trisodium ({3-[(carboxylatomethyl)amino]propyl}{3-[(carboxylatomethyl)(C16-18, C18 unsat alkyl)amino]propyl}amino)acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed accosring to US federal methods which are comparable to the OECD guideline and the study was performed under GLP. Observations were made for 72 hours although effects were not fully reversed at that time.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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:

The animals were observed for 72 hours although the effects in one of the animals had not fully reversed at that time.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

EC Number:

307-458-3

EC Name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

Cas Number:

97659-53-5

Details on test material:

Appearance: clear orange liquid
Container: screw capped plastic bottle
Name: Ampholak 7TX

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: recognised breeders
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.3 kg
- Housing: in grid bottom metal cages, not mentioned if the housing was individual
- Diet (e.g. ad libitum): A commercially ( available antibiotic free pelleted rabbit diet (Product Ref. 680, Dalgety-Spillera Limited), ad libitum
- Water (e.g. ad libitum): Mains drinking water via automatic drinking nozzles in each cage were available ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-20
- Humidity (%): 70-90
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: June 1985

Female animals were used

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the animals

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

A single dose observed for 72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
not done

SCORING SYSTEM:
Scoring system eye irritation

Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

Area of Cornea Involved
1 One quarter (or less) but not zero
2 Greater than one quarter but less than half
3 Greater than half but less than three quarters
4 Greater than three quarters, up to whole area

Iris
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

Discharge
0 No discharge
1 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs a considerable area around the eye


TOOL USED TO ASSESS SCORE: Examination was canfined to a macroscopic observation and aids such as a binocular loupe, slit lamp or fluorescsin,staining were not employed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0.15

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: effects were only observed in one out of 6 animals

Results 2

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0.55

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: effects were only observed in one out of 6 animals

Results 3

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0.33

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: effects were only observed in one out of 6 animals

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0.05

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: effects were only observed in one out of 6 animals

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

24 hours after dosing iris inflammation and severe conjunctival irritation were apparent in one rabbit of the group, no response to treatment being observed in other, animals of the group. Moderate conjunctival irritation was maintained by the one rabbit throughout the study.

Any other information on results incl. tables

Rabbit No and sex	Region of the eye		Hours after instillation			Average 24-48-72 hours
			24	48	72
840-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	0	0	0	0
		Chemosis	0	0	0	0
		Discharge	0	0	0	0
842-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	0	0	0	0
		Chemosis	0	0	0	0
		Discharge	0	0	0	0
843-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	0	0	0	0
		Chemosis	0	0	0	0
		Discharge	0	0	0	0
845-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		1	0	0	0.3
	Conjunctivae	Redness	1	1	1	1
		Chemosis	4*	3	3	3.3
		Discharge	2	2	2	2
846-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	0	0	0	0
		Chemosis	0	0	0	0
		Discharge	0	0	0	0
847-f	Cornea	Degree of opacity	0	0	0	0
		Area	0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	0	0	0	0
		Chemosis	0	0	0	0
		Discharge	0	0	0	0

*Blistering of conjunctival-membranes

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results of this study indicate that the test material may have little irritant effect in the eye. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. The active ingredient is Amines, N-[3-[(3-aminopropyl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts (CAS no 2060541-47-9). The response observed appears to have been in an unusually sensitive animal. The animals were only observed for 72 hours and therefore it can not be judges if the effects are reversible within 21 days. However after 72 hours compared with the 24 reading the severity of the effects had decreased some in the affected animal. The active ingredient Amines, N-[3-[(3-aminopropyl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts (CAS no 2060541-47-9) may not be classified as an irritant to the eye according to GHS.

Executive summary:

According to methods similar to OECD and under GLP 0.1 ml aliquots of the test material were instilled into the right eye of each of six rabbits, the other eye remaining untreated as a control. The irritation produced in the treated eye of all rabbits was assessed 24, 48 and 72 hours after dosing. 24 hours after dosing iris inflammation and severe conjunctival irritation were apparent in one rabbit of the group, no response to treatment being observed in other , animals o f the group. Moderate conjunctival irritation was maintained by the one rabbit throughout the study.

The results of this study indicate that the test material may have little irritant effect in the eye. The response observed appears to have

been in an unusually sensitive animal. The animals were only observed for 72 hours and therefore it can not be judges if the effects are reversible within 21 days. However after 72 hours compared with the 24 reading the severity of the effects had decreased some in the affected animal. The active ingredient Amines, N-[3-[(3-aminopropyl)amino]propyl]-N’-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(carboxymethyl) derivs., sodium salts (CAS no 2060541-47-9) may not be classified as an irritant to the eye according to GHS.