Diundecyl phthalate, branched and linear

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Methods used standard for the period. For read-across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Substances Act as described in the Federal Register, Section 1500.41 1973

Principles of method if other than guideline:

24 hour exposure on abraded and intact skin

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic acid diundecyl ester

IUPAC Name:

Phthalic acid diundecyl ester

Details on test material:

Not reported

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Six male albino rabbits. No environmental conditions reported.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of DUP as supplied applied to intact skin under 1X1 double thickness gauze square.

Duration of treatment / exposure:

24h

Observation period:

48h

Number of animals:

6

Details on study design:

TEST SITE
Haskell Laboratory study
- Area of exposure: trunk and lateral areas; area of 1" X 1" used
- % coverage: Not reported
- Type of wrap if used: double thickness gauze square covered by rubber sheeting which was loosely wrapped around the trunk and secured with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: 24h

SCORING SYSTEM: according to the system of the Federal Substances Act as described in the Federal Register, Section 1500.41 1973 A

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: 1/6

Time point:

other: 24h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 48h

Remarks on result:

other: numerical score = mild, assigned, based on current OECD 404

Results 2

Irritation parameter:

edema score

Basis:

other: 6/6

Time point:

other: 24h

Score:

0

Max. score:

0

Reversibility:

other: N/A

Remarks on result:

other: numerical score = mild, assigned, based on current OECD 404

Results 3

Irritation parameter:

erythema score

Basis:

other: 4/6

Time point:

other: 48h

Score:

1

Max. score:

1

Reversibility:

other: N/A

Remarks on result:

other: numerical score = very slight, assigned, based on current OECD 404

Results 4

Irritation parameter:

edema score

Basis:

other: 6/6

Time point:

other: 48h

Score:

0

Max. score:

0

Reversibility:

other: N/A

Remarks on result:

other: numerical score = no oedema, assigned, based on current OECD 404

Irritant / corrosive response data:

DUP produced mild-very slight erythema when applied to the intact skin of rabbits

Other effects:

Not reported

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

An assessment of dermal irritation in the rabbit following 24 hours exposure resulted in only slight erythema.

Executive summary:

An assessment of dermal irritation in the rabbit following 24 hours exposure according to FHSA test methods resulted in only slight erythema.