Registration Dossier
Registration Dossier
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EC number: 205-851-3 | CAS number: 156-38-7
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 NTIS study report.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Summary of toxicity studies for 4-METHOXYPHENYLACETIC ACID (MPAA)
- Author:
- National Technical Information Service
- Year:
- 1 991
- Bibliographic source:
- National Technical Information Service, OTS0530656-1 (1991)
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Guinea pig maximisation test was used to test the sensitizing capability of 4 methoxyphenyl acetic acid in Hartley male guinea pigs.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Sufficient for classification .
Test material
- Reference substance name:
- 4-methoxyphenylacetic acid
- EC Number:
- 203-166-4
- EC Name:
- 4-methoxyphenylacetic acid
- Cas Number:
- 104-01-8
- Molecular formula:
- C9H10O3
- IUPAC Name:
- (4-methoxyphenyl)acetic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): 4-methoxyphenylacetic acid
- Molecular formula : C9H10O3
- Molecular weight : 166.175g/mol
- Smiles notation : c1(ccc(OC)cc1)CC(O)=O
- InChl : 1S/C9H10O3/c1-12-8-4-2-7(3-5-8)6-9(10)11/h2-5H, 6H2, 1H3, (H,10,11)
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):4-METHOXYPHENYL.ACETIC ACID
- Molecular formula: C9H10O3
- Molecular weight : 166.175 g/mol
- Substance type: Organic
- Physical state: Solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal injection - propylene glycol as a vehicle wilh and without Freund's adjuvant Epicutaneous route- propylene glycol
- Concentration / amount:
- intradcmal injection - 5%
Epicutaneous route- 5% - Day(s)/duration:
- Epicutaneous application was performed eight days later of Intradermal induction .
Challenge
- Route:
- other: Epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 75%
- Day(s)/duration:
- 24 hour
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: The dose levels for challenge (75% in petrolatum) was based on a topical range -finding study to select the highest non-irritating dose which was also the highest practical dose for this material.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 8 days
- Test groups:1 test group
- Control group:Yes
- Site: Not specified
- Frequency of applications: 2
- Duration:8 days
- Concentrations:
intradcmal injection - 5%
Epicutaneous route- 5%
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 2 week
- Concentrations: 75% preparation in petrolatum
- Exposure period:24 hr
- Evaluation (hr after challenge): 24 and 48 hrs - Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- DNCB (Dinitrochlorobenzene)
Results and discussion
- Positive control results:
- 100% response was observed .
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Erythema and edema were observed
- Remarks on result:
- other: No sensitization was observed.
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema and edema were examined
- Remarks on result:
- other: Sensitization was observed.
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Slight sensitization was observed
- Remarks on result:
- other: Slight sensitization was observed in one animal
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No sensitization was observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- At the 24hour examination, 1/20 animals demonstrated a slight response to the challenge dose no animal demonstrated a response at the 48 hour examination. Negative controls showed minimal response with 1/10 animals showing minimal irritation at 24 hours only. Positive control (DNCB) demonstrated a 100% response.4-Methoxyphenylacetic Acid (MPAA) was considered to be a non sensitizing to guinea pig under test condition.
- Executive summary:
Guinea pig maximisation test was used to test the sensitizing capability of 4 methoxyphenyl acetic acid in Hartley male guinea pigs.
The shaved skin of twenty Hartley male guinea pigs was treated with the test material (a solid) by intrademal injection (as a 5% solution in propylene glycol as vehicle with and without Freund's adjuvant) and then by topical application (5% in propylene glycol) eight days later. Two weeks after the final induction administration, animals were challenged with the test material as a 75% preparation in petrolatum using a 24-hour dermal exposure. Ten non-induced animals were also challenged and Served as control. The site of exposure was examined for erythema and edema 24 and 48 hours following removal of the test material. 'The dose levels for challenge (75% in petrolatum) was based on a topical range-finding study to select the highest non-irritating dose which was also the highest practical dose for this material. At the 24hour examination, 1/20 animals demonstrated a slight response to the challenge dose no animal demonstrated a response at the 48 hour examination. Negative controls showed minimal response with 1/10 animals showing minimal irritation at 24 hours only. Positive control (DNCB) demonstrated a 100% response. 4-Methoxyphenylacetic Acid (MPAA) was found to be a non sensitizing to guinea pig under test condition. Therefore 4-Methoxyphenylacetic Acid (MPAA, CAS no-104 -1 -8) was considered to be a non sensitizing .
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