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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with internationally recognised test guidelines. For read across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
considering the historical data present in the laboratory database, the false positive results indicated the possibility to use a non LLNA method, for this kind of chemical. In order to have a correct response a non LLNA study was carried out for the test item.

Test material

Constituent 1
Reference substance name:
Rape oil, sulfated, sodium salt
EC Number:
281-978-8
EC Name:
Rape oil, sulfated, sodium salt
Cas Number:
84082-30-4
Molecular formula:
not available (substance is a UVCB)
IUPAC Name:
Not applicable
Details on test material:
- Name of test material : CS03
- Physical state: Liquid
- Lot/batch No.: 0008
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 382-487 g
- Housing: Up to 5 animals/cage noryl cages measuring 74.3 x 54.3 x 25 cm
- Diet (e.g. ad libitum): 8GP17 (Mucedola Srl) diet available ad libitum
- Water (e.g. ad libitum): tap water available ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2012-08-27 To: 2012-10-06

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 %
No. of animals per dose:
test group: 20 animals
control group: 10 animals
Details on study design:
RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in water at various concentrations were injected intracutaneously into the skin of the scapula region. 24 hours and 7 days after application skin reaction was assessed.
For dermal applications various concentrations of the substance in water were applied on patches of 2x2 cm to the clipped skin. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle at 0.5% concentration and in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 5 % test substance in water (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: dermal treatment
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 1 %
- Evaluation: 24 and 48 hours after removal of dressings
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Delayed dermal sensitisation has been investigated using the maximisaton test according to OECD/EU test guidelines. The substance did not induce delayed dermal sensitisation in the guinea pig.
Executive summary:

Delayed dermal sensitisation has been investigated using the maximisaton test according to OECD/EU test guidelines. The substance did not induce delayed dermal sensitisation in the guinea pig.