Registration Dossier
Registration Dossier
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EC number: 907-241-9 | 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:
- 17.08.1995 to 26.01.1996
- 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:
- 1996
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
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The described guinea pig sensitisation test (Buehler test) according to OECD 406 was conducted in 1996 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the Buehler test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Test material
- Reference substance name:
- 1-chlorododecane
- EC Number:
- 203-981-5
- EC Name:
- 1-chlorododecane
- Cas Number:
- 112-52-7
- Molecular formula:
- C12H25Cl
- IUPAC Name:
- 1-chlorododecane
- Details on test material:
- n-Lauryl chloride; 1-Chlorodecan, CAS-No. 112-52-7
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White Hsd/Win:DH [SPF]
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species: Guinea pig, Dunkin Hartley, Pirbright White Hsd/Win:DH [SPF]
- Source: Harlan Winkelmann, Versuchstierzucht GmbH & Co KG, Borchen, Germany
- Sex: female
- Age at study initiation: young adult animals
- Mean weight at study initiation: below 500 g
- Housing: max. 5 animals/cage (Macrolon type IV)
- Diet: Ssniff G 4 Alleindiaet fuer Meerschweinchen (Fa. Ssniff, Spezialfutter GmbH, Soest, Germany)
- Water: tap water; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Remarks:
- MEH 56
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 7
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Remarks:
- MEH 56
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 14
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Remarks:
- MEH 56
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 6 hours
- No. of animals per dose:
- 20
- Details on study design:
- The maximum non-irritant concentration was determined in a pre-test. Induction concentration (day 0): 100 % n-Lauryl chloride. Induction concentration (day 7 and 14): 50 % n-Lauryl chloride in corn oil. Challenge concentration, dermal: 25 % n-Lauryl chloride in corn oil. Applications: 6 hours occlusive.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
0/20 test animals and 0/10 controls showed skin reactions 30
h or 54 h after the challenge application.
After the first dermal induction irritation was observed in
18 of 20 test animals (slight to moderate erythema and
oedema). Therefore the concentration was lowered to 50% for
the two following inductions.
After the second induction slight skin reactions were
observed in 4 test animals. After the third induction 9 test
animals showed clear Erythema, 4 Oedema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Buehler guinea pig test for skin sensitization no animal in the control and test groups showed any sign for skin sensitization. Thus, the available data on skin sensitization of lauryl chloride do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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