Benzyl butyl phthalate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 skin irritation testing in humans

Cross-reference

Reason / purpose for cross-reference:

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. This method was reported to detect not only primary irritants but also cumulative irritants.

GLP compliance:

no

Test material

Test material information

Constituent 1

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:
- 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

Test animals

Species:

other: 200 human subjects completed the single dose study (out of 208 that started it)

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 100%; undiluted

VEHICLE
none

Duration of treatment / exposure:

Three times weekly for 24 hr each application on alternate weekdays for 3 weeks, then a 2-week break (during Christmas period) followed by a further 2 weeks of the same thrice-weekly applications.

Observation period:

Examined for signs of irritation on removal of each patch and 24 hr later.

Number of animals:

200 human subjects completed the single dose study (out of 208 that started it)

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: Parke-Davis Readi-Bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Reactions judged by the investigators to be due to the test substance and not, for example, to the adhesive dressing were scored as follows:
? - questionable change
1/2 - mild erythema covering less than half of the contact site
1 - erythema confined to the contact site which exceeds that of the untreated skin
2 - erythema confined to the contact site which definitely exceeds that of the untreated skin, with or without papules
3 - erythema, with some skin hardening, with or without papules
4 - erythema, skin hardening, with one or more complications, such as extension beyond the margins of the contact area, vesiculation or ulceration

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Remarks:

0

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Remarks:

0 and 24 hr after patch removal, repeated on alternate weekdays for 5 weeks

Results 2

Irritation parameter:

erythema score

Remarks:

0

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effect

Remarks on result:

no indication of irritation

Remarks:

0 and 24 hr after patch removal, repeated on alternate weekdays for 5 weeks

Irritant / corrosive response data:

No irritant or corrosive responses

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Santicizer 160 (butyl benzyl phthalate) showed no irritating 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 potential to cause skin irritation 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 occlusive patch for 24 hours on fifteen separate occasions. The skin was assessed for irritation after each induction exposure.

No evidence of irritation (or sensitization) was observed by the investigators or reported by any of the volunteers during the study.

Santicizer 160 (butyl benzyl phthalate) showed no skin irritation potential in healthy human subjects in a repeated insult patch test.