1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-02-14 to 1984-02-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles and was performed according to internationally accepted testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

EC Number:

271-089-3

EC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Cas Number:

68515-47-9

Molecular formula:

C34H58O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich diisotridecyl Phthalate

Details on test material:

- Name of test material (as cited in study report): Vestinol TD
- Substance type: pure active substance
- Physical state: liquid
- Lot/batch No.: T 53/124312173
- Other: Date of production: 1983-09-01

Test animals

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet: Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³

Duration of treatment / exposure:

4 hours

Observation period:

up to 9 days

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a linen patch (2,5 x 2,5 cm) was placed, which was covered with a
polyethylene film (6 x 6 cm). The application area was then immobilised with an elastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.34

Max. score:

8

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0.17

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0.17

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

AVERAGE SCORE (24, 48, and 72 hours)
- Erythema: 0.17
- Edema: 0.17

Other effects:

One animal showed two reddish, swollen spots of approx. 1 cm diameter on day 6, which formed small crusts later on. On
Day 8 the crusts detached.

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test.

Score at time point / Reversibility	Erythema Max. score:	Edema Max. score:
60 min	0/0/0/0/0/0	0/0/0/0/0/0
24 h	0/1/0/0/0/0	0/0/0/0/0/0
48 h	0/1/0/0/0/0	0/1/0/0/0/0
72 h	0/1/0/0/0/0	0/1/0/0/0/0
Average 24h, 48h, 72h	0.17	0.17
Reversibility *)	c.	c.
Average time (unit) for reversion	9 days	6 days

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Executive summary:

In this study, rabbits were exposed to DTDP at doses of 0.5 cm³ for 4 hours via a linen patch covered with a polyethylene film. Dermal assessment occurred daily for up to 9 days post exposure. Every animal survived exposure. One animal exhibited erythema at 24 hours and one animal exhibited edema at 48 hours, but all animals were free of any dermal irritation by day 9.