Undecenal

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from publication

Data source

Reference

Reference Type:

publication

Title:

Compilation of Historical Local Lymph Node Data for evaluation of skin sensitization Alternative Methos

Author:

G. Frank Gerberick, Cindy A. Ryan, Petra S. Kern, Harald Schlatter, Rebecca J. Dearman, Ian Kimber, Grace Y. Patlewicz, and David A. Basketter

Year:

2005

Bibliographic source:

Dermatitis, Vol 16, No. 4 (December), 2005: pp 157-202

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Principles of method if other than guideline:

In vivo skin sanitization toxicity study of trans -2-Decenal in female mice

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

2-decenal

EC Number:

223-472-1

EC Name:

2-decenal

Cas Number:

3913-71-1

IUPAC Name:

dec-2-enal

Constituent 2

Reference substance name:

trans -2-Decenal

IUPAC Name:

trans -2-Decenal

Details on test material:

- Name of test material (as cited in study report): trans -2-Decenal
- Molecular formula (if other than submission substance): C10H18O
- Molecular weight (if other than submission substance): 154.2512 g/mole
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: No data available
- Age at study initiation: 7-12 weeks
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To No data available

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25 μl

No. of animals per dose:

No data available

Details on study design:

RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 day
- Test groups: 1
- Control group: 1
- Site: Dorsum of Both ears
- Frequency of applications: Once daily
- Duration: 3 day
- Concentrations: 25 μl

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Five days
- Exposure period: Once
- Test groups: 1
- Control group: 1
- Site: Tail
- Concentrations: 250 μL
- Evaluation (hr after challenge): 5 hours

OTHER: No data available

Positive control substance(s):

other: Phosphate-buffered saline

Statistics:

A substance was classified as a skin sensitizer if, at one or more test concentration, it induced a threefold or greater increase in local lymph node proliferative activity when compared with concurrent vehicle – treated control (SI, ≥ 3).

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

other: Migrated information from in vivo LLNA study

Remarks on result:

other: Reading: other: calculated. Group: test group. Dose level: 25 μl . Clinical observations: Moderate sensitizer .

Results 2

Parameter:

SI

Remarks on result:

other: 9.5

Any other information on results incl. tables

Chemical structure, Physicochemical Parameters, LLNA data, and Potency Categorization

Chemical structure,	CAS no.	Log KP	Log kow	MW	Vehicle	LLNA %	LLNA%	LLNA%	LLNA%	LLNA%	LLNA%	LLNA SI	LLNA SI	LLNA SI	LLNA SI	LLNA SI	LLNA SI	LLNA SI	LLNA EC3*(%)
	3913-71-1	-1.86	2.54	154.25	AOO	0.5	1.0	2.5	5.0	10.0	-	1.3	1.1	3	6	9.5	-	2.5	Moderate

AOO = acetone olive oil (4:1); CAS = Chemical Abstrac service number; Kow = octenol water partition coefficient (log scale); Kp=skin penetration coefficient (log scale); LLNA= local lymph node assay

*Mathematically estimated concentration of test chemical necessary to induce a threefold stimulation index (SI)

Classification of relative skin sensitization potency by Local Lymph Node Assay EC3 values

EC3 values (%)	Potency Classification
≥ 10 to ≤ 100	Weak
≥ 1 to ≤ 10	Moderate
≥ 0.1 to ≤ 1	Strong
< 0.1	Extreme

 

Log kow (Log P) Distribution of Allergens by Potency Classification

Log kow rang	Skin penetration	Allergen Potency* Distribution
< - 3	Very poor skin permeant, very hydrophobic	0
≥- 3 to -1	Poor skin permeant, hydrophobic	4 (2E, 1S, 0M, 1W)
≥- 1 to 3	Very good skin permeant, amphiphilic	113 (7E, 17S, 54M, 35W)
≥ 3 to 5	Good skin permeant, slightly lipophilic	43 (2E, 3S, 11M, 27W)
≥ 5	Moderate skin permeant but decreasing with increasing log kow	9 (2E, 0S, 4M, 3W)

 

Molecular weight Distribution of Allergen Potency

MW rang	Allergen Potency* Distribution
< 100	10 (0E, 2S, £M, %W)
≥100 to 200	89 (5E, 11S, 45M, 28W)
≥ 200 to 300	45 (7E, 4S, 12M, 22W)
≥ 300 to 400	23 (1E, 3S, 8M, 11W)
≥ 400	2 (0E, 1S, 1M, 3W)

 MW= molecular weight

*Designated as E (extreme), S (strong), M (moderate), W (weak)

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

trans -2-Decenal was found to be moderate sensitizer to CBA female mice when threefold stimulation index (SI) of trans -2-Decenal was mathematically estimated.

Executive summary:

trans-2-Decenal was found to be moderate sensitizer to CBA female mice when threefold stimulation index (SI) of trans-2-Decenal was mathematically estimated.

 

Hence, trans-2-Decenal was classified as moderate sensitizer