Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD 404 guideline study performed according to GLP regulation

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate

EC Number:

230-638-7

EC Name:

Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate

Cas Number:

7237-83-4

Molecular formula:

C18H18O9

IUPAC Name:

1,2,4-tris[(oxiran-2-yl)methyl] benzene-1,2,4-tricarboxylate

Details on test material:

- Name of test material (as cited in study report): TKK 30009
- Trade name: LMB 5196
- Physical state: viscous liquid
- Analytical purity: > 75%
- Lot/batch No.: Z 2178
- Expiration date of the lot/batch: March 1995
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemish-pharmazeutische Fabrik D-7950 Biberach/Riss
- Weight at study initiation: 2350 to 2570 g
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: a control gauze patch moistened with distilled water was applied to the contra-lateral flank.

Amount / concentration applied:

0.5 mL of the undiluted test material was applied to the right flank of each animal.

Duration of treatment / exposure:

4 hours

Observation period:

10 days

Number of animals:

3 female animals

Details on study design:

TEST SITE
- Area of exposure: 12 - 16 cm2
- Type of wrap if used: A gauze patch covered with an aluminium foil held in place by an adhesive tape (Isoplast AG, CH-5200 Brugg)


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours


SCORING SYSTEM: According to the OECD scoring system

ERYTHEMA AND ESCHAR FORMATION:
No erythema............................................................................................................................0
Very slight erythema (barely perceptible)...........................................................................1
Well defined erythema.............................................................................................................2
Moderate to severe erythema................................................................................................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)............4


EDEMA FORMATION:
No edema...........................................................................................................................................................................................0
Very slight edema (barely perceptible)..........................................................................................................................................1
Slight edema (edges of area well defined by definite raising)....................................................................................................2
Moderate edema (raise approximately 1 mm)..............................................................................................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)................................................................4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours for each animal

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours for each animal

Score:

0

Irritant / corrosive response data:

Very slight erythema was observed in all three animals fronm the 1-hour observation to the 72-hour observation and persisted in one animal until the 7-day reading. No edema was noted during the course of the study.
No skin effects were noted on the control flanks treated with distilled water.

Any other information on results incl. tables

BODY WEIGHTS (g)

Animal no. / Sex	334 / Female	294 / Female	300 / Female
At start of the test	2570	2450	2350
After 3 days	2620	2470	2520
After 7 days	2720	2640	2710
After 10 days	2800	2770	2780

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the Commission Directive 83/467/EEC the substance can be classified as non-irritant

Executive summary:

The primary skin irritation potential was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing as well as 7 and 10 days after treatment.

 

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.

 

Very slight erythema was observed in all three animals from the 1-hour observation to the 72-hour observation and persisted in one animal until the 7-day reading. No edema was noted during the course of the study. No skin effects were observed in all animals after 10 days.

No skin effects were noted on the control flanks treated with distilled water.

 

Thus, the test item did not induce significant or irreversible damage to the skin.

 

Based upon the referred classification criteria (Commission Directive 83/467/EEC), the substance is considered to be “not irritating” to rabbit skin.