Registration Dossier

Administrative data

Description of key information

The test item is not irritating to skin but irritating to eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 2.16 kg


ENVIRONMENTAL CONDITIONS
not reported
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: unchanged (melted by 34°C), ca. 1 mL



Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cmx2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing: no
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. One drop of the test substance was applied to the conjunctival sac of one eye of 2 animals. The NaCl-treated adjacent eye served as a control.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 2.29 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: The NaCl-treated adjacent eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): one drop undiluted
(melted by 34°C), which is equivalent to ca. 50 µL
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days

Descriptive scores of the raw data have been converted to Draize numerical scores.

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Skin irritation was tested using an internal standard method (BASF test). The study meets scientific standards with acceptable restrictions (limited documentation). Two white rabbits were treated for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the undiluted test substance. The test substance induced slight erythema after 20 h occlusive exposure in 1/2 animals, which was reversible within 6 d. No oedema was present, however slight scaling was noted from 24 h onwards which was not reversible within 8 days. Mean scores were 0.35 for erythema and 0 for edama. Thus, the test item is not considered skin irritating.

According to this result, Cosumser Product Testing applied 0.5 g of the test substance to the skin of New Zealand white rabbits for 24 to abraded as well as intact skin and measured erytheme and edema 24 and 72 h post-application (occlusive conditions). An overall irritation score of 0.23 was noted, indicating that the substance is not irritating to the skin.

Eye irritation:

 

Eye irritation was tested using an internal method (BASF test). The study meets scientific standards with acceptable restrictions (limited documentation, application amount not defined). One drop of the test substance was applied to the conjunctival sac of one eye of 2 rabbits. Reversible corneal opacity, conjunctivae redness and chemosis were observed. Mean scores were 2 for cornea, 0 for iris, 3 for conjunctivae and 0.65 for chemosis. Thus the test item is irritating to eye.

Furthermore, Consumer Product testing evaluated the potential of the test item to induce eye irritation. Therefore, 100 mg of the test substance was instilled in the right eye of New zealand White rabbits (6 rabbits in total); the left untreated eye served as control. Treated eyes of all rabbits remained unwashed for 24 h. Readings were taken 1, 2, 3 and 7 days post-application. The total irritation score (mean, 24, 48, 72 h all animals) was 17.4; in two animals, corneal opacity was still visible after 7 days. Ths, the test article is moderately irritating.


Justification for selection of skin irritation / corrosion endpoint:
The Key study was selected (study with acceptable restrictions).

Justification for selection of eye irritation endpoint:
The Key study was selected (study with acceptable restrictions).

Effects on eye irritation: irritating

Justification for classification or non-classification

Classification for skin irritation is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

N-Vinylcaprolactam is considered as irritating to eye (EU: R36 and GHS: Cat. 2, H319) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.