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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:
1999-02-22 until 1999-02-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 Feb., 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
EPA 712-C-96-195, June 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-970-4
EC Name:
-
Cas Number:
1266545-66-7
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction product of (C8 – C18) aliphatic primary amines (partly unsaturated) and p-phenetidine with a mixture of aromatic isocyanates comprising of primarily 4,4’-methylenediphenyl diisocyanate and 4-methyl-m-phenylene
Details on test material:
NA

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg, Germany
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet rabbit, rich in crude fibre, totally pathogen free-TPF
- Water: tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 55+ 10%
- Air changes: :at least 10 x / hour
- Photoperiod: artificial light, lighting regime 12 : 12 hours, light 6.30 -18.30

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
72 hours (same as the observation period as the test substance was not washed away)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 female animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed

SCORING SYSTEM: as indicated in the OECD Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean score animal 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean score animal 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
mean score animal 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean score animal 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The application of the test item at a dose of 0.1 g caused minimal blepharospasm in all animals immediately after the application.
1 hour after application a slight erythema of the conjunctivae was visible two of three animals.
No signs of irritation were visible at the 24 h reading in all of the 3 test animals.
No Cornea lesions were found upon fluorescein examination at the 72 h reading.
The test item produced no corrosion or irreversible effects in any of the animals.
No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Under the study conditions it was concluded that the test item caused no irritation and no corrosive effects to the eyes of rabbits.
Executive summary:

The test item was tested for its eye irritation/ corrosion properties according to EU Method B.5, OECD Guideline 405 and EPA OPPTS 870.2400. In the available study the test item was applied to the lower conjunctival sac of one eye of 3 rabbits at a dose of 0.1 g per application site and it was not rinsed thereafter. The untreated eye served as control. Observations were calculated and compared to controls 1, 24, 48 and 72 hours after application of the test item. Application of the test item caused minimal blepharospasm in all animals immediately after application and 1 hour after application a slight erythema of the conjunctivae was visible. No signs of irritation were visible at the 24 hours reading in all of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. Thus, the mean cornea, iris, conjunctivae score redness and chemosis for all 3 animals was 0. No corrosion effect were observed. Under the study conditions the test item was considered to have no irritation and no corrosive effects to eyes of rabbits.