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Skin sensitisation

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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:
1996
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

Constituent 1
Chemical structure
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

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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