3,3'-iminodi(propylamine)

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo study already available

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Method according to the Federal Register, Vol . 38, No. 187 (27.09.73), § 1500 .42 and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, p .51

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-iminodi(propylamine)

EC Number:

200-261-2

EC Name:

3,3'-iminodi(propylamine)

Cas Number:

56-18-8

Molecular formula:

C6H17N3

IUPAC Name:

bis(3-aminopropyl)amine

Details on test material:

- Analytical purity: 99%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: M. GAUKLER (6050 Offenbach)
- Weight at study initiation: 2.56 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 µl

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

6 (3 males, 3 females)

Details on study design:

SCORING SYSTEM: Follows OECD guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

3 - 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: opacity of the cornea could not be scored after 72 h due to severe ulcerations

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h -8 d

Score:

0 - 1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: changes in the iris could not be scored after 72 h due to severe ulcerations

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h - 8d

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: redness of the conjuctivae could not be scored after 72 h due to severe ulcerations

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

In 2 out of 6 animals after 72 h and all animals after 8 d severe ulcerations were observed. Further oberservations were: grey/white nictating membrane, sticky eyes, severe suppuration, grey/white mucous membrane, blood.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information

Conclusions:

Based on the findings of the study Dipropylenetriamine was judged corrosive to the eyes.

Executive summary:

Dipropylenetriamine was applied to conjunctival sac of the eyes of 6 Vienna White rabbits. Animals were observed after 24, 48 and 72 hours and up to 8 days after the treatment. The application caused corrosion (irreversible), predominantly expressed by severe corneal opacity.