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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 20th to 21 January 1993.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate
EC Number:
947-471-7
Molecular formula:
C22H47N2O.CH3O4S - C3H8O2 - C24H51N2O.CH3O4S
IUPAC Name:
Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate
Test material form:
cream / paste
Remarks:
cream coloured paste

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.96 kg
- Housing: individual housing in a suspended metal cage
- Diet: free access throughout the study (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: free access throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22 °C
- Humidity: 58 - 61 %
- Air changes: approximately 15 changes per hour
- Photoperiod: 12 hours light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 and 24 hours after treatment.
Number of animals or in vitro replicates:
1
Details on study design:
SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 and 24 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"). Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: a standard ophthalmoscope as a light source

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
other: the animal was killed after 24h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
other: the animal was killed after 24h
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
other: the animal was killed after 24h
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Reversibility:
other: the animal was killed after 24h
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of translucent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were corneal sloughing, a dulling of the normal lustre of the corneal surface and petechial haemorrhage or a white appearance of the nictitating membrane. The animal was showing signs of pain and discomfort and was therefore killed for humane reasons immediately after the 24-hour observation in accordance with current U.K. Home Office guidelines. No further animals were treated.
The test item produced a maximum total score of 61.0 and was considered to be at least a severe irritant (Class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classifi-cation system (based on one rabbit only).

Any other information on results incl. tables

Individual scores and total scores on tested rabbit are provided below:

Time after treatment

1h

24h

Cornea

E = degree of opacity

d

2 Sl

F = area of oapacity

4

4

Score (E×F)×5

0

40

Iris

D

1

1

Score (D×5)

5

5

Conjunctivae

 

 

A = Redness

2

2 WPt

B = Chemosis

2

3

C = Discharge

3

3

Score (A+B+C)×2

14

16

Total score

19

61

 

Sl = sloughing of the cornea

W = white appearance of nictitating membrane

Pt = petechial haemorrhage of nictitating membrane

D = dulling of the normal Iustre of observation

Applicant's summary and conclusion

Interpretation of results:
other: Category 1 (serious eye damage) based on criteria in the CLP Regulation (EC 1272/2008).
Conclusions:
The test item causes serious eye damage.
Executive summary:

A study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit, following OECD guideline 405 (1987).

A single instillation of the test item to the non-irrigated eye of one rabbit produced areas of translucent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were corneal sloughing, a dulling of the normal lustre of the corneal surface and petechial haemorrhage or a white appearance of the nictitating membrane.

The test item cause serious eye damage. According to CLP Regulation (EC 1272/2008) the test item is classified as category 1.