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EC number: 202-627-7 | CAS number: 98-01-1
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This key study was conducted to an acceptable study design (guinea pig maximation test) is already available. The existing data are of good quality and provides clear negative response. There is also a supporting Buehler assay showing no evidence of skin sensitisation potential. These data preclude the need for further in vivo testing.
Test material
- Reference substance name:
- 2-furaldehyde
- EC Number:
- 202-627-7
- EC Name:
- 2-furaldehyde
- Cas Number:
- 98-01-1
- Molecular formula:
- C5H4O2
- IUPAC Name:
- 2-furaldehyde
- Reference substance name:
- furfural
- IUPAC Name:
- furfural
- Details on test material:
- - Name of test material (as cited in study report): furfural
- Physical appearance: colourless to dark brown liquid
- Analytical purity: 99.62%
- Lot/batch No.: 5371
- Expiration date of the lot/batch: 10 October 2003
- Storage condition of test material: Stored in the original container as supplied by the Sponsor (i.e., glass bottle), at room temperature.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Mahaveera Enterprises, Hyderabad, India
- Weight at study initiation: males 257-412 g, females 272-429 g
- Housing: 2 to 3 animals of the same sex per cage
- Diet: Guinea pig pellet diet (Amrut brand) (Pranav Agro Industries Ltd., Pune, Maharashtra, India) ad libitum
- Water: Charcoal filtered and UV sterilised water with vitamin-C (1 g/L) ad libitum
- Acclimation period: 6 days prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature: 19-24°C
- Humidity: 63-66%
- Air changes: 18 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 28 February 2003 To: 24 March 2003
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: induction intradermal = propylene glycol, induction epicutaneous = no vehicle, challenge = acetone
- Concentration / amount:
- induction intradermal: 5% furfural in propylene glycol
induction epicutaneous: undiluted
challenge: 0.2 mL of 25% furfural in acetone
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction intradermal = propylene glycol, induction epicutaneous = no vehicle, challenge = acetone
- Concentration / amount:
- induction intradermal: 5% furfural in propylene glycol
induction epicutaneous: undiluted
challenge: 0.2 mL of 25% furfural in acetone
- No. of animals per dose:
- 5 males and 5 females in control group
10 males and 10 females treated group - Details on study design:
- RANGE FINDING TESTS:
2 males and 2 females (clipped skin) injected intradermally with 0.1 mL of 0.5, 1, 2.5 and 5% in propylene glycol
2.5% = very slight erythema observed at 24 and 48 hours
5% = very slight erythema and oedema at 24 and 48 hours
The 5%, being mild to moderate irritant dose was selected for intradermal injection for the main study.
2 males and 2 females were epicutaneous (clipped skin) exposed to 0.2 mL of 25, 50, 75 and 100% for 24 hours. (Vehicle = 80% ethanol)
100% was selected for the epicutaneous induction, based on very slight erythema and oedema at 24 hours as well as 48 hours
25% was selected as non-irritant concentration for the challenge phase
MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INDUCTION
- No. of exposures: 3 pairs of injections at a single timepoint
- Test groups:
1:1 mixture (v/v) of Freud's Complete Adjuvant (FCA) with distilled water
5% furfural in propylene glycol
5% Furfural in propylene glycol formulated in a 1:1 mixture (v/v) FCA with distilled water
- Control group: propylene is injected in the place of Furfural
- Site: scapular region each three injections on both sites of the back of the animal
TOPICAL INDUCTION (no pre-treatment with sodium lauryl sulphate required)
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 0.2 mL furfural
- Concentrations: undiluted
- Control group: 0.2 mL distilled water
- Site: left flank
- Frequency of applications: single
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- Test groups and control groups: 0.2 mL 25% furfural in acetone
- Site: right flank
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- control groups: 0.2 mL 25% furfural in acetone
- Site: right flank
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole (reliability check JRF 4125)
Results and discussion
- Positive control results:
- 24 hours after challenge, 12/20 test and 0/10 controls had discrete or patchy erythema. 48 hours after challenge, 7/20 and 0/10 controls had discrete or patchy erythema. The results of this study confirmed the skin sensitisation potential of 2-mercaptobenzothiazole and thereby the sensitivity and reliability of the study. 2-mercaptobenzothiazole is a moderate skin sensitiser.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- not reported
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- Dicrete or patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- not reported
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- Dicrete or patchy erythema
Any other information on results incl. tables
Grade of eryththema in the test animals which responded = grade1 discrete or patchy erythema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Furfural is not a skin sensitiser in the Guinea Pig maximisation test
- Executive summary:
Since a sensitization rate of only 15% was observed in the present study using an adjuvant (guinea pig maximisation test) furfural is classified as a non-sensitiser as per OECD Harmonised System for Classification of Chemicals (2001)
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