1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-05-24 to 1988-05-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test substance not described in sufficient details.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

EC Number:

271-094-0

EC Name:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

Cas Number:

68515-51-5

Molecular formula:

C20H30O4 - C28H46O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

Details on test material:

- Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature in a glass screw-top bottle
- Other: none

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.25 - 2.51 kg
- Housing: single housing in suspended metal cages
- Diet (e.g. ad libitum): free access to Rabbit Diet, supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): free access to mains drinking water throughout the study
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 19
- Humidity (%): 68 - 75
- 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 mL

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

5 females, 1 male

Details on study design:

TEST SITE
- Area of exposure: clipped skin on the dorsal/flank area, intact epidemis
- % coverage: not mentioned
- Type of wrap if used: On the application area a gauze patch (2.5 cm x 2.5 cm) was placed. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approx. size 2.5 cm x 4.0 cm). The trunk of the animals was wrapped in an elasticated corset (TUGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, ¿ The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics¿

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.72

Max. score:

8

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0.61
- Edema: 0.11

Other effects:

none

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	Edema
	Max. score: 4	Max. score: 4
60 min	0/0/1/0/0/1	0/0/0/0/0/0
24 h	0/0/2/0/1/2	0/0/1/0/0/1
48 h	1/1/1/1/1/1	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0.61	0.11
Reversibility*)	c.	c.
Average time (unit) for reversion	72 hours	48 hours

 

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

 

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Very slight erythema was noted at two treated skin sites on hour after removal of the patches. Very slight or well-defined erythema, with or without very slight oedema, was noted at three treated skin sites at the 24 h observation. Very slight erythema persisted in all treated skin sites at the 48 h observation. All treated skin sites appeared normal at the 72 h observation.

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters produced a primary dermal irritation index (PDII) of 0.72 was classified as slightly irritant to rabbit skin.

Executive summary:

The study was performed to assess the irritancy potential of 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters to the skin of the New Zealand White rabbit. The study was designed to comply with the requirements of the USA Environmental Protection Agency (EPA).

A single 4 -hour, semi-occluded application of the test material to the skin of six rabbits produced very slight to well-defined erythema with or without very slight oedema. All treated sites appeared normal 72 hours after treatment.

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters produced a primary dermal irritation index (PDII) of 0.72 and should not be classified according to EU Nr. 1272/2008.