1,2,4-Benzenetricarboxylic acid, mixed lauryl and octyl triesters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10.4.2015 - 26.4.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the temperature was above control (17-23 °C), at the 24 h confirmatory test dosing time for 2 animals was earlier than 4 h, no impact on study results

GLP compliance:

yes (incl. QA statement)

Remarks:

Health Care Inspectorate of Health, Welfare and Sport, Den Haag, The Netherlands

Test material

Test material information

Constituent 1

Reference substance name:

1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octy triesters

IUPAC Name:

1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octy triesters

Constituent 2

Reference substance name:

tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate

EC Number:

700-342-7

Cas Number:

1163775-81-2

Molecular formula:

C14H47O6 to C18H55O6

IUPAC Name:

tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate

Constituent 3

Reference substance name:

Linplast 812 TM

IUPAC Name:

Linplast 812 TM

Specific details on test material used for the study:

N/A

Test animals

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shenyang pharmaceutical University Experimental Animal Center (Liaoning, P.R. China)
- Age at study initiation: young adult (at receipt 84-140 days)
- Weight at study initiation: 1602.5-2050.4 g
- Housing: single housing in suspended, stainless wire cages (50cmx35cmx30 cm) on cage racks (167cmx70cmx171cm)
- Diet (e.g. ad libitum): pellet breeding rabbit diet, ad libitum
- Water (e.g. ad libitum): Water was purified using the HT-R01000, ad libitum
- Acclimation period: 9 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-26.1
- Humidity (%):40-56
- Air changes (per hr): not mentioned
- 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:

72 h (no irritation after 72 h)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: right back, application of the test substance on a skin area of approx. 6 cm²
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.

Approximately 24 hours before the test, the back and flanks of each animal was clipped free of fur. Only animals with healthy, intact skin by gross observation were used for the study. Cleared area was approximately 6cm x 6 cm. Two sites (2.5cm x 2.5cm) below the suprascapular area, on each side of the mid-line were selected as application sites. The other site (A) was served as a control site. One site (B) was designated as the test substance application site.

Approximaltely 0.5 ml of the test item was applied to the gauze patch (2.5cm x 2.5cm) on non-irritating adhesive tape covered by medical film. The control site (A) was covered with an untreated patch. The treated patch was placed over on the right back of clipped area (B). The skin was secured by using elastic bandage and medical paper tape to have a good contact with skin and to prevent animals from ingestion or inhalation of the test substance. All animals were kept in a semi-occlusive dressing for 4 hours.

Patches were removed after 4 hours. The residual test substance was gently wiped off the application site by cotton moistened with tepid water.

Skin reactions: Dermal observations for erythema, eschar and edema formation were conducted and recorded immediately and at 1, 24, 48 and 72 hours after patch removal. Because there were no dermal irritation in any animal at 72 h, no further observation was required.


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0

Other effects:

N/A

Any other information on results incl. tables

All animals showed expected gain in body weight during the course of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item 1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octyl triesters did not produce any evidence of skin irritation and corrosion in Japanese White rabbits.

Executive summary:

The study was performed to assess the acute dermal irritation/corrosion of 1,2,4 -Benzenetricarboxylic acid, mixed dodecyl and octyl ester in Japanese White Rabbits according to OECD 404. Three male rabbits were used for the study. A quantity of 0.5 ml test item was applied to right side of back skin of each animal for an exposure period of four hours. The untreated skin on the left back area of the animal served as the control. Observations of treated skin response were conducted immediately and at 1, 24, 48 and 72 hours after patch removal. Body weights were collected during this test.

No evidence of skin irritation was noted during the study with the mean scores of skin reactions of 0 at 24, 48 and 72 hours after patch removal. No abnormal clinical signs were noted and all animals showed expected gain in body weight during the course of the study.

The test item 1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octyl triesters did not produce any evidence of skin irritation and corrosion in Japanese White rabbits.