Registration Dossier
Registration Dossier
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EC number: 206-376-4 | CAS number: 334-48-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- nine induction exposures
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males 302 to 396 g; females 303 to 367 g
- Housing: singly in suspended stainless steel cages
- Diet: Charles River Vitamin-C fortified Guinea pig diet, ad libitum
- Water: automatic watering system, ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-75
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- other: 80% ethanol and acetone
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 100% (induction 1-5), 75% (induction 6-9)
- Day(s)/duration:
- 3 exposures per week for a total of 3 weeks
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Challenge: 10%
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Re-challenge: 25%
- Day(s)/duration:
- one week after first challenge
- No. of animals per dose:
- 20 (10 male, 10 females) in the definitive experiment received the test substance
- Details on study design:
- RANGE FINDING TESTS:
- No. of animals: 16
- Vehicle: acetone
- Concentrations: 5, 10, 25, 50, 75, and 100%
- Application of test material: each animal was dosed with two to four different concentrations, at different sites of the clipped dorsal skin.
- Application of test material: 0.2 mL of test material mixture was applied beneath a surgical gauze square, placed directly to the test site. The gauze was covered with plastic sheeting and held in place with an elastic adhesive bandage.
- Evaluation of skin reactions: observation for signs of skin irritation were made approx. 24 and 48 hours after dosing. Evaluation was made according to OECD TG 406, paragraph 23.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 exposures in total; 3 exposures per week
- Exposure period: 3 weeks
- Test groups: 20 animals (10 m, 10 f)
- Control group:
-- Positive control; DCNB; 12 animals (6 m, 6 f)
-- Irritation control (challenge only): nonanoic acid 8 animals; DCNB 8 animals (4m, 4f each)
- Site: dorsal skin, right side of the midline
- Frequency of applications: 3 exposures per week
- Duration: 6 hours each
- Concentrations:
-- nonanoic acid: 100% inductions 1-5; 75% from the 6th induction onwards, due to severe skin irritation
-- DCNB: 0.5 and 0.75% during inductions 1 through 8; ninth induction was omitted due to severe skin irritation
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1
- Exposure period: 6 hours
- Test groups: as described above
- Control group: as described above
- Site: dorsal skin, sites left of the midline
- Concentrations:
-- nonanoic acid: 10% (challenge); 25% (re-challenge, 7 days after first challenge)
-- DCNB: 0.1% at challenge and at re-challenge
- Evaluation (hr after challenge): 24 and 48 after challenge dosing (and after re-challenge dosing)
OTHER: Re-challenge was made 7 days after the challenge treatment - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorbenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 100% and 75%, challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 100% and 75%, challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group, re-challenge
- Dose level:
- induction: 100% and 75%, rechallenge: 25%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- barely perceptible erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group, re-challenge
- Dose level:
- induction: 100% and 75%, rechallenge: 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- barely perceptible erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 0.5 and 0.75%, challenge: 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 0.5 and 0.75%; challenge: 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 20
Any other information on results incl. tables
Nonanoic acid:
0/20 test animals challenged with 10% test substance exhibited any dermal response, 3/20 showed barely perceptible erythema (+/-) after challenge with 25% test substance at 24 h, and 1/20 at 48 h. No irritation responses were noted in the corresponding controls with the 10% and 25% solutions. Scores of +/- are considered equivocal.
Positive
control, DCNB:
9/12
animals challenged with the positive control, 0.1%
2,4-dinitrochlorobenzene, had a score of 1 and greater. No responses
for the irritation controls for this treatment were observed. This
means 9/12 animals showed
positive results (because of a dermal score of 1 or greater, in the
absence of a dermal response in irritation control animals).
Materials |
h |
Erythema evaluation scores |
Total No. of animals |
||||
|
|
0 |
+/- |
1 |
2 |
3 |
|
DCNB, 0.1% |
24 |
2 |
1 |
3 |
6 |
0 |
12 |
|
48 |
2 |
2 |
4 |
4 |
0 |
|
Irritation control |
24 |
8 |
0 |
0 |
0 |
0 |
8 |
|
48 |
8 |
0 |
0 |
0 |
0 |
|
|
|||||||
nonanoic acid, 10% |
24 |
20 |
0 |
0 |
0 |
0 |
20 |
|
48 |
20 |
0 |
0 |
0 |
0 |
|
Re-challenge, 25% |
24 |
17 |
3 |
0 |
0 |
0 |
20 |
|
48 |
19 |
1 |
0 |
0 |
0 |
|
Irritation control |
24 |
8 |
0 |
0 |
0 |
0 |
8 |
|
48 |
8 |
0 |
0 |
0 |
0 |
|
Re-challenge irritation control |
24 |
7 |
1 |
0 |
0 |
0 |
7 |
|
48 |
7 |
1 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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