Benzenesulfonic acid, 4-(branched alkyl derivs.) and benzenesulfonic acid, 4-(linear alkyl dervis.), calcium salts

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July and August 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study is similar to early test guidelines in compliance with GLP but without range finding data or concurrent assessment for irritation. As this data is used in a read-across approach Klimisch 2 is assigned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Test material: Total Base Number = 13
Description: Brown/amber oily viscous liquid

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca/Ola/Hsd strain

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Limited, Blackthorne, Bicester, Oxon, UK
- Housing: suspended stainless steel cages (18.4cm x 52.3cm x 12.7cm) with one solid sheet side and mesh front, floor, rear and remaining side
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21±2°C
- Humidity (%): approximately 55±15%
- Air changes (per hr): approximately 25-30 air-changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

0.1, 1, 10 or 30% w/v

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS: none reported
MAIN STUDY
- Test method: Approximately 25 µL of a 0.1, 1, 10 or 30% w/v concentration of the test sample in DMF was applied, using a variable volume micro pipette, to the dorsal surface of each ear, on three consecutive days .
- Criteria used to consider a positive response: one or more concentrations of the test chemical should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

The sensitization potential of hexylcinnamaldehyde was assessed using the method described above. A vehicle control group was similarly treated using acetone.

In vivo (LLNA)

Results

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: The application of test material, at concentrations of 0.1, 1, 10 and 30% w/v in DMF, resulted in an increase in isotope incorporation which was greater than or equal to 3-fold at all four concentrations.

Any other information on results incl. tables

concentration (% w/v)	number of lymphnodes assayed	counts per minute (cpm)	cpm per lymphnode(x102)	test: control ratio
0 (vehicle only) 0.1 1    10 30	8    8   8   8 8	511    1904   1539   5200   10463	0.64    2.38   1.92   6.50   13.08	N/A    3.72   3.00   10.16   20.44

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is considered sensitising to skin

Executive summary:

The substance (Total Base Number = 13) was assessed using the LLNA study method in mice tested at 0.1, 1, 10 and 30% w/v in DMF. All concentrations achieved greater or equal to to 3 -fold increase in isotope incorporation conpared to solvent control and the substance is considered sensitising at all concenrtrations.