Quaternary ammonium compounds, N-(C16-18 and C18-unsatd. alkyl)-N,N,N',N',N'-pentamethyltrimethylenedi-, dichlorides

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Mar - 23 Mar 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: pre-GLP; Includes GLP-like QA statement.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride

EC Number:

629-716-7

Cas Number:

1211950-04-7

Molecular formula:

No molecular formula

IUPAC Name:

N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Constituent 3

Reference substance name:

Propan-2-ol

EC Number:

200-661-7

EC Name:

Propan-2-ol

Cas Number:

67-63-0

Molecular formula:

C3H8O

IUPAC Name:

propan-2-ol

Test material form:

liquid

Details on test material:

- Chemical name : N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride
- EC number : 629-716-7

“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
The concentrations cited in this memo refer to the as-received sample of Duoquad T-50.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White strain rabbits in the weight range 2.5 to 3.1 kg, prior to treatment on Day 1 and approximately 11 to 14 weeks of age were
obtained from Froxfield Rabbits, Petersfield, Hampshire. The rabbits selected for the study were all acclimated to the laboratory environment.

The rabbits were individually housed in metal cages with perforated floors in Building R 14 Room 3. They had free access to tap water and SDS
Standard Rabbit Diet. Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%. Air exchange was
maintained at approximately 19 air changes per hour and lighting was controlled to give 12 hours of artificial light (0700-1900 hours) in each 24
hour period. All animals were observed daily for signs of ill health or toxic signs.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or
conjunctival inflammation. A 0.1 ml aliquot of Redicote EN 611 was placed into the lower everted. lid of one eye of each animal. The eyelids
were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.

Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation of the eyes was aided by the use of a hand held
torch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

not specified

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

not specified

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

not specified

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Vascularization of cornea on day 7

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not specified

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not specified

Irritant / corrosive response data:

All three animals gave a "positive" response. Corneal opacification developed in all three animals and was still present seven days after instillation,
when vascularisation of the cornea was also seen in one animal. Iridial inflammation was observed in all three animals. A diffuse, crimson colouration of the conjuntivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half-closed was seen in all three animals.
A copious discharge was observed in all three animals. All three animals were killed on humane grounds, seven days after instillation, due to the
severity of the ocular reactions.

Any other information on results incl. tables

Summary of ocular lesions

Anim. No.	Effect	Hours	Days after application					Mean score cornea Days 1/2/3	Mean score iritis Days 1/2/3	Mean score redness Days 1/2/3	Mean score chemosis Days 1/2/3
		1	1	2	3	4	7
1	Cornea Iris Redness Chemosis	D 0 2 2	1 0 2 1	1 1 2 1	2 1 2 1	2 1 2 1	2 0K 1 1	1.33	0.67	2	1
2	Cornea Iris Redness Chemosis	D 0 1 2	1 1 1 3	1 1 2 2	2 1 2 3	2 1 2 3	1 1K 2 2	1.33	1	1.67	2.67
3	Cornea Iris Redness Chemosis	D 0 1 2	1 0 1 1	2 1 2 2	2 1 2 2	2 1 2 2	3V 1K 2 2	1.67	0.67	2	2

 

D Dulling of cornea

V Vascularization of cornea

K Killed

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information

Conclusions:

Instillation of Redicote EN 611 into the rabbit eye elicited a positive response in all of the three treated animals according to OECD test criteria.
Severe ocular reactions were observed including vascularization of the cornea. Based on the severity of the reactions, the test article should be
classified as corrosive under GHS.

Executive summary:

The study was conducted to asseses the irritation potential of Redicote EN 611 when instilled into the eyes of rabbits in accordance with OECD 405. 0.1 ml was instilled into one eye of three rabbits. Eye were evaluated 1 hour after instillation and again 1, 2, 3, 4 and 7 days later.

Instillation of Redicote EN 611 into the rabbit eye elicited a positive response in all of the three treated animals according to OECD test criteria. Severe ocular reactions were observed including vascularization of the cornea. Based on the severity of the reactions, the test article should be classified as corrosive under GHS.

Label requirements under GHS: Symbol "Corrosion"; Signal word "Danger"; Hazard statement "Causes serious eye damage"