2,2'-phenyliminodiethanol

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:

other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Principles of method if other than guideline:

According to BASF-internal standard: Two White Vienna rabbits received 50 mg of the test substance in the conjunctival sac of one eye. The adjacent eye received talcum powder as a control. The animals were scored 1, 24 h and 8 days after application.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-phenyliminodiethanol

EC Number:

204-368-5

EC Name:

2,2'-phenyliminodiethanol

Cas Number:

120-07-0

Molecular formula:

C10H15NO2

IUPAC Name:

2-[(2-hydroxyethyl)(phenyl)amino]ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): Dioxyäthyl-anilin

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.0 and 3.4 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: talcum powder, in the other eye of same animal

Amount / concentration applied:

ca. 50 mg

Duration of treatment / exposure:

Single application to the conjunctival sac of the eye

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE: substance was not removed
SCORING SYSTEM: readings were performed 1 h, 24 h, and 8 d after application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Test substance:
- 1 h after application: Slight redness, marked edema, slight to marked corneal opacity and corneal release was observed in both animals.
- 24 h after application: Slight redness, slight edema, and slight corneal opacity were observed in both animals. A foamy discharge was observed in one animal and secretion in the other.
- 8 days after application: Slight redness and slight corneal opacity observed in both animals.

Control substance (talcum):
- 1 h after application: Slight redness observed in both animals. Slight edema observed in one animal.
- 24 h after application: Slight redness observed in both animals.
- 8 days after application: no effects observed.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the results after 8 days, slight redness an slight corneal opacity, the test substance has to be classified as irreversible effects on the eye.