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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:
Sept 19 1983 - Oct 31 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out according to OECD 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
same as guideline
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Hardener V 217
IUPAC Name:
Hardener V 217
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Hardener V 217
- Physical state: liquid
- Analytical purity: 100%

Test animals / tissue source

Species:
rabbit
Strain:
other: small white Russian, CHBB-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr Karl Thomae Gmbh, Biberach
- Female: 2 animals
- Weight at study initiation: 2.3 - 2.4kg
- Housing: individual housing in stainless steel cages
- Diet: ad libitum - K4 complete feed for rabbits, Ssniff Versuchstier-Diäten Gmbh, 4770 Soest
- Water: ad libitum - tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rhythm

IN-LIFE DATES: From: Oct 4 1983 To: Oct 7 1983

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
after 1 hour, 24, 48 and 72 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- no washing
- Time after start of exposure:

SCORING SYSTEM: Draize appraisal method (see attached)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2.66
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2.66
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritant / corrosive response data:
Hardener V 217 has an irritation index of 91.75
Other effects:
1 animal made complaining noises

Any other information on results incl. tables

see result tables

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Hardener V 217 showed an extremaly irritant or corrosive effect, the irritation index being 91.75/110, on eye and the muicosa of female rabbits.
Executive summary:

In order to test the acute irritant effect on eyes and mucosa, hardener V 217 was administered undiluted to the eyes or eyelid sacs of female rabbits.

Result: Hardener V 217 showed an extremaly irritant or corrosive effect, the irritation index being 91.75/110, on eye and the muicosa of female rabbits.

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