2,5-dianilinoterephthalic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,5-dianilinoterephthalic acid

EC Number:

233-302-8

EC Name:

2,5-dianilinoterephthalic acid

Cas Number:

10109-95-2

Molecular formula:

C20H16N2O4

IUPAC Name:

2,5-bis(phenylamino)benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Anilosäure, Dianiloterephthalsäure, 2,5-Dianiloterephthalsäure

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2,6 kg to 3,4 kg
- Housing: Individually in stainless steel cages, air-conditioned
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Polyethyleneglycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg mixed with 0.4 ml Polyethyleneglycol 400

Duration of treatment / exposure:

Duration of treatment was 4 hours. After treatment residual test substance was removed with lukewarm tap water.

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 97, 98, 100 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: initial slight reactions (erythema) were fully reversible within 24 h

Results 2

Irritation parameter:

edema score

Basis:

animal: # 97, 98, 100 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Other effects:

Staining produced by the test item was present at all reading time points.

Any other information on results incl. tables

Animal no	Evaluation interval after removal of dressing	Erythema score	Edema score	Violet staining
97	30 – 60 min	1	0	X
98		1	0	X
100		1	0	X
97	24 h	0	0	X
98		0	0	X
100		0	0	X
97	48 h	0	0	X
98		0	0	X
100		0	0	X
97	72 h	0	0	X
98		0	0	X
100		0	0	X

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test, the test item is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g test item mixed with 0.4 ml Polyethyleneglycol 400 to the intact shaved skin of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. 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. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were fully reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals throughout the whole study. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. Based on that, the test item is considered to be "not irritating" to rabbit skin.