3-amino-p-toluamide

Eye irritation

Administrative data

Endpoint:

eye 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 OECD405, 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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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: 2.22 kg
- Housing: in fully air-conditioned room in a separate cage 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


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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eyes served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h after beginning of treatment

Number of animals or in vitro replicates:

1

Details on study design:

About 24 hours before the start of the study both eyes of the animal were examined
under UV light for corneal lesions after instillation of one drop of a 0.01 % fluoresceinsodium
solution. Only an animal without ocular abnormalities was used for the study.
100 mg 3-Amino-4-methylbenzamide was administered once to the conjunctival sac of
the left eye of the rabbit. The untreated eye served as a control.
24 hours after administration the treated eye was washed out thoroughly with isotonic
saline at approx. 37 °e. The eye was also washed out at designated examination times
at which discharge was observed or a corneal examination with fluorescein was
performed.
The eye was examined 1, 24, 48 and 72 hours after administration of the test substance.
At 24 and 72 hours and after 7 and 14 days, the eye was further examined for
corneal lesions under UV light after instillation of one drop of a 0.01 % fluoresceinsodium
solution. Lesions in cornea, iris or conjunctiva were graded numerically. All other changes or
toxic effects were recorded when apparent. Since effects were still present in the eye
after 72 hours, further examinations were carried out after 7 and 14 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

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

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Remarks:

14d after beginning of treatment (end of observation)

Remarks on result:

other: highest score of 2 after 72h remains unchanged after 14d

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

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

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14d after beginning of treatment (end of observation)

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

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

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14d after beginning of treatment (end of observation)

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

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

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14d after beginning of treatment (end of observation)

Irritant / corrosive response data:

In view of the unchanged cornea score of 2 after 14d after beginning of treatment a full recovery is not expected in the case of a prolonged observation period of 21 days according to effective guidelines.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification acc. to (EC) 1272/2008: H318 (causes serious eye damage).

Executive summary:

Test material was subject to a test of eye irritancy according to OECD Guideline 405. 100 mg of substance were applied to one eye of 1 animal. Mean value of the 24, 48 and 72 h readings were calculated. Due to the effect on cornea not being expected to be fully reversible within 21 days according to effective guidelines the test material was judged to be causing serious damage to the eye.