Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Reliability changed from "1" to "2" according to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Historical in vivo data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): confidential
- Substance type: surfactant
- Physical state: colourless liquid
- Analytical purity: 30 %
- Composition of test material, percentage of components: CAS 683-10-3 (22 %) + 2601-33-4 (8 %); 39.7% solid content, 6.5 % potassium salt
- Purity test date: 23 March 2006
- Lot/batch No.: BK060202
- Expiration date of the lot/batch: 10 February 2008
- Stability under test conditions: all dosage form preparations were made freshly on the morning of administration, any unused material was discarded that same day
- Storage condition of test material: at room temperature
- Other: Source: supplied by sponsor

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France
- Age at study initiation: 1 - 2 months old
- Weight at study initiation: males 332 - 401 g; females 335 - 396 g
- Housing: individually
- Diet (e.g. ad libitum): 106 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Millipore-filtered (0.22 micron) drinking water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Results and discussion

Positive control results:
The sensitivity of the experimental technique is regularly assessed using a known moderate sensitizer. In a recent study performed under the experimental conditions of the testing laboratory, the strain of guinea pigs used showed a satisfactory sensitisation response in 100 % of the animals.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
discrete erythema (grade 1), dryness of the skin in one animal
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1), dryness of the skin in one animal.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
moderate erythema (grade 2), dryness of the skin in both animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: moderate erythema (grade 2), dryness of the skin in both animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
discrete erythema (grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: discrete erythema (grade 1).
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
discrete erythema (grade 1), dryness of the skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: discrete erythema (grade 1), dryness of the skin.

Any other information on results incl. tables

In the control group, a discrete erythema was observed on the right flank (test item application) of 3/10 animals at the 24-hour reading and persisted in one of them, associated with a dryness of the skin, at the 48-hour reading.

In the treated group, on the right flank, a discrete erythema (grade 1) was noted in 5/20 animals at the 24-hour reading; at the 48-hour reading, a moderate erythema (grade 2) was observed in 2/20 animals. A dryness of the skin was also noted in 1/20 and 2/20 animals at the 24- and 48-hour readings, respectively.

Conclusion:

The higher number of animals demonstrating cutaneous reactions (5/20, corresponding to 25 %) in the 24-hour reading have to be ascribed to the irritant character of the test substance and must be considered as local irritation reaction. Even this number does not exceed the threshold of 30% positive reactions, demanded by the underlying OECD guideline for sensitisation tests with adjuvant, required to consider a test substance as sensitising.

After 48 hours, only 2/20 animals (10%) with cutaneous reactions remain, which have to be considered as sensitised.

Under the experimental conditions chosen, using the maximisation method of Magnusson and Kligman, the test item finally induced cutaneous reactions in 2/20 (10%) guinea pigs. According to the criteria of Council Directive 67/548/EEC (DSD) and the CLP regulation the test item does not need to be classified as sensitising to the skin.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information