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EC number: 948-091-4 | 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:
- May - June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Already available study
Test material
- Reference substance name:
- Tetradecanol ethoxylated (EO<2.5), reaction products with epichlorohydrin
- IUPAC Name:
- Tetradecanol ethoxylated (EO<2.5), reaction products with epichlorohydrin
- Test material form:
- liquid
- Details on test material:
- Sponsor’s identification : BEROL 1872 (C14 Alkyl polyethoxy glycidylether)
Batch number : 996185
Date received : 15 April 1999
Description : pale yellow slightly turbid liquid
Storage conditions : room temperature in the dark
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: David Hall Ltd., Burton on Trent, UK
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: 317-430 g
- Housing: up to 2 in solid-floor polypropylene cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4 May 1999 To: 14 June 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal Induction : 5% w/v in distilled water
Topical Induction : 25% v/v in distilled water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Topical Challenge : 25% and 10% v/v in distilled water
- No. of animals per dose:
- 10 females in test group; 5 females in control group
- Details on study design:
- RANGE FINDING TESTS:
intradermal induction: (4 additional animals): 1, 5, 10 and 25% w/v (5% w/v was selected)
topical induction: (2 additional animals): 25, 50, 75% v/v and undilited (25% v/v was selected)
topical challenge (2 additional animals): 5, 10, 25, and 50% v/v (10 and 25% v/v were selected)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single intradermal injection (with and without FCA), single epicutaneous application
- Exposure period: day 0 and day 7, respectively
- Test groups: yes
- Control group: no (vehicle only)
- Site: shoulder region
- Frequency of applications: see above
- Duration: single injection and 48-h occlusive epicutaneous application
- Concentrations: 5% w/v and 25%, respectively
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 h (occlusive)
- Test groups: yes
- Control group: yes
- Site: flanks
- Concentrations: 25 and 10% v/v
- Evaluation (hr after challenge): 24 and 48 h after dressing removal
OTHER:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- 2-mercaptobenzothiazole
Induction:
Intradermal: 10% in arachis oil BP
Topical: 50% in acetone:PEG 400 (70:30)
Challenge: 50% and 25% in acetone: PEG 400 (70:30)
Test: females: 10 test animals, 5 control animals
Results: 9/10 positive (90%)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Other skin reactions 24 and/or 48-hour observations included small superficial scattered scabs and desquamation.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Other skin reactions noted at the challenge sites of test group animals at the 24 and/or 48-hour observations included small superficial scattered scabs, desquamation and a hardened dark brown/black-coloured scab.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- One animal showed erythema 1 after 24hr only.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- One animal showed erythema 1 after 24hr only.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: final results
- Group:
- positive control
- Dose level:
- 50% and 25% in acetone: PEG 400 (70:30)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Summary of dermal lesions (following topical challenge) in control and test animals
Animal no. |
Days after challenge application (patch removal) |
Score |
|||||||
1 |
2 |
||||||||
25% v/v |
10% v/v |
25% v/v |
10% v/v |
||||||
Control |
E |
O |
E |
O |
E |
O |
E |
O |
|
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Test |
|
|
|
|
|
|
|
|
|
1 |
2 |
2 |
2 |
2 |
2SsD |
2 |
2SsD |
2 |
+ |
2 |
2 |
1 |
2 |
1 |
2D |
2 |
2D |
2 |
+ |
3 |
2 |
1 |
2 |
1 |
2D |
2 |
2D |
2 |
+ |
4 |
2Ss |
2 |
2Ss |
2 |
2SsD |
2 |
2SsD |
2 |
+ |
5 |
2 |
1 |
2 |
1 |
2D |
2 |
2D |
2 |
+ |
6 |
2 |
1 |
2Ss |
2 |
2SsD |
2 |
2DSt |
2 |
+ |
7 |
2 |
2 |
2 |
1 |
2Ss |
2 |
2 |
2 |
+ |
8 |
2 |
2 |
2 |
1 |
2SsD |
2 |
2D |
2 |
+ |
9 |
2Ss |
2 |
2 |
2 |
2SsD |
2 |
2Ss |
2 |
+ |
10 |
2Ss |
2 |
2 |
1 |
2SsD |
2 |
2 |
2 |
+ |
E= erythema, O= oedema; D= desquamation; Ss = small superficial scattered scabs
St = hardened dark brown/black-coloured scab; + = positive effect;
Discrete or patchy erythema was noted at the challenge sites of one control group animal at the 24-hour observation at both 25% and 10% challenge. No skin reactions were noted at the challenge sites of control group animals at the 48-hour observation.
Summary of dermal lesions (following topical challenge) in control animals
Skin Reactions Observed After Topical Induction
Moderate and confluent to intense erythema with slight oedema was noted at the topical induction sites of all test group animals at the 1-hour observation. A hardened dark brown-coloured or light brown-coloured scab was noted at the topical induction sites of all test group animals at the 24-hour observation and precluded the evaluation of erythema and oedema at this time.
Bleeding from the intradermal induction sites was noted in six test group animals with a bleeding wound, caused by the animal scratching, also noted at the topical induction site of one of these test group animals, at the 1-hour observation.
Discrete or patchy erythema was noted at the topical induction sites of three control group animals at the 1-hour observation and four control group animals at the 24-hour observation.
Bleeding from the intradermal injection sites was noted in four control group animals at the 1-hour observation with dried blood or bleeding from the intradermal injection sites in all control group animals at the 24-hour observation.
Skin Reactions Observed After Topical Challenge
25% v/v in Distilled Water
Positive skin responses (moderate and confluent erythema with very slight to slight oedema) was noted at the challenge sites of all test group animals at the 24—hour observation. Positive skin responses (moderate and confluent erythema with slight oedema) were noted at the challenge sites of all test group animals at the 48-hour observation.
Other skin reactions noted at the challenge sites of test group animals at the 24 and/or 48-hour observations included small superficial scattered scabs and desquamation.
Discrete or patchy erythema was noted at the challenge sites of one control group animal at the 24-hour observation. No skin reactions were noted at the challenge sites of control group animals at the 48-hour observation.
10% v/v in Distilled Water
Positive skin responses (moderate and confluent erythema with very slight to slight oedema) was noted at the challenge sites of all test group animals at the 24—hour observation. Positive skin responses (moderate and confluent erythema with slight oedema) were noted at the challenge sites of all test group animals at the 48-hour observation.
Other skin reactions noted at the challenge sites of test group animals at the 24 and/or 48-hour observations included small superficial scattered scabs, desquamation and a hardened dark brown/black-coloured scab.
Discrete or patchy erythema was noted at the challenge sites of one control group animal at the 24-hour observation. No skin reactions were noted at the challenge sites of control group animals at the 48—hour observation.
Bodyweight
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The (corrected) sensitisation rate was 100% (10/10) under the conditions of this test.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material,C12 Alkyl polyethoxy glycidylether, in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548lEEC). Ten test and five control animals were used for the main study. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction : 5% w/v in distilled water
Topical Induction : 25% v/v in distilled water
Topical Challenge : 25% and 10% v/v in distilled water
The test material produced a 100% (10/10) sensitisation rate.
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