2,5-bis(p-toluidino)terephthalic 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: Guideline study (OECD TG 404).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,5-bis(p-toluidino)terephthalic acid

EC Number:

233-651-6

EC Name:

2,5-bis(p-toluidino)terephthalic acid

Cas Number:

10291-28-8

Molecular formula:

C22H20N2O4

IUPAC Name:

2,5-bis[(4-methylphenyl)amino]benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Toluidinosäure gemahlen
- Substance type: brown particulates.
- Storage condition of test material: in the darkness at 22 °C in a fume cupboard.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed.
- Weight at study initiation: 2.6-3.1 kg.
- Housing: individually.
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum.
- Water: deionised, chlorinated water, ad libitum.

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.35 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen).

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Baiersdorf).
- Type of wrap if used: semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm mains water.
- Time after start of exposure: 4 h.

SCORING SYSTEM: according to OECD TG 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of animal # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h.

Score:

0

Reversibility:

fully reversible

Remarks:

- no signs of irritation at any time

Results 2

Irritation parameter:

edema score

Basis:

other: mean of animal # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h.

Score:

0

Reversibility:

fully reversible

Remarks:

- no signs of irritation at any time

Irritant / corrosive response data:

No skin irritations were observed during the study. Individual scores for erythema and edema were 0 for all animals and all timepoints.

Other effects:

The treated skin sites showed a light violet discolouration until 24 h after exposure.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Test material toluidino acid was not irritating under these test conditions.

Executive summary:

Test material toluidino acid was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin irritations were observed during the study. The substance is found to be not irritating.