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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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:
test group
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 group
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 group
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:
Reading:
other: 4th reading
Hours after challenge:
72
Group:
test group
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:

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.