[No public or meaningful name is available]

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP standards

Type of study:

other: local lymph node assay

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): c-4000
- Physical state: liquid
- Analytical purity: >99%
- Purity test date: 2007-02-26
- Lot/batch No.: jyc0367
- Expiration date of the lot/batch: 2007-08-26
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: acetone/castor oil 4:1

Concentration:

25% v/v test material in vehicle
50% v/v test material in vehicle
100% v/v test material in vehicle

No. of animals per dose:

5 animals received the vehicle
5 animals received a 25% v/v test material in vehicle
5 animals received a 50% v/v test material in vehicle
5 animals received a 100% v/v test material in vehicle

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: A stimulation index of less than 3 (1.61 to 1.84) was recorded for the undiluted test material and test material diluted at 50 and 25% in vehicle.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Mean DPM reachs 2925 at the 50% dosage , compared to 1187 for control.

Any other information on results incl. tables

Table #: Results of LLNA: Mean Disintegrations per minute and stimulation index per group

 

Sample Description Test or Control Group	Animal #	Individual Animal DPM ^a	Group Mean DPM +/- SE	Stimulation Index (SI)*
Vehicle	1		1187.78 +/- 494.23	N\A
	2
	3
	4
	5
25%	1		1911.89 +/- 1911.89	1.61
	2
	3
	4
	5
50%	1		2925.62 +/- 814.72	2.46
	2
	3
	4
	5
100%	1		2187.72 +/- 711.64	1.84
	2
	3
	4
	5

a) Pooled animal data is also acceptable (minimum of 4 animals/group)

* SI = Group mean DPM )Vehicle control mean DPM

 

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

C-4000 is not a sensitizer and is not classified

Executive summary:

In a dermal sensitization study with c-4000 (>99% a.i.) in acetone/olive oil 4:, BCBA/CA strain mouse females were tested using the method of the local lymph node assay. Positive control material is alpha-hexylcinnamaldehyde.Any signs of toxicity or sign of ill or bodyweight change was recorded during the test. 

 

In this study, C-4000 is not a dermal sensitizer.