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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:
03 September 2006 to 14 September 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24th April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
EPA 712-C-98-195 (August 1998)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
466-080-8
EC Name:
-
Molecular formula:
C23H31N3O4
IUPAC Name:
466-080-8
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Name: LFC 2098
Product/common name: LFC 2098
Purpose: Industrial chemical
Colour: white
Physical state: solid, powder
Purity: 99.69%
Storage: at room temperature, protected from light
Molecular formula: C23H3104N3
Molecular weight: 413
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
New Zealand White Rabbits HsdIf:NZW. Source: Harlan Winkelmann GmbH, D-33l78 Borchen
Three female animals were used.
Body weight at the commencement of the study: 2.2, 2.2, 2.2 kg
The animals were derived from a controlled full barrier maintained breeding system (SPF)
According to Art. 92, No.7 of the German Act on Animal Welfare the animals are bred for experimental purposes.


ENVIRONMENTAL CONDITIONS
Semi-barrier in an air conditioned room
Temperature: 18 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to ssniff K-H, 4 mm V2333-000 complete diet for rabbits - maintenance, rich in crude fibre, totally pathogen free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatization period

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 0.1 g ofthe test item was applied to the test site
Duration of treatment / exposure:
The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids
were then gently held together for about 1 second in order to prevent loss of the material.
Observation period (in vivo):
Animals were observed for 72 hours after dosing
Number of animals or in vitro replicates:
3 animals
Details on study design:
The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids
were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The eyes were not rinsed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of3 female NZW — rabbits (HsdIf:NZW) at a dose of 0.1 g per application site. The untreated other eye served as control.
Observations were calculated and compared to the control eyes, 1 h, 24 h, 48h and 72 hours post-dose. Signs of imitation were still observed at the 72 hours readings on animal No. 1; therefore, it was additionally observed 96 hours post—dose.
Animal No. 1 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1-hour post instillation. 24, 48 as well as 72 hours post instillation redness grade 1 of the conjunctivae was recorded. 96 hours post instillation no signs of irritation were recorded.
Animal No. 2 showed redness grade 1 of the conjunctivae 1, 24 as well as 48 hours post instillation. No signs of irritation were recorded 72 hours post instillation
Animal No. 3 showed redness as well as chemosis grade 1 of the conjunctivae 1 hour post instillation. 24, 48 as well as 72 hours post instillation no signs of irritation were recorded.
No other toxic effects were observed.
The eyes were not rinsed.
Throughout the observation period no weight loss was recorded in the test animals.
The calculated mean scores did not exceed the limit values according to Directive 93/21 EEC in any case.

Any other information on results incl. tables

Body weight

Animal no. Weight (kg)
Start of study End of studay
1 2.2 2.3
2 2.2 2.3
3 2.2 2.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item LFC 2098 produced slightly imitating effects, which were reversible, but no corrosion.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 BBC) the test item LFC 2098 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

On the basis of the test results given below and in conformity with the criteria given in Annex VI of the Directive, the substance should be: not classified