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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited information on test procedure. Study was not conducted according to the OECD principle of Good Laboratory Practive (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register , April 1974
Deviations:
yes
Remarks:
Test performed with three rabbits instead of six
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradonium bromide
EC Number:
214-291-9
EC Name:
Tetradonium bromide
Cas Number:
1119-97-7
Molecular formula:
C17H38N.Br
IUPAC Name:
N,N,N-trimethyltetradecan-1-aminium bromide
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
The test was conducted with a white powder diluted in distilled water to 0.5 % (w/w)

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF-Russian strain
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzuchtanstalt WIGA, D-8741 Sulzfeld
- Weight at study initiation: 1900-2150 g
- Housing: Single cages, 45x90 cm with a floor of wire netting
- Diet: free access to feed pellets (green rabbit KFK 7112)
- Water: free access to fresh water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 50±10

Test system

Vehicle:
water
Controls:
other: Only the right eyes were treated. The left eye remained untreated and served as a control.
Amount / concentration applied:
0.1 mL of 0.5% w/w tetradonium bromide in destilled water
Duration of treatment / exposure:
0.1 mL of the test material was placed in the right eye and the lid held together for one second. Eyes were washed with 20ml 0.9% saline solution after 24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 48 h = 0
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #3
Time point:
other: 0h /24h /48h /72h
Score:
0
Max. score:
4
Reversibility:
other: no observed effects Score = 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
Score after 48 h = 0
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
other: 0h /24h /48h /72h
Score:
0
Max. score:
2
Reversibility:
other: no observed effects Score = 0
Irritation parameter:
conjunctivae score
Remarks:
Rednes
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
Score after 48 h = 0
Irritation parameter:
conjunctivae score
Remarks:
Rednes
Basis:
animal: #2, #3
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
Score after 72 h =0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 48 h = 0
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
Score after 72 h = 0
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the experimental conditions described in the report the testing revealed a positive reaction in all the three rabbits. Therefore the preparation must be designated as eye irritant.
Executive summary:

3 albino male rabbits (SPF-Russian strain) were treated in the right eye with 0.1 mL ( 0.5 % (w/w cetrimide in distilled water). Left eye remained untreated and served as a control. The lid was held gently together for a second and the eye examined 1 h, 24 h, 48 h, 72 h and 6 days after treatment. The reaction was scored according to grades of occular lessions. Observed effects were "conjunctiva chemosis" and conjunctiva rednes. One rabbit showed effect on cornea. Effects were observed after 24 hour and decreased over time. After 72 hours all scores were 0