Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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:
Quaternary ammonium compounds, pentamethyltallow alkyltrimethylenedi-, dichlorides
EC Number:
271-762-1
EC Name:
Quaternary ammonium compounds, pentamethyltallow alkyltrimethylenedi-, dichlorides
Cas Number:
68607-29-4
IUPAC Name:
68607-29-4
Constituent 3
Reference substance name:
Diamine quaternised C16-18, C18 unsaturated
IUPAC Name:
Diamine quaternised C16-18, C18 unsaturated
Details on test material:
Redicote EN 611, an amber liquid, was received on 26 February 1987 and was stored at ambient temperature.
Redicote EN 611 (From 2000 renamed to Redicote 611) contains: 30-40% a.s.; 10-15% CaCl2 and 50-60% water.

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

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"