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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and to GLP. however, only half of the recommended number of animals were used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
yes
Remarks:
Only 10 test and 5 control animals were used, instead of 20 test and 10 control animals.
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Cas Number:
70024-69-0
IUPAC Name:
sodium 4-icosylbenzenesulfonate
Details on test material:
the test substance was a similar material to the registered substance (aryl alkyl sulphonate)
- Other: Amber liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley
- Age at study initiation: Young adult
- Weight at study initiation: 300 to 500 g
- Housing: Suspended steel cages
- Diet (e.g. ad libitum): Guinea Pig chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 25 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Mineral oil for rechallenge and second rechallenge
Concentration / amount:
100 % for induction and challenge and 75% in mineral oil for rechallenge and second rechallenge.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Mineral oil for rechallenge and second rechallenge
Concentration / amount:
100 % for induction and challenge and 75% in mineral oil for rechallenge and second rechallenge.
No. of animals per dose:
Topical range finding: 2 males and 2 females
Test: 5 males and 5 females
Challenge control: 5 males and 5 females
Rechallenge control: 5 males and 5 females
Second rechallenge control: 5 males and 5 females
DNCB test: 3 males and 3 females
DNCB: 2 males and 2 females
Details on study design:
RANGE FINDING TESTS: 25, 50, 75 and 100% of the test material was applied to the shaven back of four guinea pigs for 6 hours. test sites were graded for irritation 24 and 48 hours following application.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Control group: DNCB positive control
- Site: right flank
- Frequency of applications: weekly
- Duration: 14 days
- Concentrations: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: day 28, day 35, day 42
- Exposure period: 6 hours
- Control group: DNCB positive control and challenge controls
- Site: right flank
- Concentrations: 100% for 1st challenge, 75% for subsequent challenges
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
5 males and 5 females
Positive control substance(s):
yes
Remarks:
DNCB

Study design: in vivo (LLNA)

Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
Use of statistics not indicated.

Results and discussion

Positive control results:
The positive control substance DNCB behaved appropriately.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
28
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 28.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: DNCB control
No. with + reactions:
2
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: DNCB control. No with. + reactions: 2.0. Total no. in groups: 4.0.
Reading:
1st reading
Hours after challenge:
48
Group:
other: DNBC control
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: DNBC control. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.2%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.2%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
48
Group:
other: DNCB control
No. with + reactions:
1
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: DNCB control. No with. + reactions: 1.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

no further details

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information EU
Conclusions:
Postive reactions in 15% of test animals is required for a positive senisitising result in a non-adjuvant test. Fewer than prescibed test animals were utilised, therfore decreasing the power of the study to detect a sensitiser. 10% of animals displayed a positive result on first challenge, 10-20% of animals displayed a positive reaction on rechallenge, with a lower concentration of test material, and 10-20% of animals displayed reactions on second rechallenge, with a lower concentration of test substance. therefore, according to guidelines, this substance is not a sensitser.
Executive summary:

In a dermal sensitization study with sodium 4-icosylbenzenesulfonate in mineral oil, guinea pigs (5/sex) were tested with a Beuhler test. 

 

  In this study, sodium 4 -icosylbenzenesulfonate is a not dermal sensitizer.