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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2 April - 10 May 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline, non-GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Age at study initiation:no data
- Weight at study initiation: 225-325 g
- Housing: singly in wire mesh suspensioncages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr): 12 h/12 h
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
No. of animals per dose:
10 male/10 female
Details on study design:
RANGE FINDING TESTS:
Test substance applied at 100 %, 50 %, 25 %, 10 %, 5 %, 2.5 % or 1 % w/v in distilled water. 4 concentrations/ guinea pig. 0.3 mL/patch. Occluded conditions. Based on the results, a concentration of 25 %w/v was chosen for induction and 5 %w/v for primary challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.3 mL of 25 %w/v solution
- Control group: none
- Site: upper left quadrant of backs
- Frequency of applications: weekly
- Duration: 6 hours under occlusive conditions
- Concentrations: 25 %w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:2 weeks after last induction
- Exposure period: 6 hours
- Test groups: 0.3 mL of 5 %w/v solution
- Control group: 0.3 mL of 5 %w/v solution
- Site: lower left quadrant of backs
- Concentrations: 5 %w/v solution
- Evaluation (hr after challenge): 24 & 48 h

OTHER:
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean severity of skin scores = 0.0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean severity of skin scores = 0.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 %wv/v
No. with + reactions:
1
Total no. in group:
19
Clinical observations:
Mean severity of skin scores = 0.03
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %wv/v. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: Mean severity of skin scores = 0.03.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %w/v
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
Mean severity of skin scores= 0.2
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %w/v. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Mean severity of skin scores= 0.2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 %w/v
No. with + reactions:
5
Total no. in group:
19
Clinical observations:
Mean severity of skin scores = 0.1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %w/v. No with. + reactions: 5.0. Total no. in groups: 19.0. Clinical observations: Mean severity of skin scores = 0.1.

One animal in the test group was found dead after the third induction. Necrospy showed lungs pale, liver pale, abdominal cavity filled witha red blood-like material and slight post mortem autolysis.

The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group, indicating that sensitisation had not been induced.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a Buehler test performed using a method similar to OECD TG 406, C8 alkane sulfonate was found to be non-sensitising to the skin of guinea pigs.The incidence(1/19 and 5/19 positive reactions at 24 and 48 hours after challenge, compared to 0/10 and 3/10 for the negative controls)and severity of the responses in the test group was essentially comparable to that produced by the negative control group, indicating that sensitisation had not been induced. This result is read across to the substance as C8 alkane sulfonate is the main constituent and has the same structure as the other main constituent, C6 alkane sulfonate.


Migrated from Short description of key information:
The substance is not a skin sensitiser in guinea pigs based on a study performed with C8 alkane sulfonate.

Justification for selection of skin sensitisation endpoint:
One study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance is not sensitising, based on read across to data on the main constituent, which has the same structure as the other main constituent of the substance. Classification is not required.