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EC number: 203-931-2 | CAS number: 112-05-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Pelargonic acid exerted no skin sensitising potential in a valid OECD TG 406 Buehler test using Guinea pigs (KS, RL1). Positive observations made in a murine local lymph node assay with nonanoic acid are concluded to be not indicative for skin sensitising properties, due to the known fact that strong irritants may yield false positive results in this assay. This interpretation as false positive result is supported by mechanistic studies.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- delayed contact hypersensitivity in the guinea pig
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- there is no justification why in the past (1981) the study was performed using Buehler test.
- 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 grams; females 303 to 367 grams
- 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 (°C): 65-75°F
- Photoperiod (hrs dark / hrs light): 12/12 hours
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80 % Ethanol and Acetone (induction); acetone (challenge)
- Concentration / amount:
- Induction: 100%
Challenge: 10%;
Re-challenge: 25% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80 % Ethanol and Acetone (induction); acetone (challenge)
- Concentration / amount:
- Induction: 100%
Challenge: 10%;
Re-challenge: 25% - 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 expoures 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): pelargonic 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:
-- pelargonic 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 above
- Control group: as described above
- Site: dorsal skin, sites left of the midline
- Concentrations:
--pelargonic 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-challnge dosing)
OTHER: Re-challenge was made 7 days after the challenge treatment - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorbenzene
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: irritation controls, DCNB (or pelargonic acid) only
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: irritation controls, DCNB (or pelargonic acid) only. No with. + reactions: 0.0. Total no. in groups: 16.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: irritation controls, DCNB (or pelargonic acid) only
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: irritation controls, DCNB (or pelargonic acid) only. No with. + reactions: 0.0. Total no. in groups: 16.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group, re-challenge
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- barely perceptible erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group, re-challenge. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: barely perceptible erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group, re-challenge
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- barely perceptible erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group, re-challenge. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: barely perceptible erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance exhibited no potential to produce dermal sensitization in a Buehler test using guinea pigs.
- Executive summary:
A dermal sensitisation study was performed according to OECD TG 406 (Buehler) using Hartley guinea pigs. During induction, pelargonoic acid was applied at a concentration of 100% ( at 75% beginning with the 6th treatment due to severe dermal irritation) to a surgical gauze which was directly placed onto the dorsal skin under occlusive conditions for 6 hours. 9 induction treatments were performed within 3 weeks. No dermal sensitisation reaction was seen at 24 and 48 hours after a challenge (patch technique; 14 days after the last induction insult; concentration 10%). Following a re-challenge (patch technique; 7 days after the first challenge; concentration 25%), 3 out of 20 animals exhibited barely perceptible erythema after 24 and 48 h, which were stated to be ambiguous concerning the sensitisation potential of the test substance. Hence the test item elicited no skin sensitisation potential.
Reference
Pelargonic 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 |
Hr |
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 |
|
|
|||||||
Pelargonicacid10% |
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 irritationcontrol |
24 |
7 |
1 |
0 |
0 |
0 |
7 |
|
48 |
7 |
1 |
0 |
0 |
0 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A dermal sensitisation study was performed according to OECD TG 406 (Buehler) using Hartley guinea pigs. During induction, nonanoic acid (NA) was applied at a concentration of 100% (at 75% beginning with the 6th treatment due to severe dermal irritation) to a surgical gauze which was directly placed onto the dorsal skin under occlusive conditions for 6 hours. 9 induction treatments were performed within 3 weeks. No dermal sensitisation reaction was seen at 24 and 48 hours after a challenge (patch technique; 14 days after the last induction insult; concentration 10%). Following a re-challenge (patch technique; 7 days after the first challenge; concentration 25%), 3 out of 20 animals exhibited barely perceptible erythema after 24 and 48 h, which were stated to be ambiguous concerning the sensitisation potential of the test substance. Hence the test item elicited no skin sensitisation potential. This study is considered to be reliable as it was conducted and reported in accordance with the current test guideline OECD TG 406 (Celanese/Bio/dynamics, 1981), and, therefore, selected as the key study.
A murine Local Lymph Node Assay (conducted according to OECD TG 429, positive controls are missing) was performed in a reliable manner (RL 2) to test the sensitisation potential of the test item (purity: not mentioned; applied concentrations: 12.5, 25, 50 and 100% (w/v); used vehicle: non or dimethylformamide).The authors report a stimulation index of 3.3 respectively 5.4 at concentrations of 50 respectively 100% nonanoic acid, thus indicating a positive result. According to the authors it is generally believed that "the LLNA does not have the capacity to discriminate between non-specific proliferation and weak sensitizing ability of strong irritants. It is hypothesized that minimal lymph node proliferation may occur following irritant exposure due to non-specific Langerhans cell migration to draining lymph nodes" (Woolhiser et al., 1998). Thus the presented SIs, can be interpreted as a false positive result and the study is considered as disregarded. Thus the strong irritant nonanoic acid is stated to be non sensitising by Montelius et al. (1998).
The same findings in the classical murine LLNA are reported by other authors (publications with low reliability - RL 3; Woolhiser et al., 1998; Gerberick et al. 2007). These authors drew also the conclusion that due to the strong irritation potential of NA it can be regarded to be not sensitising, thus supporting Montelius et al. (1998).
Due to the known fact that certain non-sensitizing irritants may yield false positive results in the LLNA, as in the case of nonanoic acid, reasearch is done to elucidate additional more conclusive endpoints. A variety of such mechanistic publications also sustain the conclusion made in the previously described studies. Ku et al. (2008a; RL 3) made use of gene expression microarrays and RT-PCR quantification method. They found, the transcripts for Ifng, Ifi27, Il12rb1, and Zbp1 were upregulated compared with vehicle control in all sensitizers (positive control), but downregulated or not significantly affected at all by any dose of the irritant NA. All of these genes are associated with T-cell proliferation in a positive manner. Another publication of these authors (Ku et al., 2008b; RL 3) stated that sensitizers, but not the irritant, NA, evoke pronounced IL-2, IL-3 and IFN-gamma protein and mRNA responses.
This proves also true for mRNA levels of Granzyme B (GzmB, which is produced by cytotoxic T-cells). Thus, the mentioned cytokines as well as GzmB are good markers for discriminating between sensitizers and irritants.
Other publications whith investigations made in other species than mouse support the negative conclusion for nonanoic acid. An in vitro study on human ex vivo skin biopsy cultures (Pistoor et al., 1996; RL 3) as well as an in vivo study (human maximisation test; Opdyke, 1978; RL 4) identify NA as a non-sensitiser.
In the publication by Kolle et al. (2019) NA showed negative results in two of three different in vitro tests for single events of sensitisation on a cellular level. The KeratinoSens and DPRA assays wshowed nagative results, the h-CLAT (CD86) a positive result. By applying the 2 out of 3 approach, the test substance would be classified as a non-sensitizer based on the negative DPRA and KeratinoSens result.
Overall, pelargonic acid lacks a skin sensitsing potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
With respect to the negative conclusions in the key study on skin sensitisation no classification according to Regulation (EC) No 1272/2008 is required.
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