)
48 h after intradermal injection (Day 3), the degree of erythema and edema was evaluated.
On Day 7, the scapular area between the injection sites was clipped and subsequently rubbed with 10% sodium dodecyl sulfate in vaseline using a spatula. This concentration of SDS provoked a mild inflammatory reaction.
Epicutaneous, Day 8:
0.5 mL undiluted test substance was applied to the SDS-treated skin area. The semi-occlusive dressing was kept in place for 48 h. The degree of erythema and edema was evaluated directly after cleaning the skin area with water (Day 10).
- Control group:
Intradermal, day 1 (3 pairs of injections, 0.1 mL/site):
Injection 1: a 1:1 mixture (w/w) FCA/water
Injection 2: corn oil
Injection 3: corn oil (w/v) in a 1:1 mixture (w/w) FCA (final concentration is 50% corn oil)
On Day 7, the scapular area between the injection sites was clipped and subsequently rubbed with 10% sodium dodecyl sulfate (SDS, Boom, Meppel, the Netherlands) in vaseline using a spatula. This concentration of SDS provoked a mild inflammatory reaction.
Epicutaneous, Day 8: 0.5 mL corn oil
- Site: the shoulder region
- Frequency of applications: once (intradermal on Day 1 and epicutaneous on Day 8)
- Duration: Day 1 (intradermal), Day 8-10 (epicutaneous)
- Concentrations: undiluted (intradermal and epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL test substance
- Site: approximately 20 mm x 30 mm, on one flank of the animals
- Concentration: undiluted
- Evaluation (hr after challenge): 24 and 48 hours after the challenge ended - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamicaldehyde, tech. 85%
Results and discussion
- Positive control results:
- A reliability check is carried out at regular intervals with alpha-hexylcinnamic aldehyde to check the sensitivity of the test system and the reliability of the experimental methods used by the test laboratory. In an independent study performed in 1998 (report No. 217812), alpha-hexylcinnamic aldehyde induced sensitisation in 80% (8/10) of the Himalayan guinea pigs challenged with a 10% solution, and in 70% (7/10) of the guinea pigs challenged with a 5% solution. A 5% solution was used for intradermal induction and undiluted test substance was used for topical induction.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
48 hours after intradermal induction, slight to severe erythema was noted at all of the sites injected with FCA/water and FCA/test substance in 10/10 treated and 5/5 control animals. 4/5 control animals also exhibited necrosis at the FCA/test substance injection site. In 3/10 treated animals slight to well-defined erythema was observed at the injection site of the test substance. Following the topical induction, severe erythema and scabs were observed at the test site in 3/10 treated animals. A further 4/10 (in total 7/10) treated and 4/5 control animals exhibited only scabs. No edema was observed (see Table 1).
48 and 72 hours after the challenge, no sensitisation was observed in the treated animals.
There was no mortality, no signs of toxicity and no treatment-related effects on body weight.
Table 1: skin irritation effects of intradermal and epidermal induction
Group/ animal No. |
Intradermal induction (Day 3), undiluted test substance |
Epidermal induction (Day 10), undiluted test substance |
|||
Control |
A |
B |
C |
Erythema |
Edema |
16 |
E2 |
NA |
E3 |
0p |
0 |
17 |
E2 |
NA |
N2 |
0a |
0 |
18 |
E3 |
NA |
N3 |
0a |
0 |
19 |
E3 |
NA |
N3 |
0 |
0 |
20 |
E2 |
NA |
N3 |
0a |
0 |
Experimental |
|
|
|
|
|
21 |
E4 |
NA |
E2 |
0a |
0 |
22 |
E1 |
NA |
E1 |
0 |
0 |
23 |
E2 |
E2 |
E2 |
0a |
0 |
24 |
E2 |
NA |
E1 |
0a |
0 |
25 |
E1 |
NA |
E1 |
4k |
0 |
26 |
E1 |
NA |
E1 |
0 |
0 |
27 |
E3 |
E1 |
E2 |
0a |
0 |
28 |
E2 |
E1 |
E2 |
4s |
0 |
29 |
E2 |
NA |
E2 |
4k |
0 |
30 |
E3 |
NA |
E2 |
0 |
0 |
A. 1:1 mixture of FCA and water for injection
B. undiluted test substance (experimental group) or vehicle (control group)
C. 1:1 mixture of FCA and undiluted test substance (experimental group) or vehicle (control group)
a. small scabs
k. scabs
p. scaliness
s. eschar formation
Skin effect intradermal injections:
NA. No abnormalities
E. erythema
N. signs of necrosis (mm in diameter)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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