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Description of key information

From both the eye and skin irritation study, Hardener V 217 (ZEH 2017) is highly irritating of corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept 19 1983 - Nov 1 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out according to OECD 404.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
same as guideline
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr Karl Thomae Gmbh, Biberach
- Male and female: 3 of each
- Weight at study initiation: 2.2 - 2.5kg
- 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 28 1983
Type of coverage:
other: patch test
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5ml on approx. 6 cm²
- Concentration: 100%
Duration of treatment / exposure:
4 hours
Observation period:
1 and 24 hours after removal of dressing
after 48 and 72 hours and 6, 8, 10, 13 16, 20 and 24 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 2.5x2.5cm
- Type of wrap if used: linen patch covered with polyethylene film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: see tab with other information
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 6d
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 6d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 6d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 6d
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 6d
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 6d
Irritant / corrosive response data:
see attached results
Other effects:
necrosis developed in the area of application on all animals 1 hour to 3 days after removing the patch. after 8-13 days, hard, reddish-brown scabs developed in the area of application, and these detached on days 16-20, and scarred structures remained after 24 days.

see attached results

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Hardener V 217 showed a moderately irritant effect (index 4.42/8) on the skin of male and female rabbits. Because necrosis occured, it is necessary for the evaluation to be quoted as extremely irritant of corrosive.
Executive summary:

In order to test the acute skin irritation effect, Hardener V 217 was applied to the shaven dorsal skin or rabbits. The product was admintsered undiluted, and the exposure time in the patch test was 4 hours.

Result: Hardener V 217 showed a moderately irritant effect (index 4.42/8) on the skin of male and female rabbits. Because necrosis occured, it is necessary for the evaluation to be quoted as extremely irritant of corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
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.
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
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
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)

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

see result tables

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Hardener V 217 showed a moderately irritant effect (index 4.42/8) on the skin of male and female rabbits. Because necrosis occured, it is necessary for the evaluation to be quoted as extremely irritant of corrosive.

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.


Justification for selection of skin irritation / corrosion endpoint:
The study was carried out according to OECD 404.

Justification for selection of eye irritation endpoint:
The study was carried out according to OECD 405.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

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