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EC number: 205-055-6 | CAS number: 132-27-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 - 31 Mar 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Sodium 2-biphenylate
- EC Number:
- 205-055-6
- EC Name:
- Sodium 2-biphenylate
- Cas Number:
- 132-27-4
- Molecular formula:
- C12H9NaO
- IUPAC Name:
- sodium 2-phenylphenolate
- Details on test material:
- Batch No.: MM940104
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., USA
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: 365 - 446 g
- Housing: 5 animals were housed per cage.
- Diet: Purina Certified Guinea Pig Chow #5026, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 1 week
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 02 Mar 1994 To: 31 Mar 1994
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- 3 single treatments (6 h exposure) every 7 days within 21 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- single treatment (6 h exposure)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: A preliminary skin irritation study was conducted in order to determine a slightly irritating dose level as well as to establish the highest non-irritating concentration of the test substance. Guinea pigs were clipped free of hair on the left and right side the day prior to dosing. Single application of a 0.4 mL aliquot of a 0.1, 0.5, 1, 5 or 10% solution of the test substance in distilled water was topically applied to the skin for 6 h, in up to 3 application sites per animal. 2 guinea pigs were used per dose level. Based on the results of this preliminary skin irritation study, the dose levels 1, 5 and 10% solutions of the test substance in distilled water produced moderate to marked erythemas after 24 and 48 h, respectively. The treatment group exposed to the dose level of 0.5% showed slight erythema in 1/2 guinea pigs at the 48-h reading time point. No erythema were observed in both animals at the 0.1% dose level. Edema were not determined in all treatment groups at the 24- and 48-h reading time points, respectively. Thus, based on the results of this study, a dose level of 0.1% was considered to be the highest non-irritant concentration and 0.5% the highest concentration causing mild-to-moderate skin irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: positive control
- Site: left flank
- Frequency of applications: every 7 days
- Duration: 0 - 21 Days
- Concentration: 0.5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 35 (challenge)
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: positive control
- Site: right flank
- Concentration: 0.1%
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- 10 naïve male guinea pigs, 5 received a 0.1% solution of the test substance in distilled water and 5 received the positive control.
- Positive control substance(s):
- yes
- Remarks:
- (10% solution of [trade name] (CAS 1675-54-3) epoxy resin in dipropylene glycol monomethyl ether)
Results and discussion
- Positive control results:
- Challenge application with the positive control caused slight to moderate erythema, considered to reflect a hypersensitivity response, at the test site on nine of ten animals, with no effect noted in the corresponding naïve control animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 0.5%; Challenge: 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor edema were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.5%; Challenge: 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor edema were observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 10%; Challenge: 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Very slight, slight or moderate erythema (scores of 0.5 - 2) were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 10%; Challenge: 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Slight or moderate erythema (scores of 1 - 2) were observed.
- Group:
- negative control
- Remarks on result:
- not measured/tested
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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