Registration Dossier
Registration Dossier
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EC number: 500-046-6 | CAS number: 26183-52-8 1 - 2.5 moles ethoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 SEP - 27 OCT 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Alcohols, C12-14, ethoxylated
- EC Number:
- 500-213-3
- EC Name:
- Alcohols, C12-14, ethoxylated
- Cas Number:
- 68439-50-9
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: Dunkin Hartley
- Age at study initiation: 12 weeks
- Weight at study initiation: 329-427g
- Housing: singly or in pairs in solid-floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 1% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Topical Challenge: 50% and 25% v/v in arachis BP
- No. of animals per dose:
- Intradermal Induction: two animals receiving four 0.1 ml injections
Topical Induction: two animals were treated with the undiluted test material and three preparations of the test material
Topical Challenge: two animals per undiluted test material and three preparations of the test material - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: the degree of erythema and oedema was quantified 1 and 24 hours following removal of the patches
- Control group: a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil BP
c) a 50% w7v formulation of arachis oil BP in Freund's Complete adjuvant/distilled water 1:1
- Site: shoulder region
- Duration: 7 days
- Concentrations: 3 injections (0.1 ml each)
a)Freund's Complete adjuvant plus distilled water in the ratio 1:1
b) a 1% w/v formulation of the test material in arachis oil BP
c) a 1% w/v formulation of the test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 21 days
- Site: shorn right flank
- Concentrations: 25% and 50% v/v in arachis oil BP
- Evaluation (hr after challenge): 24 h - Positive control substance(s):
- yes
- Remarks:
- historical data
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
| Animals Number | skin Reactions (Hours After Removal of Dressing) | |||||||||||
| 24 h | 48 h | |||||||||||
| 50% | 25% | 50% | 25% | |||||||||
| Er | Oe | Other | Er | Oe | Other | Er | Oe | Other | Er | Oe | Other | |
| 1 | 0 | 0 | - | 0 | 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 | - |
| 6 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
| 7 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
| 8 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
| 9 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
| 10 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
Er=erythema
Oe=oedema
- = no other reactions noted
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:
- The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required.
- Executive summary:
A study was performed to assess the contact sensitisation potencial of the test material in the albino guinea pig. Ten test and five control animals were used for the main study. Based on the results of sighting test, the concentration of the test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 1% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: 50% and 25% v/v in arachis BP
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required.
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