3-amino-p-toluamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000 -2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD404, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-p-toluamide

EC Number:

243-039-0

EC Name:

3-amino-p-toluamide

Cas Number:

19406-86-1

Molecular formula:

C8H10N2O

IUPAC Name:

3-amino-p-toluamide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Germany
- Strain: Albino New Zealand rabbit
- Age at study initiation: no data
- Weight at study initiation: 2.2 - 3.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssnif~ K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimatization: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

deionized

Controls:

not required

Amount / concentration applied:

500 mg / 0,3 ml vehicle per animal

Duration of treatment / exposure:

4h

Observation period:

72 h after patch removal

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g 3-Amino-4-methylbenzamide pasted with 0.3 ml deionized water. The substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced byBeiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE (see Appendix "Scale for scoring dermal reactions", page 11). All other changes of the skin were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: mean of 24, 48, 72 h after beginning of treatment

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h after patch removal

Remarks on result:

other: highest mean score of a single animal: 0.33 for 1 of 3

Results 2

Irritation parameter:

edema score

Basis:

animal: # 1-3 each

Time point:

other: mean of 24, 48, 72 h after beginning of treatment

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification acc. to (EC) 1272/2008: not irritating

Executive summary:

Test material was subject to a test of skin irritancy according to OECD Guideline 404. 500 mg of substance were applied to the skin of three rabbits under semi-occlusive conditions for 4 h. The scoring of skin reactions was performed after 24, 48 and 72h h after end of exposure.Mean values of the 24, 48 and 72 h readings were calculated for each animal.

Only slight effects (erythema mean score: <=0.33, edema mean score: 0) below the threshold for classification were determined for the intact skin. All effects were fully reversible. Based on these findings the test material was judged not to be irritating to skin.