Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

Constituent 1
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.