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EC number: 205-399-7 | CAS number: 140-11-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 June 1985 - 9 August 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- no guideline followed
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Twenty animals per test group were injected intradermally on day 0 with different concentrations or the test material in physiological saline. Each animal also received two intradermal injections of 50% v/v Freund's complete adjuvant (FCA) in distilled water and two injections of the test or control material in the FCA formulation. On day 7 or 8, the test animals in the groups received different concentrations of the test material in petrolatum topically under elastoplast bandage wrappings for 48 hours. On day 19 or 21, the respective induced test animals were challenged with the three concentrations of the test material in petrolatum plus undiluted petrolatum topically under Elastoplast bandage wrappings for 24 hours. On the day after removal of the topical application, the sites were depilated. Later that day and again the next day, the sites were graded for erythema responses (24 and 48 hour responses).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An older guinea pig maximisation test is available that is acceptable for classification purposes; further testing by the LLNA method is not considered necessary
Test material
- Reference substance name:
- Benzyl acetate
- EC Number:
- 205-399-7
- EC Name:
- Benzyl acetate
- Cas Number:
- 140-11-4
- Molecular formula:
- C9H10O2
- IUPAC Name:
- benzyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Benzyl Acetate
- Physical state: Liquid with strong odour
- Storage condition of test material: refrigeration in covered amber glass bottles
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Benzyl Acetate
- Physical state: Liquid with strong odour
- Storage condition of test material: refrigeration in covered amber glass bottles
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lab Animal Supply Company
- Age at study initiation: not stated
- Weight at study initiation: 300 - 400 g
- Housing: singly in wire mesh suspension cages
- Diet (e.g. ad libitum): Purina Guinea Pig Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
IN-LIFE DATES: From: 9 July 1985 To: 2 August 1985
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Primary irritation: 100, 50, 25, 10, 5, 2.5, 1.25 and 0.625% v/v
Induction - intradermal:
- Site 1: 50% v/v FCA in distilled water (all groups)
- Site 2: 10% test substance in saline (tes group), undiluted saline (control group)
- Site 3: 10% test substacne in FCA (test group), 50% FCA in saline (control group
Induction - Topical: 30% v/v test substance in petrolatum to all sites
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Primary irritation: 100, 50, 25, 10, 5, 2.5, 1.25 and 0.625% v/v
Induction - intradermal:
- Site 1: 50% v/v FCA in distilled water (all groups)
- Site 2: 10% test substance in saline (tes group), undiluted saline (control group)
- Site 3: 10% test substacne in FCA (test group), 50% FCA in saline (control group
Induction - Topical: 30% v/v test substance in petrolatum to all sites
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
Primary irritation
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: -
- Test groups:
Induction - intradermal:
Site 1: 50% v/v FCA in distilled water (all groups)
Site 2: 10% test substance in saline (tes group)
Site 3: 10% test substacne in FCA (test group)
Induction - Topical: 30% v/v test substance in petrolatum to all sites
- Control group: 1
Induction - intradermal:
Site 1: 50% v/v FCA in distilled water (all groups)
Site 2: undiluted saline (control group)
Site 3: 50% FCA in saline (control group)
Induction - Topical: Undiluted petrolatum to all sites
- Site: 3 sites each side of the midline
- Frequency of applications: Once for each type of induction
- Duration: One intradermal, the other topical for 48 hours
- Concentrations: intradermal 30%, topical 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 19 or 21
- Exposure period: 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: the maximum non-irritating concentration and two lower concentrations
- Evaluation (hr after challenge): 4-8 hours after patch removal (24-hour reading) and the next day (28-hour reading) - Challenge controls:
- 12 animals, male/female, Maximum non-irritating concentration
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 3
- Total no. in group:
- 12
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Undiluted vehicle. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 3
- Total no. in group:
- 12
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Undiluted vehicle. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
Any other information on results incl. tables
Group |
Concentration |
Number of responders / Number treated |
Mean severity (24 hours) |
Mean severity (48 hours) |
Class of response |
Test |
10 |
0/20 |
0.5 |
0.5 |
Weak |
Test |
3 |
0/20 |
0.5 |
0.6 |
Weak |
Test |
1 |
0/20 |
0.5 |
0.6 |
Weak |
Control |
10 |
3/12 |
0.5 |
0.5 |
Mild |
Control (vehicle) |
Undiluted |
8/20 |
0.5 |
0.8 |
Moderate |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The responses to the test substance were rated as weak. Benzyl acetate is not considered to be sensitising. According to Regulation (EC) No. 1272/2008, no classification is warranted.
- Executive summary:
Twenty animals per test group were injected intradermally on day 0 with different concentrations or the test material in physiological saline. Each animal also received two intradermal injections of 50% v/v Freund's complete adjuvant (FCA) in distilled water and two injections of the test or control material in the FCA formulation. On day 7 or 8, the test animals in the groups received different concentrations of the test material in petrolatum topically under elastoplast bandage wrappings for 48 hours. On day 19 or 21, the respective induced test animals were challenged with the three concentrations of the test material in petrolatum plus undiluted petrolatum topically under Elastoplast bandage wrappings for 24 hours. On the day after removal of the topical application, the sites were depilated. Later that day and again the next day, the sites were graded for erythema responses (24 and 48 hour responses).
According to Regulation (EC) No. 1272/2008, no classification is warranted.
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