p-tert-butylaniline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study conducted prior to GLP, no guideline followed as none was available in 1982 (OECD 401: 1987). However, the available information is documented sufficiently and allows the conclusion that the study was properly conducted with a scientifically acceptable method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.42

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-tert-butylaniline

EC Number:

212-215-9

EC Name:

p-tert-butylaniline

Cas Number:

769-92-6

Molecular formula:

C10H15N

IUPAC Name:

4-tert-butylaniline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: W. Ostrup / Meerbusch
- Weight at study initiation: 2.7 kg (average)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): "Mümmel Z" (Ssniff, Soest), ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µL/ rabbit

Observation period (in vivo):

8 days (24h, 48h, 72h and 8 days)

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize-grading

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

48.5

Reversibility:

other: Presuming good healing, the eyes are practically free from damage caused after 8 days.

Remarks on result:

probability of moderate irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The study was conducted according to Code of Federal Regulations, Title 16, Section 1500.42 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the eye irritating properties of the test substance in rabbits. The primary irritation index was calculated from the individual results and according to this, the substance is moderately irritation to the eye and has to be classified as Eye Irrit. 2, H319.

Executive summary:

In an eye irritation study ( Code of Federal Regulations, Title 16, Section 1500.42), male rabbits (six animals, New Zealand White) were exposed to 100 µL of test substance (undiluted). Animals then were observed for 8 days. The primary irritation index was calculated from the individual results and according to this, the substance is moderately irritation to the eye.