Ethylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 - 22 Nov 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Method: BASF-Test.
Observations after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

GLP compliance:

no

Remarks:

did not exist at that time

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenediamine

EC Number:

203-468-6

EC Name:

Ethylenediamine

Cas Number:

107-15-3

Molecular formula:

C2H8N2

IUPAC Name:

ethane-1,2-diamine

Constituent 2

Reference substance name:

Ethylendiamine

IUPAC Name:

Ethylendiamine

Details on test material:

- Name of test material (as cited in study report): Aethylendiamin
- Analytical purity: 99 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach
- Weight at study initiation: 2.25 kg
- Diet: Ssniff-standarddiat/Kaninchen, ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline-control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: see detailed table in remarks on results.

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Any other information on results incl. tables

Findings:

animal1/animal2

Time	Opacity	Iritis	Erythema	Chemosis
1 h	3/3	0/0	2/2	2/2
24 h	3/3	0/0	2/2	2/2
48 h	-/-	-/-	-/-	-/-
72 h	#/#	#/#	#/#	3/3
8 d	#/#	#/#	#/#	3/3

-/-: The original readings at 48 h are missing.

#/# : A thick purlulence layer made an evaluation impossible.

1 h post application heavy opacity and distinct irritation of the mucous membrane were observed and bloody eye discharge occured. Grey discoloration of nictitating and mucous membrane. The severe corneal opacity is regarded to be irreversible.

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Ethylene diamine is corrosive to the rabbit eye.

Executive summary:

Two Vienna White rabbits were exposed to 50 µl ethylene amine in one eye. Observations were made after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. Irreverible damage to eyes was reported.