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EC number: 201-622-7 | CAS number: 85-68-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Not sensitising - Migrated information - See Material and Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 December 1979 to 8 February 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline is available for the conduct of sensitization testing in humans
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Shelanski HA and Shelanski MD (1953). A new technique of human patch tests. Proceedings of the Scientific Section of the Toilet Goods Association, No. 19, 46-49.
Substance applied to a patch of at least 6.5 square cm for 24 hr on 3 days/week for a total of 5 weeks, allowing the skin to recuperate for 24 hr between exposures. 2-3 weeks after the final induction treatment the test substance is reapplied for usually 48 hr. This method was reported to detect not only primary sensitizers and primary irritants but also cumulative irritants. - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted
Test material
- Reference substance name:
- Benzyl butyl phthalate
- EC Number:
- 201-622-7
- EC Name:
- Benzyl butyl phthalate
- Cas Number:
- 85-68-7
- Molecular formula:
- C19H20O4
- IUPAC Name:
- 1-benzyl 2-butyl benzene-1,2-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Santicizer 160
- Substance type: no data
- Physical state: liquid
- Analytical purity: > 99.9%
- Impurities (identity and concentrations): benzyl chloride 1.3 ppm; benzal chloride 4.8 ppm
- Composition of test material, percentage of components: no data
- Purity test date: 12 October 1979
- Lot/batch No.: DK 788
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- 200 human subjects completed the single dose study (out of 208 that started it)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 15
- Exposure period: 24 hr
- Test groups: Two groups each receiving the same treatment
- Control group: no
- Site: no data
- Frequency of applications: three times weekly on alternate weekdays for 3 weeks, then a 2-week break (during Christmas period) followed by a further 2 weeks of thrice weekly application
- Concentrations: 0.2 ml of undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after the last induction exposure
- Exposure period: 24 hr
- Test groups: Two groups each receiving the same treatment
- Control group: no
- Site: no data; new site to that used for induction
- Concentrations: 0.2 ml of undiluted test substance
- Evaluation (hr after challenge): 0, 24, 48 and 72 hr by testing laboratory, then self assessment for a further week. - Challenge controls:
- no
- Positive control substance(s):
- no
- Remarks:
- not ethical
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
- Reading:
- other: 4th reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: other: 4th reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0.2 ml of undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 0.2 ml of undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no effects.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Santicizer 160 (butyl benzyl phthalate) showed no sensitizing potential when applied to the skin of 200 human volunteers in a repeated-dose patch test.
- Executive summary:
Santicizer 160 (butyl benzyl phthalate) was assessed for its skin sensitizing potential in humans using a repeated insult patch test method.
During the induction phase 200 healthy volunteers were exposed to 0.2 ml of the undiluted test substance applied to an occusive patch for 24 hours on fifteen separate occasions; after a 2 week period the same dose was applied as a challenge (24 -hour covered) to a new area of the skin. The skin was assessed for irritation after each induction exposure and for sensitization 0, 24, 48 and 72 hours after the challenge.
No evidence of sensitization (or irritation) was reported for any of the volunteers during the study.
Santicizer 160 (butyl benzyl phthalate) showed no skin sensitization (or irritation) potential in healthy human subjects in a repeated insult patch test.
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