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EC number: 292-053-3 | CAS number: 90530-15-7
Endpoint summary
Administrative data
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
- 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.
- 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.
Reference
see attached results
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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
- 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.
Reference
see result tables
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
