[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

A readacross with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride is proposed. The substance detailed in section 1 and the analogue material are both salts of 2-(2,4-diaminophenoxy)ethanol with similar physical and chemical properties.

Data source

Reference

Reference 1

Reference Type:

other: Published secondary source

Title:

Unnamed

Year:

2006

Report date:

2006

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

EC Number:

266-357-1

EC Name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

Cas Number:

66422-95-5

Molecular formula:

C8H12N2O2.2ClH

IUPAC Name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

Details on test material:

Test item : Imexine OAJ
EC number : 266-357-1
Batch number : Op 118
Purity : 99.4%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg undiluted.

Duration of treatment / exposure:

On day 1, a 100mg sample of neat Imexine OAJ was instilled in the conjunctival sac of the left eye of the animals. The eyes were not rinsed following instillation of the test item. The non-treated right eye served as a control. The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15.

Observation period (in vivo):

The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15.

Number of animals or in vitro replicates:

3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 hours

Score:

3

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 4

Irritation parameter:

chemosis score

Max. score:

3

Remarks on result:

other: Max. duration, max. value at end of observation period related to all animals

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(cumulative)

Time point:

other: 72 hours

Score:

2.33

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 hours

Score:

1.67

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 9

Irritation parameter:

conjunctivae score

Max. score:

2

Remarks on result:

other: Max. duration, max. value at end of observation period related to all animals

Results 10

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(cumulative)

Time point:

other: 72 hours

Score:

1.89

Results 11

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 hours

Score:

1

Results 12

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 hours

Score:

1

Results 13

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 hours

Score:

1

Results 14

Irritation parameter:

iris score

Max. score:

1

Remarks on result:

other: Max. duration, max. value at end of observation period related to all animals

Results 15

Irritation parameter:

iris score

Basis:

mean

Remarks:

(cumulative)

Time point:

other: 72 hours

Score:

1

Results 16

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 hours

Score:

2

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 hours

Score:

1.33

Results 19

Irritation parameter:

cornea opacity score

Max. score:

2

Remarks on result:

other: Max. duration, max. value at end of observation period related to all animals

Results 20

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(cumulative)

Time point:

other: 72 hours

Score:

1.78

Irritant / corrosive response data:

Marked ocular reactions were observed. They included moderate to marked chemosis and slight to moderate redness of conjunctivae, slight to moderate corneal opacification and slight iridal lesions. At the end of the study (day 15), similar though less marked ocular reactions were observed.

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) was considered to be an irritant to rabbit eyes when tested undiluted. At the end of the observation period of 15 days the effects were not reversible thus justifying a category 1 classification.

Executive summary:

For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. The eye irritation potential of the substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride was assessed according to OECD guideline 405 in compliance to GLP. On day 1, a 100mg sample of neat Imexine OAJ was instilled in the conjunctival sac of the left eye of the animals. The eyes were not rinsed following instillation of the test item. The non-treated right eye served as a control. The ocular reactions were assessed 1, 24, 48 and 72 hours after instillation, as well as on day 8 and day 15. Marked ocular reactions were observed. They included moderate to marked chemosis and slight to moderate redness of conjunctivae, slight to moderate corneal opacification and slight iridal lesions. At the end of the observation period of 15 days the effects were not reversible thus justifying a category 1 classification.