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Toxicological information

Skin sensitisation

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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:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
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 Calcium sulfonate, 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.