Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-10-20 to 1999-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a. OECD guideline 406 followed under GLP procedures

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- supplier: Elf Atochem SA on 1998-08-12
- Physical state: white powder
- Analytical purity: 92.7%
- Impurities (identity and concentrations):
- iron content 1ppm
- calcium content 48 ppm
- Purity test date: 1998-08-05
- Lot/batch No.: 980303137
- Elf Atochem filling nimber: CAL 1044/98
- Expiration date of the batch: august 1999

- Stability under test conditions: no data
- Storage condition of test material: at room temperature and protected from light and humidity

PREPARATION
test substance was finely pulverised before being incorporated in the vehicle. all preparation were freshly made on the morning of the administration.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles Rives France, Saint-Aubain-lés-Elbeuf, France
- Age at study initiation: 3 months old
- Weight at study initiation: 337 +- 16 g for males and 339 +- 12 g for females
- Housing: individually in cages (48cmx27cmx20cm). Dust free sawdust were followed with bacteriological and chemical analysis including the detection of possible heavy metals or pesticides
- Diet: free access to 106 pelletted diet. food is regularly analysed by the supplier (UAR, Villemoisson-sur-Orge, France) for their composition and contaminant content
- Water ad libitum. water filtered (FG millipore membrane 0.22µm). Food and Water are regularly analysed forbacteriological and chemical content including pesticides and heavy metals.
No contaminants were known to have been present in the diet, drinking water or bedding material.
- Acclimation period: at least 5 days before the beginning experiment
- sex:
- preliminary test one male and one female
- definitive test: 15 males and 15 females within 5 of each as control
- all females were nulliparous ans non-pregnant
- identification of animals with ear-tattoo

ENVIRONMENTAL CONDITIONS
- Temperature: 21+- 2°C
- Relative Humidity: 30 to 70%
- Air changes 12 cycles per hr
- Photoperiod: 12hrs dark / 12hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
concentration for induction exposure :
- intradermal injection at 0.1% (w/w)
- topical application at 40 % (w/w)
concentration for challenge exposure:
- topical application at 40% (w/w)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
concentration for induction exposure :
- intradermal injection at 0.1% (w/w)
- topical application at 40 % (w/w)
concentration for challenge exposure:
- topical application at 40% (w/w)
No. of animals per dose:
control group 1: 5males + 5 females
treated group 2: 10 males + 10 females
Details on study design:
RANGE FINDING TESTS: preliminary test was conducted one male and one female
A/ induction exposure:
-one intradermal injection at 0.1% was tested. It was well tolerated systematically and locally
-cutaneous route: several concentrations were tested at 40 and 20% (w/w) and scoring after 24h and 48h after removal of the dressing. Both concentration were well tolerated systematically and locally by male and female animal. The highest concentration was retained for the two topical application on day 8 and 22 of the definitive test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: intradermal route on day 1 (3 injections of 0.1mL as prescribed in the OECD guideline and cutaneous route on day 8 after induction of local irritation as prescribed in the OECD guideline
- Test groups: 11 aminoundecanoic acid in FCA
- Control group: FCA only
- Site: interscapular area
- Duration: day 0 to 8 then day 8 to 22
- Concentrations: intradermal injection 0.1 % (w/w) and cutaneous application 40% (w/w)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24h
- Test groups: 11 aminoundecanoic acid
- Control group: 11 aminoundecanoic acid
- Site: posterior right flank (left flank -vehicule control-)
- Concentrations: 40% (w/w)
- Evaluation: 24 and 48h after challenge

OTHER:
Challenge controls:
no challenge control
Positive control substance(s):
yes
Remarks:
2,4-Dinitro Chlorobenzene (DNCB)

Results and discussion

Positive control results:
During the induction period the reference substance DNCB was applied at the concentration of 0.1% (w/w) (day 1) and 1% (w/w) (day 8) in corn oil. For the challenge application, DNCB was applied at the concentration of 1% (w/w) in corn oil.
The species and strain used for positive control showed satisfactory sensitization response in 90% animals treated with DNCB

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

no clinical signs nor mortality were observed during the study

the body weight gain of the treated animals were normal compared to the body weight gain for control animals

No cutaneous reactions were observed.

All scoring of skin reaction were negative for erythema and oedema for all animals in each group (treated and control).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to the maximization method of Magnusson and Kligman, the test substance UNDECANOIC ACID, 11-AMINO does not induce delayed contact hypersensitivity in guinea-pigs. Classification: not sensitizing according to EU and GHS classification.
Executive summary:

In a skin sensitization test (CIT, 1999), the potential of 11 aminoundecanoic acid (batch No. 980303137) to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman OECD 406. Thirty animals were allocated to 2 groups: a control group 1 (5 males+ 5 females) and a treated group 2 (10 males+10 females). Skin reactions were evaluated approximatively 24 and 48h after removal of the dressing. At the end of the study animals were killed without examination of internal organs and no skin samples were taken.

No clinical signs and no deaths were observed during the study. The body weight gain of the treated animals was normal when compared to that of the control animals. On day 10, after the cutaneous application of the induction period, signs of irritation were observed at the interscapular test site in the control and treated groups. After challenge application, no cutaneous reactions were observed. Under the tested condition and according to the maximization method of Magnusson and Kligman, the test substance 11 aminoundecanoic acid does not induce delayed contact hypersensitivity in guinea-pigs.