Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Endpoint summary
Administrative data
Description of key information
NA-DETA is irritating to skin and to eyes.
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:
- 1986-09-09 to 1986-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The test substance was applied once to skin with a patch
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 73 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Dry and rough skin was observed in 2 animals from 72 hours up to 7 days p.a.
Scaly skin observed in one animal from 72 hours up to 7 days p.a. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- NA-DETA was evaluated as irritating to skin according to DSD 67/548/EEC and should be classified as Xi; R38.
- Executive summary:
The skin irritation potential of NA-DETA was investigated according to OECD 404. NA-DETA induced moderate erythema and oedema, justifying the classification. The effects were reversible within 14 days of observation period.
NA-DETA should be classified as Xi;R38 according to DSD 67/548/EEC and for practical reasons it is proposed to classify as Warning, Category 2; H315 according to Regulation (EC) No 1272/2008.
Reference
NA-DETA should be classified according to Directive 67/548/EEC but not to Regulation (EC) No 1272/2008.
For practical reasons it is proposed to classifiy according to both regulation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-09-09 to 1986-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- NA-DETA should be classified as Irritating to eyes (Category 2) according to Regulation (EC) No 1272/2008.
- Executive summary:
The eye irritation potential of NA-DETA was investigated according to OECD 405. NA-DETA induced moderate irritation effects on eyes, justifying the classification. The effects were reversible within 7 days of observation period.
NA-DETA should be classified as Warning, Category 2; H320 according to Regulation (EC) No 1272/2008 and for practical reasons it is proposed to classify as Xi;R36 according to DSD 67/548/EEC.
Reference
NA-DETA should be classified according to Regulation (EC) No 1272/2008 but not according to Directive 67/548/EEC.
For practical reasons it is proposed to classify according to both regulations.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of NA-DETA was investigated according to OECD 404. NA-DETA induced moderate erythema and oedema. The effects were reversible within 14 days of observation period.
The eye irritation potential of NA-DETA was investigated according to OECD 405. NA-DETA induced moderate irritation effects on eyes. The effects were reversible within 7 days of observation period.
Justification for selection of skin irritation / corrosion endpoint:
Scientifically well performed study
Justification for selection of eye irritation endpoint:
Scientifically well performed study
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
NA-DETA should be classified as Xi;R38 according to DSD 67/548/EEC and for practical reasons it is proposed to classify as Warning, Category 2; H315 according to Regulation (EC) No 1272/2008.
S
NA-DETA should be classified as Warning, Category 2; H319 according to Regulation (EC) No 1272/2008 and for practical reasons it is proposed to classify as Xi;R36 according to DSD 67/548/EEC.
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