2-bromoethylammonium bromide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source.

Data source

Reference

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report For SIAM 15, CAS no: 2432-99-7 (11-aminoundecanoic acid)

Author:

OECD SIDS-SIAM 15

Year:

2002

Bibliographic source:

SIDS Initial Assessment Report for SIAM 15, Boston, Massachusetts, 22 - 25 October 2002.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Skin sensitization study of 11-aminoundecanoic acid was performed in guinea pig by Guinea pig maximization test

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

No data available

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

2432-99-7

Molecular formula:

C11H23NO2

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): 11-aminoundecanoic acid
- Molecular formula:C11H23NO2
- Molecular weight:201.307g/mole
- Substance type: organic

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

corn oil

Concentration / amount:

Induction :0.1% (w/w) in corn oil,
Topical application: 40% (w/w) in corn oil

Day(s)/duration:

48hr

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Concentration / amount:

Topical application: 40% (w/w) in corn oil.

Day(s)/duration:

24hr

No. of animals per dose:

Total:30
Test group:5 male and 5 female
Control:10 male and 10 female

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period:48hr
- Test groups:20
- Control group:10
- Site: Interscapular region
- Frequency of applications: on 1st and 8th day
- Duration:8 days
- Concentrations: Induction :0.1% (w/w) in corn oil,
Topical application: 40% (w/w) in corn oil.

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: After rest period of 12 days
- Exposure period:24 hr
- Test groups:20
- Control group:10
- Site: Right flank
- Concentrations: Topical application: 40% (w/w) in corn oil.
- Evaluation (hr after challenge): approximately after 24hr and 48hr

OTHER: On day 1, intradermal injections of Freund's complete adjuvant mixed with
the test substance (treated group) or the vehicle (control group)
On day 7, the same region received a topical application of sodium lauryl
Sulphate in Vaseline (10% w/w) in order to induce local irritation.
The sensitivity of the guinea-pigs in laboratory experimental conditions was
Checked with a positive sensitizer, 2,4-Dinitro Chlorobenzene (DNCB).
During the induction period, the reference substance DNCB was applied at the concentrations of 0.1 % (w/w) (day 1) and I % (w/w) (day 8) in corn oil.
For the challenge application, the reference substance DNCB was applied at the concentration of 1% (w/w) in corn oil.

Challenge controls:

yes

Positive control substance(s):

yes

Remarks:

2,4-Dinitro Chlorobenzene (DNCB)

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

40% w/w in corn oil

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

NO sensitization reaction observed after challenge application, No death of animals was noted. Show In 90% animals treated with DNCB show a satisfactory sensitization response.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: Not skin sensitization .

Conclusions:

The skin sensitization study of11-aminoundecanoic acid (2432-99-7)was performed in guinea pig by guinea pig maximization test . According to the guinea pig maximization method of Magnusson and Kligman, the 11-aminoundecanoic acid (2432-99-7) was considered to be not sensitizing.

Executive summary:

The skin sensitization study of11-aminoundecanoic acid (2432-99-7)was performed by guinea pig maximization method of Magnusson and Kligman using OECD guideline 406 on male and female guinea pig. Group of 30 animals were classified into two groups, test group 10 male and 10 female ,where as in control group 5male and 5 female.The sensitivity of the guinea-pigs in laboratory experimental conditions was checked with a positive sensitizer, 2,4-Dinitro Chlorobenzene (DNCB). During the induction period, the reference substance DNCB was applied at the concentrations of 0.1 % (w/w) (day 1) and I % (w/w) (day 8) in corn oil. For the challenge application, the reference substance DNCB was applied at the concentration of 1% (w/w) in corn oil.

In induction phase,

On day 1, intradermal injections of Freund's complete adjuvant mixed with the test substance (treated group) or the vehicle (control group) were performed in the interscapular region in concentration test substance 0.1% w/w in corn oil.

On day 7, the same region received a topical application of sodium lauryl sulphate in Vaseline (10% w/w) in order to induce local irritation and on next day the test substance in 40% w/w in corn oil was applied to the same test site which was then covered by an occlusive dressing for 48 hours.

In challenge phase,

On day 22, after a rest period of 12 days, all animals of the treated and control groups were challenged by a cutaneous application of the test Substance in concentration 40% w/w in corn oil to the right flank. The left flank served as control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.The all animals were observed for any clinical signs. The species and strain which were used showed a satisfactory Sensitization response in 90% animals treated with DNCB. At the end of the study, animals were killed without examination of internal organs. No skin samples were taken from the challenge application sites. No skin sensitization was observed after the challenge application and no deaths were noted during the study. Hence11-aminoundecanoic acid was considered as not skin sensitizing in guinea pig.