Registration Dossier
Registration Dossier
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EC number: 422-030-7 | CAS number: 91538-82-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 24- Feb 17, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was carried out before enforcement of the OECD guideline 429.
Test material
- Reference substance name:
- 1-bromo-4-(trans-4-ethylcyclohexyl)benzene
- EC Number:
- 422-030-7
- EC Name:
- 1-bromo-4-(trans-4-ethylcyclohexyl)benzene
- Cas Number:
- 91538-82-8
- Molecular formula:
- Hill formula: C14H19Br CAS formula: C14H19Br
- IUPAC Name:
- 1-bromo-4-(trans-4-ethylcyclohexyl)benzene
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd.Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: about 5 weeks
- Weight at study initiation: 324 g (range from 300 to 346 g).
- Housing: Two guinea pigs were housed in type GM/5 (EBECO) Makrolon cages with a shelter and placed on mobile racks.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 49 to 61 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12 / 12 h
IN-LIFE DATES: From: day 1 To: day 25
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 1 mL
- Day(s)/duration:
- Day 8/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Number of animals in pre test group: 5 - Details on study design:
- + ++ +++
I . . . . . . . I . . . . . . . . . . . . . l . . I
1 8 22 25 day of experimental part
Induction: stage I + intradermal injection
stage II ++ topical application
Challenge: +++ topical challenge
Induction was performed in two stages. First, the test material was intradermally injected with or without Freund's complete adjuvant on day 1. Then, after one week (day 8), the test material was topically applied under occlusive patch conditions for 48 hours.
The challenge was performed two weeks later by topical application in a non irritating concentration under the same conditions. The patches were then applied for 24 hours on the shaven side of the animals.
Positive control data have been taken from another GLP study T15929. - Positive control substance(s):
- yes
- Remarks:
- 2-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive Reactions:
Vehicle 48h: 0/10
Vehicle 72h: 0/10
Test material 48h: 5/10
Test material 72h: 6/10
Overall:
Vehicle: 0%
Test material: 70%
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 g/L
- No. with + reactions:
- 6
- Total no. in group:
- 10
Any other information on results incl. tables
Findings in the induction phase
After intradermal injection, the common signs of irritation after injection of Freund's complete adjuvant were observed. The injection sites were swollen and red, later, scabs developed.
Findings after challenge
Group |
Induction with |
Challenge with |
Positive animals 48h/72h |
Positive/animals overall |
1 |
Vehicles* |
PEG400 |
0/5 0/5 |
0/5 |
|
|
Test item# |
0/5 0/5 |
0/5 |
2 |
Test item |
Test item |
0/10 0/10 |
0/10 |
|
|
Test item |
0/10 0/10 |
0/10 |
Vehicles *=Liquid paraffin and PEG 400
# = Testing for primary irritation
The challenge was performed on the right side ofthe animals
Group 1: negative control group
After challenge with polyethylene glycol 400, no erythema or edema were observed at the readings. A single treatment was performed with the test item (10 g/L polyethylene glycol 400) to
exclude primary irritation of the test material concentration. No positive reactions were observed in the treated areas at any reading.
Group 2: test material group (details, see Table 4)
After challenge with the test item (10 g/L preparation in polyethylene glycol 400) no positive skin reactions were observed at the readings.This results in 0 % positive reactions after challenge. After challenge, no positive reactions were observed in the areas treated with polyethyleneglycol 400 alone at any reading.
Clinical findings and mortality
The clinical behavior of the guinea-pigs was normal during the study period. All animals survived the study period.
Body weight
The body weight development did not differ from that of the animals of the vehicle group. All animals survived the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not considered to be a sensitizer according to CLP-Regulation (EC) No 1272/2008.
- Executive summary:
Study design
The test material was evaluated for skin sensitizing properties in. the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
5 Female guinea pigs in the negative control group (group 1) treated with the vehicles (liquid paraffin and ethylene glycol 400) and 10 females in the test material group (group 2) were investigated.
Induction included intradermal injection of test material preparation in liquid paraffin (50 g/L with and without Freund's complete adjuvant) on day 1, and topical application of test material preparation in propylene glycol for 48 hours (25 g/L) starting on experimental day 8.
Challenge by topical application of test material preparation in propylene glycol for 24 hours (10 g/L) was performed two weeks after topical induction. Readings were taken at 48 and 72 hours.
Results
Reaction after challenge
Induction with
test materialchallenged with
test materialpositive / total animals
positive / total animals
48 h 72 h overall 50 g/L i.d.; 25 g/L topical 10 g/L 0 / 10 0 / 10 0 / 10
After challenge no positive reactions were observed in the test material treated skin sites.
Conclusions
The test material has not to be classified as a sensitizer according to CLP-Regulation (EC) No 1272/2008.
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